Download Family-Centered Care and Treatment for Adults in Low

Author: K. Mona Moore, PA-C, MA, AAHIVS
Acknowledgements:
The development of this clinical standard operating procedure (SOP) template was led by Nicole Buono,
Project HEART Director and Elizabeth Flanagan, Senior Technical Officer as an activity of the Elizabeth
Glaser Pediatric AIDS Foundation’s (EGPAF’s) Project HEART (Cooperative Agreement
U62/CCU123541) in cooperation with EGPAF’s Technical Advisory Group (TAG) focused on supporting
countries in the adaptation and implementation of the World Health Organization’s revised 2010
guidelines for HIV prevention, care and treatment. The clinical SOP template provided in this document
was conceptualized based on feedback and review by technical directors, field-based clinical staff, and
other senior staff. During the process, members of a technical review team proposed, agreed upon, and
worked with the author to develop the template for SOPs for HIV prevention, care and treatment to meet
the needs of country teams.
The efforts of numerous individuals should be recognized. We would like to thank the following
individuals for their contributions and assistance in the review and finalization of this SOP template:




EGPAF Senior Technical Reviewer: RJ Simonds, Vice President of Program Innovation and
Policy
EGPAF Technical Review Team: Serge Agbo, Stephen Lee, Mary Morris, Appolinaire Tiam,
Sue Willard
François-Xavier Bagnoud Center at the School of Nursing, University of Medicine and
Dentistry of New Jersey for support with editing, proofreading, and formatting: Virginia
Allread, Deborah Hunte, Karen Forgash, and Mary Jo Hoyt
EGPAF Cover Design: Katherine Warminsky
This publication was supported by the Centers for Disease Control and Prevention (CDC) through
Cooperative Agreement U62/CCU123541. Its contents are solely the responsibility of the authors and do
not necessarily represent the official views of the Centers for Disease Control and Prevention. We also
acknowledge the efforts of the author, technical review team, and editorial staff to ensure the quality of
the publication. Finally, we would like to acknowledge the tireless efforts of our partners and staff
around the world to eliminate pediatric AIDS, and the women, children and families in the countries
where we work.
Table of Contents
Acronyms and abbreviations ............................................................................................................................................. 5
Introduction ................................................................................................................................................................................... 7
Enrollment into care and ARV initiation, if eligible ............................. 12
SOP 1: Registration and enrollment............................................................................................................................16
SOP 2: Initial assessment visit to determine eligibility....................................................................................18
SOP 3: Clinical visit — clients not eligible for ART .............................................................................................24
SOP 4: Clinical visit — clients eligible for ART ......................................................................................................27
SOP 5: Treatment readiness and adherence counseling................................................................................34
SOP 6: ART regimen selection .......................................................................................................................................40
SOP 7: Conduct routine laboratory monitoring ...................................................................................................52
Ongoing Care and Management, Including Treatment Failure .......... 55
SOP 8: Provide CTX prophylaxis....................................................................................................................................58
SOP 9: Provide INH preventive therapy .....................................................................................................................63
SOP 10: Management of common symptoms and complications of HIV .............................................68
SOP 11: Management of common HIV-associated coinfections ................................................................75
SOP 12: Recognition of adverse events and ART toxicity .............................................................................79
SOP 13: Recognition of treatment failure and when to switch ART regimens ..................................89
SOP 14: Switching to second-line ART regimens................................................................................................94
SOP 15: Switching to third-line ART regimens...................................................................................................101
Integrated Sexual and Reproductive Health ...................................... 105
SOP 16: Contraception ......................................................................................................................................................108
SOP 17: STI screening for adults and adolescents..........................................................................................112
SOP 18: Cervical screening ............................................................................................................................................118
SOP 19: ART and HIV-related treatment for WRA.............................................................................................122
SOP 20: Counseling and support for adults and adolescents living with HIV ................................127
SOP 21: HIV prevention for people living with HIV ...........................................................................................129
Nutrition ................................................................................................ 132
SOP 22: Nutritional assessment ..................................................................................................................................134
SOP 23: Determine level of nutritional support needed ................................................................................139
SOP 24: Develop nutrition care plan .........................................................................................................................141
Mental Health ........................................................................................ 143
SOP 25: Conduct mental health assessment ......................................................................................................145
SOP 26: Conduct mental status examinations ...................................................................................................148
SOP 27: Develop mental health care plan..............................................................................................................156
SOP 28: Provide links to additional care sites ....................................................................................................159
Appendices ........................................................................................... 162
Appendix A: Patient adherence record form .......................................................................................................162
Appendix B: Clinical algorithms ..................................................................................................................................173
Appendix C: How to do a 24-hour dietary recall ................................................................................................186
Appendix D: Patient nutrition management form (adult)..............................................................................188
Appendix E: Nutritional assessment tool for PLWHIV ...................................................................................190
Illustrative examples of national adaptations ......................................................................................................191
List of tables and figures ..................................................................... 192
References and resources .................................................................. 196
4
Acronyms and abbreviations
>, <
/r
3TC
ABC
AFB
AIDS
ALT
ANC
ART
ARV
ASCUS
AST
ATV
AZT
AV
BMI
BP
CD4
CDC
CMV
CNS
CSF
CT
CTX
CTC
CXR
d4T
ddI
DHHS
DLV
DRV
DNA
DNA PCR
EFV
ETR
ETV
FP
FPV
FTC
GFR
HBV
HCV
HIV
HSV
Greater than, less than
Ritonavir (see also “RTV”)
Lamivudine
Abacavir
Acid-fast bacilli
Acquired immune deficiency syndrome
Alanine amino transferase
Antenatal care
Antiretroviral therapy
Antiretroviral or antiretroviral drug
Atypical cells of undetermined significance
Aspartate aminotransferase
Atazanavir
Zidovudine (also known as ZDV)
Arteriovenous or atrioventricular
Body mass index
Blood pressure
Cluster of differentiation 4
U.S. Centers for Disease Control and Prevention
Cytomegalovirus
Central nervous system
Cerebrospinal fluid
Computerized tomography
Cotrimoxazole
Care and treatment center/clinic
Chest X-ray
Stavudine
Didanosine
Department of Health and Human Services
Delavirdine
Darunavir
Deoxyribonucleic acid
DNA polymerase chain reaction
Efavirenz
Etravirine
Etravirine
Family planning
Fos-amprenavir
Emtricitabine
Glomerular filtration rate
Hepatitis B virus
Hepatitis C virus
Human immunodeficiency virus type 1 (HIV-1)
Herpes simplex virus
5
INH
IRIS
IUD
IV
KS
L
LPV
LSIL
MRI
mL
mmol
MVC
NASCOP
NFV
NNRTI
NVP
OD
PCP
PCR
PI
PIT
PLHIV
PMTCT
PO
RAL
RNA
RPR
RTV
sd-NVP
SJS
SOP
SQV
SRH
STI
TB
TDF
TPV
VAS
VDRL
VI
WBC
WHO
WRA
Isoniazid
Immune reconstitution inflammatory syndrome
Intrauterine device
Intravenous
Kaposi’s sarcoma
Microliter (cubic millimeter, mm3)
Lopinavir
Low grade squamous intraepithelial lesion
Magnetic resonance imaging
Milliliter
Millimole
Maraviroc
National AIDS and STI Control Programme (Kenya)
Nelfinavir
Non-nucleoside reverse transcriptase inhibitor
Nevirapine
Once daily
Pneumocystis carinii (now jiroveci) pneumonia
Polymerase chain reaction
Protease inhibitor
Pill Identification Test
People living with HIV
Prevention of mother-to-child transmission
By mouth, orally
Raltegravir
Ribonucleic acid
Rapid plasma reagent syphilis test
Ritonavir
Single-dose nevirapine
Stevens-Johnson syndrome
Standard operating procedure
Saquinavir
Sexual and reproductive health
Sexually transmitted infection
Tuberculosis
Tenofovir
Tipranavir
Visual Analogue Scale
Venereal Disease Research Laboratory
Visual inspection (of uterine cervix)
White blood cell
World Health Organization
Women of reproductive age
6
Introduction
Who should use the templates for SOPs?
The template is intended as a resource to support clinical and other staff engaged in
national, program, district and facility-level planning for implementing HIV care and
treatment programs in low-resource settings for adults.
What is the purpose of these templates?
SOPs provide a comprehensive framework of operational guidelines to assist in the
translation of recommended adult HIV treatment guidelines and adult service delivery
approaches into steps in the actual delivery of services and care. SOPs help to define
and promote best practices, and maintain consistency, quality, and effectiveness of
service delivery. SOPs support evidence-based service delivery practices to improve
outcomes for clients and their families by promoting consistent approaches in service
delivery, information provision and service management.
SOPs are useful to:
 Facilitate comprehension of technical information related to HIV care and treatment
and maintain consistency in its application to daily practice
 Increase health team’s capacity to deliver integrated HIV services and care
 Assist health team to deliver integrated adult HIV services that comply with national
guidelines, policies and protocols
 Provide a facility-specific record of standards of service delivery adhered to
 Provide managerial and clinical staff with step-by-step operational information to
organize and deliver HIV services
 Promote safe and effective patient care.
 Increase consistency of service provision
 Improve communication and referral pathways
 Reduce provider mistakes and omissions that may harm patients
SOPs can also:
 Assist staff to perform tasks in a way that optimizes patient safety, positive care
outcomes, and efficient service delivery
 Introduce new elements of care
 Prepare new staff for service delivery
 Reinforce standards and processes for existing staff
 Provide a mechanism to evaluate service delivery, serve as checklist for supervisors
to monitor job performance, and provide a framework for supportive supervision.
Provide guidance to quality improvement initiatives.
 Guide the referral and follow up process to assure that patients still get the care they
need when services are not within the capacity of a health facility or level of care
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SOPs are “working documents” that should be revised and updated regularly to assure
compliance with new treatment regimens and approaches to care
How were the templates developed and reviewed?
The draft SOPs were prepared by consultants working closely with EGPAF technical
staff in Washington DC. The final version was prepared following additional review of
the draft for completeness and technical accuracy in Washington D.C. and by EGPAF
staff in country offices throughout Africa and other countries where the Foundation is
working.
The SOPs were developed following extensive review of many excellent global, and
country-specific adult HIV treatment guidelines, adult HIV SOPs and other related
documents. A complete list of the references reviewed to inform the development of
these SOPs is provided at the end of this document. When tables or charts appear in
this document originated from source documents reviewed, the source document is
acknowledged.
How should the templates be used?
In many countries, national guidelines have been or are now being revised to
incorporate 2010 WHO recommendations that define standards of HIV care and service
delivery approaches and provide evidence-based clinical protocols and treatment
regimens. The purpose of this SOP template is to provide guidance on how to
operationalize global and national guidelines and develop standardized steps for day-today implementation of clinical, counseling and care services required to provide
integrated adult HIV interventions. In many countries, adult HIV services are provided
in a wide range of settings with varying levels of human, material, and financial
resources.
This SOP template was developed to be adapted and utilized at national and local
levels to reduce time spent locally developing SOPs. As new treatment
recommendations and service delivery approaches evolve, SOPs can help to develop,
standardize and implement realistic local approaches to the delivery of new or
expanded services. Their use can facilitate seamless, uninterrupted adult HIV service
delivery even when the continuum of care is provided by multiple care sources.
What is the audience for the adult HIV SOP template?
Audience for the Adult HIV SOPs includes:
 Physicians, medical officers, clinical officers, nurse-midwives, nurses, counselors,
peer educators
 Laboratory and pharmacy staff
 Health facility managers and District Health Team members
These SOPs are aimed at HIV service sites that refer to care and treatment clinics
(CTCs) that provide more extensive tertiary care. They cover basic HIV treatment; care
and support that can be delivered at health center level, and suggest referral to the next
upward level of care where complicated cases can be handled. Adaptation of these
SOPs at country level will need to consider national policy for task sharing of HIV
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treatment-related tasks and responsibilities, and national guidelines for second and third
line treatment regimens when required.
What are the objectives of the adult HIV SOP template?
This set of SOPs on adult HIV addresses both HIV service delivery and treatment
objectives. Service delivery objectives include the following global health priorities:
 Provide a comprehensive continuum of HIV treatment and care
 Integrate service delivery for HIV, tuberculosis (TB), maternal child health, sexual and
reproductive health (SRH)
 Decentralize service delivery to health facilities
 Enable health facilities to effectively initiate, monitor, manage or refer HIV care and
treatment, and
 Facilitate implementation of task shifting, or nurse-initiated HIV treatment according
to national guidelines
Treatment objectives include:
 Emphasis on earlier HIV diagnosis, assessment of antiretroviral therapy (ART)
eligibility and treatment initiation for HIV
 Prevent progression of HIV disease and avert AIDS-related deaths
 Increase use of less toxic ART regimens
 Early recognition of side effects and adverse events and timely, appropriate
treatment modification
 Increase retention of patients and adherence with lifelong therapy
 Prevent new infections and re-infection
 Routine clinical assessment after initiating ART
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Table 1: WHO recommendations at a glance
When to start
All adolescents and adults including pregnant women with HIV
infection and CD4 counts of ≤350 cells/mm3, should start ART,
regardless of the presence or absence of clinical symptoms.
Those with severe or advanced clinical disease (WHO clinical
stage 3 or 4) should start ART irrespective of their CD4 cell
count.
What to use in first-line
therapy
First-line therapy should consist of an NNRTI + two NRTIs, one
of which should be zidovudine (AZT) or tenofovir (TDF).
Countries should take steps to progressively reduce the use of
stavudine (d4T) in first-line regimens because of its wellrecognized toxicities.
What to use in secondline therapy
Second-line ART should consist of a ritonavir-boosted protease
inhibitor (PI) plus two NRTIs, one of which should be AZT or
TDF, based on what was used in first-line therapy. Ritonavirboosted atazanavir (ATV/r) or lopinavir/ritonavir (LPV/r) are the
preferred PIs.
Laboratory monitoring
All patients should have access to CD4 cell count testing to
optimize pre-ART care and ART management. HIVRNA (viral
load) testing is recommended to confirm suspected treatment
failure. Drug toxicity monitoring should be symptom directed.
HIV/TB coinfection
Irrespective of CD4 cell counts, patients coinfected with HIV and
TB should be started on ART as soon as possible after starting
TB treatment.
HIV/HBV coinfection
Irrespective of CD4 cell counts or WHO clinical stage, patients
who require treatment for HBV infection should start ART. Firstline and second-line regimens for these individuals should
contain TDF and either emtricitabine (FTC) or lamivudine (3TC).
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
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Table 2: Summary of changes in 2010 WHO recommendations
On the basis of the available evidence the panel recommended
ART initiation for all PLHIV with a CD4 count of ≤350 cells/mm3
Earlier initiation of ART
and, if CD4 testing is not available, for those with WHO clinical
stage 3 or 4.
Simplified, less toxic
ARV drugs for use in
first-line and secondline therapy
While current options have permitted rapid ART scale-up, the cost
in terms of side effects has been considerable. There is a clear
demand both from PLHIV and health-care providers to phase in
less toxic ARVs while maintaining simplified fixed-dose
combinations. Available evidence indicates that initial ART should
contain an NNRTI (either NVP or EFV) plus two NRTIs, one of
which should be 3TC or FTC and the other AZT or TDF. Countries
are advised to choose one second-line regimen for individuals with
first-line failure.
Promoting the initiation
of ART for all those with
HIV/TB co infection
While recognizing that this recommendation will be challenging for
many countries with a significant HIV and TB burden, the panel
placed high value on reducing the impact of TB on societies and on
the data demonstrating a reduction in all-cause mortality among
individuals provided with TB therapy and ART.
Promoting improved
HBV diagnosis and
more effective treatment
of HIV/HBV co infection
Evidence supports the initiation of ART, irrespective of WHO
disease stage or CD4 cell count, for all those with HIV/HBV
coinfection and chronic active hepatitis B when treatment is
indicated for hepatitis B. However, there is no agreed definition of
chronic active hepatitis in resource-limited settings. Despite this,
the panel felt that it was necessary to include the principles of
optimum care for those with HIV/HBV coinfection and bring these
into alignment with recommendations in well-resourced settings.
There is an urgent need to develop diagnostic criteria to identify
individuals with HIV/HBV coinfection who need treatment in
situations where HBV DNA and liver biopsy are not routinely
available.
More strategic
monitoring for ARV
efficacy and toxicity
While laboratory monitoring should not be a barrier to initiating
ART, the newly recommended ARV regimens may require more
laboratory monitoring than current regimens, especially in
individuals at higher risk for adverse events. A phased-in approach
to the use of viral load testing, if feasible, will improve the
identification of treatment failure.
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
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Enrollment into care and ARV initiation,
if eligible
Background
A key component of a package of comprehensive HIV care is early assessment for ART
eligibility, by clinical assessment and CD4 testing when feasible, to increase early
treatment initiation and effective management of HIV. It is expected that clients will have
already received HIV diagnosis before presenting for further assessment or enrollment
in care.
Previous HIV testing and referral for enrollment in care may have taken place at any of
the following where integrated HIV testing now occurs: HIV testing and counseling/VCT
services, ANC/PMTCT, labor and delivery services, postnatal care, outpatient clinic,
family planning/SRH clinics, STI services, TB service, inpatient hospital services either
prior to or after discharge, PLWHIV or other community support groups, home-based
care program, or self-referral. Patients who self-identify as HIV positive should be retested so that HIV status is confirmed for the patient record.
The first visit (SOPs 1 and 2) provides an opportunity to offer preventive and supportive
care and introduce or reinforce information about the progression of HIV disease,
prophylactic treatment, and ART. Regular routine care (SOPs 3 and 4) beginning as
soon as possible after HIV diagnosis can maintain health and delay progression of HIVrelated complications and conditions. The first clinical visit provides an opportunity to
provide preventive and supportive care and introduce or reinforce information about the
progression of HIV disease, prophylactic therapy, and ART.
Each country program will have nationally-recommended visit schedules, visit content
and treatment regimens and these SOPs for ART and ART-associated care and
treatment will need to be modified accordingly.
Adherence (SOP 5)
Adherence to ART is essential for successful treatment and sustained viral control. As
evidence accumulates around the benefits of early HIV treatment in preventing HIV
transmission, adherence to ART is of greater significance for HIV transmission
prevention. Clients who do not adhere to their regimens are more likely to develop drug
resistance, become ill, and require 2nd line — even 3rd line — ART. Adherence levels of
95% or greater have been shown to maximize effectiveness of ART and minimize the
development of drug resistance.
Adherence to a lifelong HIV treatment regimen and effectively incorporating the many
associated changes in lifestyle into regular daily life are challenges that are facilitated by
the support of partners, family, and community. Compassionate and comprehensive
counseling on treatment readiness and adherence from counseling and clinical staff is
the cornerstone of successful family-based ART programs.
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Adherence to other HIV-associated treatment regimens, such as cotrimoxazole (CTX)
prophylaxis, and to clinic visit schedules and referrals are also an important element of
successful outcome of HIV treatment programs.
The goals of treatment readiness assessment and adherence counseling include:
 To educate HIV positive patients eligible for ART about ART as part of
comprehensive care to improve health and prolong life
 To assess patient readiness to start and maintain a lifelong ART regimen
 To identify and address barriers to adherence, adherence problems and underlying
factors negatively influencing adherence
 To identify the need for additional resources and adherence support
Treatment readiness counseling or pre-ART counseling is usually conducted on an
individual basis. Routine adherence monitoring can be individual or in treatment
adherence support groups if available and acceptable to the patient, partner and family.
Adherence messages should be standardized in terms of general content, but
individually tailored to reflect the needs of each client and family.
ARV selection and monitoring (SOP 6)
Appropriate selection of initial ART regimen (SOP 6); quality clinical, laboratory (SOP 7)
and adherence monitoring; timely changes in therapy when indicated; and rational
sequencing of replacement ARVs when initial regimens fail improves quality of life for
the patient and helps to preserve future treatment options.
Definitions
 Immunological staging: The WHO immunologic staging system helps to assess
the degree of damage to the immune system cause by HIV disease. Immunological
staging, where available, is used with WHO clinical staging to plan treatment and
care options.
 Clinical staging: The clinical stages identify a progression sequence from least to
most severe (numbers 1 through 4) — the higher clinical stage, the poorer the
prognosis. For classification purposes, once a stage 4 clinical condition has
occurred, the individual continues to be classified as clinical stage 4, even in the
context of improvements in health related to ART. Clinical staging events can also
be used to identify the response to ART if there is no access to viral load or CD4
testing.
 CD4: CD4 cells are a type of white blood cell that coordinates the immune system’s
response to certain microorganisms and viruses. They are the cells infected by HIV.
CD4 test results are used to determine immunological staging. Staging helps in the
determination for starting and managing ART and prophylaxis for opportunistic
infections.
 Viral load: Viral load is a laboratory test (HIVRNA) that measures how much virus is
13
in the blood of an infected person. It can be used to diagnose HIV (a positive
virological test indicates infection) but it is more commonly used to measure viral
activity and the effectiveness of ART. An effective ART regimen should reduce viral
load, preferably below the level of detection (e.g. less than 50 copies/ml).
 Antiretroviral (ARV) prophylaxis: Short-term use of ARV medications to reduce
the risk of MTCT.
 Prophylaxis for opportunistic infections (OIs): Medication or treatment used to
prevent illness. In HIV-exposed infants, HIV-infected infants, children and adults,
CTX prophylaxis is used to prevent many infections. Likewise, isoniazid (INH)
preventive therapy is used in eligible patients to prevent TB.
 Adherence to treatment: Adherence means that the adult takes ART exactly as
prescribed, every day, without missing doses. Adherence is required for ART to be
effective; poor adherence usually results in the development of drug-resistant virus
and disease progression. The standard clinical definition of adherence has been
taking at least 95% of medications the right way, at the right time. Over time, this
definition has been broadened to include more factors related to continuous care,
such as following a care plan, attending scheduled clinic appointments, picking up
medicines on time, and getting regular CD4 tests.
 Immune reconstitution inflammatory syndrome (IRIS) is a spectrum of clinical
signs and symptoms associated with immune recovery brought about by a response
to ART. This is the result of either the unmasking of latent or subclinical infection or
the reactivation of previously diagnosed, and often treated, conditions (infectious or
non-infectious).
Policy
1. Patients should be referred to other health services or community services as
needed. Care should be coordinated as much as possible in order to reduce the
burden of visits on the individual.
2. A chronic care model should be utilized so that individuals with HIV are seen
regularly and routinely for monitoring and health promotion activities as well as seen
for episodic care in the event of acute illness.
3. A multidisciplinary team approach should be utilized for the care of men and women
living with HIV. Teams may include a nurse, prescribing clinician, pharmacist,
counselor, social worker or others.
Responsibility at health facility
 A single individual should be assigned at each health facility to establish and
supervise HIV care and treatment; ensure all services meet or exceed national
policies, practices and guidelines; and to conduct quality assurance measures.
 A nurse or prescribing clinician should serve as the team leader in managing the care
of each PLHIV and his or her family.
 ART, CTX prophylaxis and other drugs should be prescribed by a physician, medical
or clinical officer or a nurse with training in care of the HIV exposed child. Where
14
possible this individual should have the support of a multidisciplinary team that
includes health workers that provide counseling and support (which may be a nurse,
counselor, social worker, peer educator, or another trained professional) and
pharmacist who is responsible for dispensing medications. In health facilities staffed
by a single professional, that individual should be trained in HIV and able to fill all
roles.
15
SOP 1: Registration and enrollment
Date of creation or
revision:
Prepared by:
Reviewed by:
Approved by:
Purpose
 To conduct initial assessment, triage to identify appropriate level of enrollment in care
as part of comprehensive care, treatment and support to adults with HIV.
Responsibility
 Triage nurse, registration and intake staff
 Auxiliary nurse
Supplies
1. Space: appropriate intake/registration area with adequate privacy
2. Medical record and relevant registers (HIV client register, ARV, follow-up/default
register, etc) as per national guidelines
3. Intake forms and appointment follow-up cards
4. Unique ART identification card
5. Laboratory test referral request form if required
Procedure
Confirm HIV diagnosis and register/enroll in care
 Greet client and introduce yourself.
 Explain what to expect at this visit.
 Assure client and partner/family (if present) that confidentiality will be maintained, and
that information about the client will only be shared with health workers and case
managers who are directly involved in their care.
 Request medical records that document HIV status and/or referral forms.
 Review patient records for documentation of HIV status or determine need for HIV
testing to establish diagnosis. Provide or refer for counseling, as appropriate
 Conduct patient history to assess:
 Patient reported signs and symptoms of HIV disease, patient understanding of
progression, and current status of HIV disease
 Hospitalizations
 Previous laboratory testing and results, including CD4 cell count
16
 Current and previous HIV and non-HIV medications: what they were prescribed
for, where they were prescribed
 Medication allergies
 Determine any immediate HIV-related medical needs; refer to HIV clinician for acute
management of problems, if required.
 Assess for other pre-existing medical conditions such as TB, diabetes mellitus,
hypertension, chronic liver disease.
 Assess for social issues such as client or family alcohol abuse, psychological or
mental health problems, family violence, joblessness or other issues.
 Conduct mental health assessment.
 Explain process of enrollment, determination of eligibility for ART, and other elements
of HIV care that will take place.
 Explain the clinic operations, including what to do if the patient is sick and how to
change or request an appointment.
 Review:
 Disclosure status
 Family and social support
 Perceived barriers to enrollment in care
 Retention in care
 Adherence to medications
 Prepare a realistic and mutually agreeable visit plan based on initial assessment.
 If patient records include CD4 levels from within the past 6–12 weeks, make
appointment for next clinical visit OR
 Order CD4 testing and other required laboratory tests, set appointment to review
CD4 results
 Initiate enrollment in care by creating an enrollment number and a unique
identification number as per national guidelines.
 Schedule next visit; record appointment in follow-up register.
 Document:
 Create individual client record using HIV chronic care card based on WHO model
or national guidelines; record all findings
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
17
SOP 2: Initial assessment visit to determine eligibility
Date of creation or
revision:
Prepared by:
Reviewed by:
Approved by:
Purpose
 To assess progression of HIV and determine ART eligibility on all newly enrolled
patients as part of comprehensive care, treatment and support. The first clinical visit
may take place on the same day as the registration/enrollment visit if HIV diagnosis is
confirmed and clinic schedule allows, or if the patient is very ill.
Responsibility
 Triage nurse, registration and intake staff, auxiliary nurse
 Physician or clinical officer
 Nurse trained in HIV care and treatment
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, ARV, follow-up/default
register, etc) as per national guidelines
3. Intake forms and appointment follow-up cards
4. TB screening form
5. Laboratory test referral request form if required
Procedure
The first visit provides an opportunity to provide preventive and supportive care
and introduce or reinforce information about the progression of HIV disease,
prophylactic treatment, and ART.
 Greet client and introduce yourself.
 Explain what to expect at this visit.
 Review records from registration/enrollment visit (see SOP 1), confirm unique patient
identification number. If more than a week has passed since registration/enrollment
visit, review with patient:
 Patient status since last visit
 New laboratory results, if any
 Review process of enrollment in care, including planned content of today’s visit.
18
 Assess client familiarity with:
 Concept of positive living
 Knowledge of HIV and ART
 Determine, in consultation with client, if additional HIV counseling is required; provide
or refer for counseling if necessary. See SOPs 25–28 for guidance on the mental
health assessment.
 Explain to client the criteria for ART eligibility, and that regardless of need for
initiation of ART, an individualized program of HIV care will be established during
today’s visit.
 Review medical history in depth.
 Conduct directed medical history focused on:
 Experience with ART and other HIV medications since last visit
 Any HIV medications taken previously
 Medication allergies
 Patient-perceived changes in health status
 Symptoms of possible side effects or toxicities
 Adherence (if applicable)
 Review use of all current medications — HIV, non-HIV and traditional — and
reinforce potential interactions between western medicines and traditional medicines.
 Confirm initial intake information and discuss with HIV clinician before initiating
therapy if required.
 Document vital signs and other physical findings.
 Perform comprehensive physical examination to assess general health and identify
signs of HIV-related conditions, including opportunistic infections (OIs), TB, and STIs.
 Identify symptoms of HIV disease and document.
 Conduct symptomatic screening for TB using national TB screening checklist; and
order TB laboratory confirmation if TB disease suspected.
 Review CD4 result and other laboratory results available in patient record.
 Order additional laboratory tests if required to complete assessment of eligibility for
ART.
 Determine and document WHO HIV staging according to findings from medical
history and physical examination.
 Review results of history, exam, lab results and WHO staging, determine eligibility for
ART.
 Discuss and document ART eligibility findings with client and proceed with visit
19
according to eligibility.
 Inquire about partner, children and other family HIV status and reinforce the concept
of family centered care.
 Review importance of adherence to:
 Clinic visit schedule
 Agencies to which the client has been referred
 Treatment, including ART and preventive treatment (CTX, INH), once initiated
 Assess for social issues such as client or family alcohol abuse, psychological or
mental health problems, family violence, joblessness or other possible factors that
could negatively influence adherence.
 Provide counseling and take-home leaflets (if available) on prevention for people
living with HIV as part of every visit (see SOP 21).
 Schedule routine follow-up:
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Create individual client record using HIV chronic care card based on WHO model
or national guidelines; record all findings
 Assign enrollment number or unique identification number
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
20
Figure 1:
Recommendations at a glance
Adolescent or adult living with HIV
CD4 testing / WHO clinical staging
of all patients
Eligible for ART:
CD4 count ≤350 cells/mm3 and/or
WHO stage 3 or 4
Ineligible for ART or unknown
eligibility:
 CD4 count >350 cells/mm3 OR
WHO stage 1 or 2
 Screen for OIs including TB and
HBV
 Screen for opportunistic infections
 Provision of counseling on positive
(OIs) including TB and HBV
infections
 Preparation for ART, including
history of previous exposure to
ARVs
Revised
recommended
ART
regimens for eligible adults and
adolescents living with HIV:
 AZT + 3TC + EFV
 AZT + 3TC + NVP
 TDF + 3TC/FTC + EFV
 TDF + 3TC/FTC + NVP
living
 Regular follow up appointments,
including WHO clinical staging, in
accordance with national
guidelines
 Repeat CD4 testing every six
months
 WHO clinical staging at every visit
 CTX and INH preventive therapy
as indicated according to national
guidelines
From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the
Primary Care Practitioner.
21
Table 3: Criteria for ART initiation in specific populations
Target population
Clinical condition
Recommendation
Asymptomatic individuals
(including pregnant women)
WHO clinical stage 1
Start ART if CD4 ≤350
WHO clinical stage 2
Start ART if CD4 ≤350
WHO clinical stage 3 or 4
Start ART irrespective of CD4
cell count
Active TB disease
Start ART irrespective of CD4
cell count
HBV infection requiring
treatment*
Start ART irrespective of CD4
cell count
Symptomatic individuals
(including pregnant women)
TB and hepatitis B
co infections
From: WHO Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a
public health approach 2010 revision.
Table 4: WHO clinical staging of HIV disease in adults and adolescents
Clinical stage 1
 Asymptomatic
 Persistent generalized lymphadenopathy
Clinical stage 2
 Moderate unexplained weight loss (under 10% of presumed or measured body
weight)
 Recurrent respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis)
 Herpes zoster
 Angular cheilitis
 Recurrent oral ulcerations
 Papular pruritic eruptions
 Seborrhoeic dermatitis
 Fungal nail infections
Clinical stage 3







Unexplained severe weight loss (over 10% of presumed or measured body weight)
Unexplained chronic diarrhea for longer than 1 month
Unexplained persistent fever (intermittent or constant for longer than 1 month)
Persistent oral candidiasis
Oral hairy leukoplakia
Pulmonary TB
Severe bacterial infections (e.g. pneumonia, empyema, meningitis, pyomyositis, bone
or joint infection, bacteraemia, severe pelvic inflammatory disease)
 Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
22
 Unexplained anemia (below 8 g/dl), neutropenia (below 0.5 x 109/l) and/or chronic
thrombocytopenia (below 50 x 109/l)
Clinical stage 4





















HIV wasting syndrome
Pneumocystis jiroveci pneumonia
Recurrent severe bacterial pneumonia
Chronic herpes simplex infection (orolabial, genital or anorectal of more than 1
month’s duration or visceral at any site)
Esophageal candidiasis (or candidiasis of trachea, bronchi or lungs)
Extrapulmonary TB
Kaposi sarcoma
Cytomegalovirus disease (retinitis or infection of other organs, excluding liver, spleen
and lymph nodes)
Central nervous system toxoplasmosis
HIV encephalopathy
Extrapulmonary cryptococcosis including meningitis
Disseminated nontuberculous mycobacteria infection
Progressive multifocal leukoencephalopathy
Chronic cryptosporidiosis
Chronic isosporiasis
Disseminated mycosis (histoplasmosis, coccidiomycosis)
Recurrent septicaemia (including nontyphoidal Salmonella)
Lymphoma (cerebral or B cell non-Hodgkin)
Invasive cervical carcinoma
Atypical disseminated leishmaniasis
Symptomatic HIV-associated nephropathy or HIV-associated cardiomyopathy
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
23
SOP 3: Clinical visit — clients not eligible for ART
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To conduct the initial assessment as part of a package of comprehensive HIV care,
treatment and support to newly enrolled patients. Much of the first clinical visit may
take place on the same day as the registration/enrollment visit if HIV diagnosis is
confirmed and clinic schedule allows.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, ARV, follow-up/default
register, etc) as per national guidelines
1. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
3. CTX, multivitamins
4. Counseling materials as teaching aids and for distribution to patients
5. TB screening form
6. Laboratory test referral request form if required
Procedure
Once clinical and laboratory assessment, staging of HIV disease, and
determination of eligibility for ART have taken place, continue with initial visit as
follows for patient categorized as not yet eligible for ART. This SOP is a direct
follow-on to SOP 2: Initial assessment visit to determine eligibility if patient is
determined to be non-eligible (SOP 2 content is not duplicated here).
24
 Greet client and re-emphasize confidentiality of HIV services.
 Provide pre-ART counseling:
 Discuss the reasons for determination of non-eligibility for ART at this time
 Explain that once ART is prescribed, it is for life
 Discuss the importance of attending all routine clinic appointments
 Discuss the importance of excellent adherence to preventive treatment (CTX,
INH) and ART, once initiated
 Explain that starting ART before an individual is ready may impact future
treatment options
 Briefly review concept of regular routine HIV monitoring, and explain types, rationale
and schedule for HIV care that will be provided until patient becomes ART eligible.
 Discuss importance of adherence to clinic visit schedule for physical exam, lab
updates, especially CD4 testing, and preventive treatment and care.
 Conduct comprehensive physical examination to assess for signs of HIV-related
conditions, complications, and other medical conditions:
 Female patients: conduct pelvic exam to screen for STIs (include RPR/VDRL lab
screening for syphilis) including genital/anal warts; screen for cervical cancer by
visual inspection once yearly if in accordance with national guidelines or defer
until second clinical visit, see SOPs 17 and 18
 Male patients: conduct a genital exam to assess for presence of circumcision,
STIs (include RPR/VDRL lab screening for syphilis), genital/anal warts, see SOP
17
 Order or conduct laboratory testing (or wait until ART eligibility is confirmed before
ordering laboratory profile), if consistent with national guidelines:
 Urinalysis
 Complete blood count blood chemistries including liver function test
 Conduct symptomatic screening for TB using national TB screening checklist; and
order TB laboratory confirmation if TB disease suspected.
 Assess immunization status and provide immunizations required according to
national guidelines.
 Initiate CTX prophylaxis in all HIV positive clients according to national guidelines
(see SOP 8).
 Provide mental health assessments (see SOPs 25, 26 and 27):
 Assess general mental status, including adjustment to HIV diagnosis, reaction to
non-eligibility for ART
 Screen for social issues such as client or family alcohol abuse, psychological or
mental health problems, family violence, joblessness or other possible factors that
25
could negatively influence adherence
 Provide mental health and support group referrals, as appropriate
 Review reproductive history:
 Discuss reproductive intentions
 Explain contraceptive options; provide or refer for additional contraceptive
method, if desired (see SOP 16)
 If planning a family, discuss safe conception
 Discuss safer sex, dispense condoms
 Conduct or refer for nutritional assessment and counseling (See SOP 22 nutritional
assessment).
 Recommend or dispense multivitamins, if available.
 Provide or refer for counseling to review elements of “positive living”:
 Avoidance of HIV transmission or re-infection by practicing safer sex and partner
notification and testing
 Personal hygiene (washing hands after using toilet or before preparing/eating
food, bathing daily, brushing teeth, etc)
 Nutrition and good food hygiene
 Provide counseling and take-home leaflets (if available) on prevention for people
living with HIV as part of every visit (see SOP 21).
 Explain concept of family centered HIV care and treatment and offer HIV testing for
family members and support for partner/family discussions.
 Schedule routine three-monthly follow-up:
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 If initial assessment was conducted before laboratory tests were returned, and the
laboratory work subsequently reveals that the client is eligible for ART; contact
him or her for immediate follow up, even if it is not yet time for the follow-up
appointment
 Record appointment in follow-up register
 Document:
 Record all findings and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
26
SOP 4: Clinical visit — clients eligible for ART
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To conduct the initial assessment as part of a package of comprehensive HIV care,
treatment and support to newly enrolled patients. The first clinical visit may take place
on the same day as the registration/enrollment visit if HIV diagnosis is confirmed and
clinic schedule allows.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, ARV, follow-up/default
register, etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. CTX, ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. TB screening form
7. Laboratory test referral request form if required
Procedure
Once clinical and laboratory assessment, staging of HIV disease, and
determination of eligibility for ART have taken place, continue with initial visit as
follows for patient categorized as eligible for ART. Eligibility for ART and
readiness to begin ART are not the same. This SOP is a direct follow-on to SOP
2: Initial assessment visit to determine eligibility if and when a patient is
27
determined to be eligible (SOP 2 content is not duplicated here).
4.1 Confirm eligibility for ART initiation
 Review patient records and confirm ART eligibility by physical examination, WHO
staging and laboratory criteria (CD4 count) according to national guidelines.
 Discuss with appropriate members of HIV team (counselors, social workers) to
determine if patient also meets social criteria for initiation of ART. Social criteria may
include:
 Residence in district where health facility is located
 An understanding of the importance of excellent adherence and risks of poor
adherence (see SOP 5)
 Expressed willingness to comply with visit schedule and treatment schedule
 Prior disclosure of HIV status to partner/family and availability of family/social
support to accompany client to clinic visits and/or assist with adherence to ART
 Prior experience with good adherence to CTX prophylaxis or other HIV-related
treatment if applicable
 Make final determination of treatment readiness and appropriateness of ART
initiation and document in patient record.
4.2 Provide routine HIV care for ART-eligible HIV patients in accordance with
National Guidelines
 Greet patient and reemphasize confidentiality of HIV services.
 Provide ART counseling:
 Explain reasons for determination of eligibility and treatment readiness
 Briefly review concept of regular routine HIV monitoring, and explain types,
rationale and schedule for HIV care that will be provided in addition to ART
 Explain need for more frequent clinic visits during first several months of ART to
check for side effects, drug toxicities, and to monitor adherence, according to
national protocol
 Re-emphasize importance of excellent adherence to ART and preventive
treatment (CTX, INH); provide or refer to counselor for additional ART adherence
counseling if required (See SOP 5)
 Discuss importance of adherence to clinic visit schedule for physical exam, lab
updates, especially CD4 testing, adherence checks, medication refills, and
preventive treatment and care. This is particularly important now that client is
about to begin treatment.
 Emphasize the importance of following up on referrals, where made
 Conduct directed medical history to determine progression of disease and care
provided since HIV diagnosis received.
28
 Conduct directed physical examination:
 Document vital signs, body mass index (BMI), and to assess for signs of HIVrelated conditions and complications, confirm previous WHO staging
 Screen both male and female patients for STIs (include rapid syphilis test to
screen for syphilis)
 Female patients: conduct pelvic exam to screen for STIs including genital/anal
warts; screen for cervical cancer by visual inspection once yearly if in accordance
with national guidelines or defer until second clinical visit
 Male patients: conduct a genital exam to assess for presence of circumcision,
STIs (include RPR/VDRL lab screening for syphilis), genital/anal warts
 Female patients: rule out pregnancy by history, pregnancy test and/or exam
 Provide treatment for conditions detected, according to national guidelines.
 Order or conduct laboratory testing, according to national guidelines, and document
in patient chart:
 Urinalysis
 Renal function
 Complete blood count blood chemistries including liver function test
 CD4 cell testing, if not conducted in the past three months; compare CD4 to
previous CD4 count(s) to gain an understanding of disease status
 Where available, baseline viral load
 Conduct symptomatic screening for TB using national TB screening checklist; and
order TB laboratory confirmation if TB disease suspected.
 Assess immunization status and provide immunizations required according to
national guidelines.
 Initiate CTX prophylaxis in HIV positive clients according to national guidelines (see
SOP 8).
 Provide mental health assessments (see SOPs 25, 26, and 27):
 Assess general mental status, including adjustment to HIV diagnosis, reaction to
eligibility for ART, likelihood of successful adherence and perceived barriers to
adherence
 Screen for social issues such as client or family alcohol abuse, psychological or
mental health problems, family violence, joblessness or other possible factors that
could negatively influence adherence
 Provide mental health and support group referrals, as appropriate
 Review reproductive history:
 Discuss reproductive intentions
29
 Explain contraceptive options; provide or refer for additional contraceptive
method, if desired (see SOP 16)
 If planning a family, discuss safe conception
 Discuss safer sex, dispense condoms
 Conduct or refer for nutritional assessment and counseling (see SOP 22 nutritional
assessment).
 Recommend or dispense multivitamins, if available.
 Write prescription and/or dispense initial ART medications (or defer ART in light of
contraindications, concurrent conditions or other factors encountered during initial
visit, in accordance with national guidelines), see SOP 6 for guidance on ART
regimen selection.
 If acute brain syndrome — secondary to HIV-associated encephalopathy, Stage 4
— or pregnancy, “Fast-track” to receive ART within 2 weeks–1 month of clinical
staging or as soon as possible
 If TB disease confirmed, initiate ART as soon as possible, preferably within 8
weeks of starting TB treatment
 Temporarily defer initiation of ART if:
 Poor level of understanding of ART and ART adherence
 Patient refusal to begin therapy
 Current alcohol or drug abuse severe enough to affect adherence
 All other patients should receive ART as soon as possible after clinical staging or
CD4 measurement that qualified them for ART initiation
 Describe and discuss potential side effects of ART and drug-drug interactions, how to
recognize, what to do if these occur.
 Notify clinic manager if not possible to initiate ART as above, to develop an
appropriate alternative.
 Provide or refer for counseling to review elements of “positive living”:
 Avoidance of HIV transmission or re-infection by practicing safer sex and partner
notification and testing
 Personal hygiene (washing hands after using toilet or before preparing/eating
food, bathing daily, brushing teeth, etc)
 Nutrition and good food hygiene
 Provide counseling and take-home leaflets (if available) on prevention for people
living with HIV as part of every visit (see SOP 21).
 Explain concept of family centered HIV care and treatment and offer HIV testing for
family members and support for partner/family discussions.
30
 Schedule routine three or six monthly follow-up
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Record all findings and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
31
Table 5: When to start ART
Target population
HIV+ asymptomatic
ARV-naive
individuals
2010 ART guideline
CD4 ≤350 cells/mm3
2006 ART guideline
CD4 ≤200 cells/mm3
WHO stage 2 or 3 and CD4 ≤200
cells/mm3
WHO clinical stage 2 if CD4
≤350 cells/mm3
HIV+ symptomatic
ARV-naive
individuals
OR
WHO clinical stage 3 or 4
irrespective of CD4 cell
count
CD4 ≤350 cells/mm3
irrespective of clinical
symptoms
HIV+ pregnant
women
OR
WHO clinical stage 3 or 4
irrespective of CD4 cell
count
HIV/TB co infection
ARV-naive
individuals
WHO stage 4 irrespective of CD4 cell
count
Consider treatment for WHO clinical
stage 3 and CD4 cell count between 200
and 350 cells/mm3
WHO stage 1 or 2 and
CD4 ≤200 cells/mm3
WHO stage 3 and CD4 ≤350 cells/ mm3
WHO stage 4 irrespective of CD4 count
Presence of active TB disease and CD4
≤350 cells/mm3
ART Initiation can be delayed if CD4
≥200 cells/mm3
No specific recommendation
Individuals who require
treatment for their HBV
infection*, irrespective of
CD4 cell count
The current diagnosis of chronic active hepatitis in well-resourced settings is based on
histological parameters obtained by liver biopsy and/or the availability of HBV DNA testing,
neither of which is usually available in resource-limited settings. A global definition of chronic
active hepatitis in the context of resource-limited settings based on clinical signs and simpler
laboratory parameters is under discussion.
HIV/HBV co
infection ARV-naive
individuals
*
Presence of active TB
disease, irrespective of CD4
cell count
WHO stage 3 if CD4 not available
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
32
Table 6: What ART to start
Target
population
2010 ART guideline
2006 ART guideline
 No change, but in settings where d4T
HIV+ ARVnaive adults and
adolescents


HIV+ pregnant
women


HIV/TB co
infection
HIV/HBV co
infection



regimens are used as the principal option for
starting ART a progressive plan to move
towards AZT-based or TDF-based first-line
regimens should be developed, based on an
assessment of cost and feasibility
AZT preferred but TDF acceptable
EFV included as a NNRTI option (but do not
initiate EFV during first trimester)
Benefits of NVP outweigh risks where CD4
count is 250−350 cells/mm3
In HIV+ women with prior exposure to MTCT
regimens
No change
ART should be initiated as soon as possible in
all HIV/TB-co infected patients with active TB
(within 8 weeks after the start of TB treatment)
NNRTI regimens that contain both TDF + 3TC
(or FTC) are required
AZT or TDF + 3TC (or
FTC) + EFV or NVP
AZT + 3TC + NVP
AZT or TDF + 3TC (or
FTC) + EFV
TDF + 3TC (or FTC) +
EFV
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
33
SOP 5: Treatment readiness and adherence counseling
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To determine ART treatment readiness and provide adherence counseling to adults
with HIV, as part of an integrated HIV service package.
Introduction:
 Adherence levels of 95% or greater have been shown to maximize effectiveness of
ART and minimize the development of drug resistance.
 Treatment readiness or pre-ART counseling requires 2–3 visits at least one week
apart to allow time to adjust to the reality of lifelong treatment and time to assess
coping with diagnosis and treatment realities. This also provides time for the patient
to build a relationship with their health-care team.
 Routine adherence monitoring visits after initiation of ART should be scheduled at 5–
7 days after initiation, every two weeks for the first two months, and every month
thereafter, coordinated with regular clinic visit whenever possible to improve
attendance.
 All members of the health-care team should be encouraged to ask about adherence
at every point of contact.
Responsibility
 Adherence counselors
 Triage nurses
 All levels of clinical staff
 Peer counselors, patient advocates, community support workers
Supplies
1. Counseling area that offers adequate privacy
2. Medical record and relevant registers (HIV client register, ARV, adherence register,
peer educator registers, follow-up/default register, etc) as per national guidelines
3. Equipment/supplies:
a. Adherence counseling monitoring forms and checklists
b. Adherence counseling materials for patients and family
c.
Rapid Adherence Assessment for triage nurse if applicable
34
d. Pill boxes, adherence calendars,
Procedure
Using adherence counseling skills and adherence counseling content that is
consistent with national guidelines:
5.1 Provide treatment readiness (pre-ART) counseling to assess readiness to
begin and maintain ART
 Greet client and introduce yourself.
 Explain the purpose of treatment readiness assessment(s).
 Review patient self-assessment of health status in presence of HIV diagnosis.
 Assess patient willingness to begin and continue lifelong ART.
 Assess knowledge and provide information:
 Assess patient overall knowledge of HIV disease
 Determine patient understanding of rationale and criteria for ART initiation
 Assess patient’s basic understanding of mechanism of action of ARVs
 Explain rationale and criteria for other prophylactic treatment such CTX and INH
 Discuss side effects/drug interactions:
 Describe and discuss possible side effects
 Explain the importance of early recognition of signs and symptoms of ART side
effects, adverse reactions and drug toxicities
 Explain possible interactions between ARVs and other HIV-related medications
patient is taking or may need to take
 Discuss non-HIV medications and beliefs in traditional cures for HIV, and explain
potential problems with use of certain non-HIV and traditional medicines while on
ART (potential interactions)
 Explain how to recognize signs/symptoms of drug-drug interactions
 Discuss adherence:
 Explain importance of taking all required actions to assure that the first ART
treatment regimen selected is effective for as long as possible to avoid
development of infections associated with immunosuppression, complications of
more complex treatment regimens, drug resistance
 Explain importance of continuing to take ARVs even when physical condition
improves
 Discuss the link between adherence, resistance, and future treatment options
35
 Explain that clients who adhere to their ARV regimen are much less likely to
transmit HIV to their sexual partners (but continue to strongly encourage and
support use of condoms)
 Explain the need to avoid erratic or interrupted ARV dosing
 Discuss drug-related factors influencing treatment adherence: pill burden,
complexity of dosage regimen, unpleasant tastes or other medication-associated
factors
 Explain the risks of discontinuing therapy and caution against it
 Discuss the risks of sharing medications and caution against it
 Assess ability and willingness to self-monitor and report adherence, with clinic or
family assistance if required
 Conduct assessment of well-being:
 Determine level of coping with HIV diagnosis and “comfort level” with need to
initiate treatment
 Discuss disclosure and social support: identify to whom patient has disclosed HIV
status
 Discuss stigma and discrimination, either perceived or actual, that patient fears or
has encountered
 Explain importance of “treatment adherence partner”; determine availability of
family and social support, identify specific individuals who might become
“treatment adherence partners” (see Table 7, below)
 Assess patient’s use of and reasons for traditional and non-HIV medications or
treatments, alcohol and other mood altering drugs
 Identify presence of specific factors known to be associated with poor adherence:
 Competing priorities — changes in social circumstances/employment
 Stress/depression
 New partners/non-disclosure
 Men living alone
 Alcohol use/abuse
 Develop an ART plan:
 Show patient the actual drugs in his/her ART regimen, review names of each ARV
and explain which medications to take at which times; ask patient to repeat
demonstration to you several times
 Agree on times that the patient will take their medication daily, and what
reminders will be used to assist with adherence
 Assess ability and willingness to fit medication schedule into daily life
36
 Assess ability to store medications safely and correctly
 Assess ability to adhere to visit schedule:
 Assess willingness and ability to maintain regular clinic visit schedule
 Identify potential difficulties with transportation for medication refill visits and/or
clinic visits and identify realistic solutions
 Assure method of regular communication between clinic visits, home visits and
ability to contact patient in case of default or loss to follow up
 Connect patient with any community resources that are available.
5.2 Once client has begun ART: assess and monitor adherence to ART regimen
 Review and update patient record and registration information.
 Discuss patient experience with ARV medications since last visit.
 Discuss any illnesses experienced since last visit.
 Identify any drug-associated problems such as side effects, adverse events.
 Reassure about availability of medications to address side effects and make referral
to clinical staff if required.
 Identify any use of traditional therapies or other medicines.
 Assess and discuss adherence:
 Assess level of adherence by 7-day patient self-report and compare with
information from adherence partner if available
 Verify patient-assessed adherence using one or more of several methods: Visual
Analogue Scale (VAS) Pill Identification Test (PIT), pill count, provide estimate,
pharmacy refill data, self-report (information on conducting the VAS, PIT, and pill
count can be found in Appendix A)
 Explore barriers to adherence, including alcohol and mood altering drugs and
discuss possible solutions
 Identify food and nutrition related factors to adherence (no food to take with ARVs
as prescribed)
 Discuss use of adherence tools: patient adherence diary, reminder cards or
calendars, pill boxes
 Identify mental health, depression, denial issues and plan referral for clinical
assessment if required.
 Compare clinical and laboratory status at last visit and at current visit to assess likely
signs of non-adherence (new infections, weight loss, significant change in lab
values).
 Emphasize importance of behaviors to prevent risk of transmission and minimize risk
37
of re-exposure or reinfection even while on ART and regardless of improved physical
health: safer sex, partner reduction, condom use, universal precautions and personal
hygiene.
 Special adherence support may be needed for:
 Initial weeks of combined TB- ART treatment
 Second-line ART regimens
 Patients experiencing adverse effects of treatment
 Co-morbidities or complex medical problems
 Difficult family or social situations
 Patients who live far away from the health facility
 Alcohol or drug use
 Psychiatric or neurolologic conditions
 Confer with social worker or triage nurse if indicated to coordinate treatment
adherence plan.
 Discuss with clinical staff or triage nurse if any significant clinical manifestations of
ART-related problems are identified.
 Schedule next treatment readiness/ adherence counseling appointment preferably on
same day as next medical appointment to facilitate attendance:
 If patient adherence verified, schedule next regular adherence visit according to
counseling protocol
 If patient non-adherent, but wants to continue ART, schedule visit within 48 hours
to reinforce today’s counseling content and request treatment adherence partner
also attend if possible
 Record appointment in follow-up register
 Document:
 Record all findings and discussions in patient record
 Complete adherence checklists, if available
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
38
Table 7: Treatment adherence partners
Support the use of treatment adherence partners
Definition
 A treatment adherence partner (“adherence buddy”) can be a partner, parent,
son/daughter, someone from support group, friend, neighbor, teacher, religious
advisor, etc. who is:
 Chosen by the patient
 Accepted the patient’s HIV-positive status
 Committed to support the patient with ART for a long time
 Available to participate in training sessions to be educated on HIV, ART, TB and
other opportunistic infections
 Available twice daily especially in the first months of therapy and after that as
necessary to support adherence
 Somebody who will maintain confidentiality
Prepare the treatment adherence partner
 Meet with the proposed adherence partner to explain requirements.
 Discuss primary responsibilities of an adherence partner:
 Remind client to take the medicine (and to work out with the patient how best to
do so)
 Attend all follow-up clinic appointments
 Attend appointments at agencies to which the client has been referred
 Discuss the need to provide the client with psychosocial support, help coping with
stigma and related issues in the community.
 Explain the concept and responsibility of confidentiality.
 Discuss “burn-out” and prepare for potential emotional needs of the treatment
adherence partner, him/herself.
 Explain how to reach the clinical team if urgent problems with the patient arise.
39
SOP 6: ART regimen selection
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide guidance on ART regimen selection and monitoring as part of an
integrated HIV service package. (Laboratory monitoring appears in SOP 7.)
Introduction
 There is wide variation in treatment protocols among countries, based on available
resources and local expert advice. Basic principles of treatment and monitoring can
be adapted by country programs to adhere to national treatment and monitoring
guidelines. (See also the section entitled “Illustrative examples of national
adaptations”.)
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 HIV specialist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, ARV, follow-up/default
register, etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. CTX, ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
40
Procedure
6.1 Review patient profile
 Assess patient profile and select recommended initial ART regimen considering
contraindications:
 Review all pertinent clinical information to assure accuracy, completeness and
ART eligibility
 Review counseling notes and assessment of ability to adhere to ART regimen
once initiated
 Review and update targeted history, physical findings and laboratory results
(including anemia, renal or hepatic function, reproductive status, see SOP 7)
 Review patient profile in light of global technical treatment recommendations (see
Table 8)
6.2 Start ART in eligible patients, according to national guidelines
 The best time to start ART, if possible, is before patients become sick or present with
an opportunistic infection.
 Start ART in all adolescents and adults, including pregnant women, with HIV who:
 Have CD4 count less than 350 cells/mm, whether or not clinical signs and
symptoms are present (i.e., even if they are in WHO Stage 1 or Stage 2) or
 Are in WHO Clinical Stage 3 or Stage 4 at ANY CD4 count, or if no CD4 is yet
available
6.3 Select appropriate initial regimen for ART-naïve patients
 Treatment-naïve patients should be started on ART as per country treatment
guidelines. It is typical to initiate ART using one non-nucleoside reverse
transcriptase inhibitor (NNRTI) in combination with two nucleoside reverse
transcriptase inhibitors (NRTI).
 Use fixed-dose combinations, if available, to reduce complexity of regimen and
maximize patient adherence.
 Do not use EFV during first trimester of pregnancy to avoid possible neural tube
defects. EFV can more safely be used after first trimester to replace NVP if required
due to NVP intolerance or contraindication.
 Treatment guidelines in Tables 9–13 (below) describe the most recent treatment
recommendations from both WHO and DHHS, but may suggest drugs that are not
yet available in some countries.
6.4 Monitor patients on ART
41
 Provide clinical monitoring for all ART patients according to national guidelines.
 Beginning with initiation of first-line ART (Day 0), usual schedule for ART clinical revisits includes:
 Revisit at 2 weeks, 4–6 weeks, 8–10 weeks, 12–14 weeks, every 3 months for the
first two years of ART
 After Year 2, visits can take place every 6 months, more frequently if
complications occur
 Adolescent patients should continue with visits every 3 months until age 18–20
years, depending on national protocol
 See SOP 15 for second- or third-line ART clinical re-visit schedule
 Every follow up clinical visit includes:
 Adherence assessment by an adherence care team. Clinical staff are informed if
adherence is determined to be less than 90%. Adherence assessment includes
determination of presence of specific factors known to be associated with poor
adherence (see SOP 5 Adherence)
 CTX prophylaxis, identification and treatment of OIs or other conditions, drug
toxicities, TB screening, INH preventive therapy if indicated, STI screening, pap
smear, pregnancy testing and family planning method review, immunization
update (see SOP 4 for full schedule and content of routine clinical visits)
 Review with patient, partner and family, if possible, the importance of adherence
to clinic visit schedule and drug regimens (ART, TB, and preventive treatments
such as CTX and INH, if initiated)
 Counseling on positive living
6.5 Recognize and manage interruption or discontinuation of ART
 Interruption or discontinuation of ART, whether required to manage medical
problems, intentional by patient, or unintentional due to supply outages, can
negatively affect treatment outcome as well as contribute to development of resistant
strains. Timely management according to national guidelines is key.
Recognize and manage required therapeutic interruption of ART:
 Review patient records to determine cause of required therapeutic treatment
interruption. These can include:
 Life-threatening drug toxicity such as Stevens-Johnson Syndrome or acute
fulminant hepatitis
 Inability to take medications orally due to acute illness
 Severe immune reconstitution syndrome (IRIS)
42
 TB coinfection causing drug intolerance interactions
 When possible, adjust rather than discontinue ART, since ART discontinuation may
result in:
 Rapid increase in HIV viral load
 Rapid decrease in CD4 cell count
 Increased risk of rapid clinical progression of HIV-related complications and
progression to AIDS
 Consider long half-life of EFV and NVP, and with exception of life-threatening toxicity,
stop EFV/NVP two weeks prior to discontinuing other medications.
 If NVP treatment is interrupted for longer than 2 weeks, when reintroducing, begin
with NVP 200 mg once daily and increase to NVP twice daily if single daily dose is
well tolerated.
 Consult senior clinician or HIV Specialist if available, to develop ART interruption
treatment plan.
Recognize and manage discontinuation of ART:
 Thoroughly review patient records and interview patient, partner, family to determine
possible causes of ART discontinuation. These can include:
 Patient or family-centered adherence issues (see SOP 5)
 Access issues: cost, distance, transport
 Necessary medical decisions such as intolerable side effects or toxicities with no
appropriate alternative regimen available, patient or family wishes to discontinue
therapy, or end stage HIV-related illness and can no longer comply with therapy
 If patient deliberately discontinued ART, request patient agreement to continue to
monitor clinically for OIs. Prior to re-initiation in same patient, conduct new baseline
clinical and laboratory assessment and new treatment readiness assessment.
 As with any routine and non-routine visit: provide counseling and take-home leaflets
in response to emerging needs (see SOP 21); inquire about partner, children and
other family members; review importance of clinic visit schedule and set date/time for
next appointment.
At all visits
 Schedule routine follow-up
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
43
 Record all findings and discussions in patient record
 ART enrollment form and record book
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
Table 8: Global technical treatment recommendations
Key 2010 technical treatment recommendations
 Revised WHO guidelines suggest progressive phase-out of stavudine (d4T) as part
of first-line regimen, using less toxic AZT or TDF instead.
 Do not use EFV during first trimester of pregnancy to avoid possible neural tube
defects. EFV can more safely be used after first trimester to replace NVP if required
due to NVP intolerance or contraindication.
 Avoid starting CTX prophylaxis and ART at the same time. Rash may occur with use
of either drug, so starting CTX prophylaxis before ART makes identification of cause
of rash easier.
 In TB-HIV coinfection, start anti TB drugs first, then ART as soon as possible within 8
weeks.
 Consider pharmacologic selection criteria:
 Therapeutic efficacy, cost, availability
 Minimal or manageable side effects
 Pill burden and ease of use
 Ease of storage (refrigeration etc) for facility and patient
 Requirement to take medication with food
 Drug/drug interactions, i.e. TB treatment, oral contraceptives
 Fertility plans
44
Table 9: Preferred first-line ART in treatment-naïve adults and adolescents
Target
population
Preferred options
Adults and
adolescents
AZT or TDF + 3TC or
FTC + EFV or NVP
Pregnant
women
AZT + 3TC + EFV or
NVP
HIV/TB co
infection
AZT or TDF + 3TC or
FTC + EFV
HIV/HBV co
infection
TDF + 3TC or FTC +
EFV or NVP
Comments
 Select the preferred regimens applicable to the








majority of PLHIV.
Use fixed-dose combinations.
Do not initiate EFV during first trimester.
TDF acceptable option.
In HIV women with prior exposure to PMTCT
regimens, see “Table 30: ART regimens
recommended for women with prior exposure to
PMTCT regimen”.
Initiate ART as soon as possible (within the first
8 weeks) after starting TB treatment.
NVP or triple NRTIs are acceptable options if
EFV cannot be used.
Consider HBsAg screening before starting ART,
especially when TDF is not the preferred firstline NRTI.
Use of two ARVs with anti-HBV activity required.
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
45
Table 10: Dosages of recommended ARVs
Generic name
Dose
Nucleoside reverse transcriptase inhibitors (NRTIs)
Abacavir (ABC)
300 mg twice daily or 600 mg once daily
Didanosine (ddI)
400 mg once daily (>60 kg) 250 mg once daily (≤60 kg)
Emtricitabine (FTC)
200 mg once daily
Lamivudine (3TC)
150 mg twice daily or 300 mg once daily
Stavudine (d4T)
30 mg twice daily
Zidovudine (AZT)
250−300 mg twice daily
Nucleotide reverse transcriptase inhibitors (NtRTIs)
Tenofovir
300 mg once daily1
Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Efavirenz (EFV)
600 mg once daily
Etravirine (ETV)
200 mg twice daily
Nevirapine (NVP)
200 mg once daily for 14 days, followed by 200 mg twice
daily2
Protease inhibitors (PIs)
Atazanavir + ritonavir (ATV/r)
300 mg + 100 mg once daily
Darunavir + ritonavir (DRV/r)
600 mg + 100 mg twice daily
Fos-amprenavir + ritonavir
(FPV/r)
700 mg + 100 mg twice daily
Indinavir + ritonavir (IDV/r)
800 mg + 100 mg twice daily
 Fixed Dose Combination tablets (LPV 200 mg / RTV 50
mg) Two tablets (400 mg/200 mg) twice daily3
 Considerations for individuals on TB therapy In the
presence of rifabutin, no dose adjustment required In the
Lopinavir/ritonavir (LPV/r)
presence of rifampicin; use ritonavir super boosting (LPV
400 mg + RTV 400 mg twice daily) or LPV 800 mg + RTV
200 mg twice daily, with close clinical and hepatic enzyme
monitoring
1 TDF dosage adjustment for individual with altered creatinine clearance can be considered
(using Cockcroft-Gault formula).
Creatinine clearance ≥50 ml/min, 300 mg once daily.
Creatinine clearance 30−49 ml/min, 300 mg every 48 hours.
Creatinine clearance ≥10−29ml/min (or dialysis), 300 mg once every 72−96 hours.
Cockcroft-Gault formula: GFR = (140-age) x (Wt in kg) x (0.85 if female) / (72 x Cr)
46
2
3
In the presence of rifampicin, or when patients switch from EFV to NVP, no need for lead-in
dose of NVP.
LPV/r can be administered as 4 tablets once daily ( i.e. LPV 800 mg + RTV 200 mg once
daily) in patients with less than three LPV resistance-associated mutations on genotypic
testing. Once-daily dosing is not recommended in pregnant women or patients with more
than three LPV resistance-associated mutations.
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
Table 11: Acceptable ARV regimens for treatment-naïve patients
Acceptable Regimens (CI): Regimens that may be selected for some patients but are less satisfactory
than preferred or alternative regimens, and Regimens that may be Acceptable but more definitive
data are needed (CIII).
NNRTI-Based Regimen
 EFV + ddI + (3TC or FTC) (CI)
PI-Based Regimens
 ATV + (ABC or AZT)/3TC1 (CI)
 DRV/r + (ABC or AZT)/3TC1 (CIII)
INSTI-Based Regimen
 RAL + (ABC or AZT)/3TC1 (CIII)
Comments
 EFV + ddI + (FTC or 3TC) has only been studied in
small clinical trials.
 ATV/r is generally preferred over ATV. Unboosted
ATV may be used when RTV boosting is not
possible.
 MVC: Tropism testing should be performed before
initiation of therapy;
CCR5 Antagonist-Based Regimens
 MVC + AZT/3TC1 (CI)
 MVC + TDF/FTC1 or ABC/3TC1
(CIII)
Regimens that may be acceptable but should be used with caution: Regimens that have
demonstrated virologic efficacy in some studies but have safety, resistance, or efficacy concerns (see
comments below).
NNRTI-Based Regimens
 NVP + ABC/3TC1 (CIII)
 NVP + TDF/FTC1 (CIII)
PI-Based Regimens
 FPV + [(ABC or AZT)/3TC1 or
TDF/FTC1] (CIII)
 SQV/r + TDF/FTC1 (CI)
 SQV/r + (ABC or AZT)/3TC1 (CIII)
Comments
Use NVP and ABC together with caution because
both can cause HSRs within first few weeks after
initiation of therapy.
Early virologic failure with high rates of resistance has
been reported in some patients receiving NVP + TDF
+ (3TC or FTC). Larger clinical trials are currently in
progress.
FPV/r is generally preferred over unboosted FPV.
Virologic failure with unboosted FPV-based regimen
may select mutations that confer cross-resistance to
DRV.
SQV/r
 •QV/r was associated with PR and QT prolongation
in a healthy volunteer study.
47
 Baseline ECG is recommended before initiation of
SQV/r.
 SQV/r is not recommended in patients with any of
the following:
 pretreatment QT interval >450 msec
 refractory hypokalemia or hypomagnesemia
 concomitant therapy with other drugs that
prolong QT interval
 complete AV block without implanted
pacemaker
 risk of complete AV block
1
3TC may be substituted with FTC or vice versa.
From: Panel on Antiretroviral Guidelines for adults and Adolescents. Guidelines for the use of ARV
agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS).
January 10, 2011; 1-166.
48
Table 12: ARV components not recommended as initial therapy
ARV Drugs or
Components (in
alphabetical order)
ABC/3TC/AZT (coformulated) as triple-NRTI
combination regimen (BI)
Reasons for NOT recommending as initial therapy
 Inferior virologic efficacy
ABC + 3TC + AZT + TDF as
quadruple-NRTI
combination (BI)
 Inferior virologic efficacy
ABC + ddI (BIII)
 Insufficient data in ART-naïve patients
ABC + TDF (BIII)
 Insufficient data in ART-naïve patients
DRV (unboosted)
 Use without RTV has not been studied
DLV (BII)
 Inferior virologic efficacy
 Inconvenient (three times daily) dosing
ddI + TDF (BII)




T-20 (BIII)
 No clinical trial experience in ART-naïve patients
 Requires twice-daily subcutaneous injections
ETR (BIII)
 Insufficient data in ART-naïve patients
IDV (unboosted) (BIII)
 Inconvenient dosing (three times daily with meal restrictions)
 Fluid requirement
IDV (RTV-boosted) (BIII)
 High incidence of nephrolithiasis
NFV (BI)
 Inferior virologic efficacy
 High incidence of diarrhea
RTV as sole PI (BIII)
 High pill burden
 Gastrointestinal intolerance
SQV (unboosted) (BI)
 Inferior virologic efficacy
High rate of early virologic failure
Rapid selection of resistance mutations
Potential for immunologic nonresponse/CD4 T-cell decline
Increased ddI drug exposure and toxicities
 Significant toxicities including lipoatrophy; peripheral
d4T + 3TC (BI)
TPV (ritonavir-boosted) (BI)
neuropathy; and hyperlactatemia, including symptomatic and
life-threatening lactic acidosis, hepatic steatosis, and
pancreatitis
 Inferior virologic efficacy
From: Panel on Antiretroviral Guidelines for adults and Adolescents. Guidelines for the use of ARV
agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS).
January 10, 2011; 1-166.
49
Table 13: ARV regimens or components that should not be offered at any time
Rationale
Exception
ARV regimens not recommended
 Rapid development of resistance
Monotherapy with
 Inferior ARV activity when
No exception
NRTI (AII)
compared with combination of
three or more ARV agents
Dual-NRTI regimens
(AI)
 Rapid development of resistance
 Inferior ARV activity when
No exception
compared with combination of
three or more ARV agents
 High rate of early virologic
nonresponse seen when tripleABC/AZT/3TC (BI) and
NRTI combinations, including
Triple-NRTI regimens
possibly TDF +
ABC/TDF/3TC and
(AI) except for
AZT/3TC (BII) in
TDF/ddI/3TC, were used as
ABC/AZT/3TC (BI) or
patients in whom other
initial regimen in ART-naïve
possibly TDF +
combinations are not
patients.
AZT/3TC (BII)
desirable
 Other triple-NRTI regimens have
not been evaluated.
ARV components not recommended as part of an ARV regimen
 Potential additive
ATV + IDV (AIII)
No exception
hyperbilirubinemia
ddI + d4T (AII)
 High incidence of toxicities:
peripheral neuropathy,
pancreatitis, and hyperlactatemia
 Reports of serious, even fatal,
cases of lactic acidosis with
hepatic steatosis with or without
pancreatitis in pregnant women
When no other ARV
options are available
and potential benefits
outweigh the risks (BIII)
ddI + TDF (AII)
 Increased ddI concentrations and
serious ddI-associated toxicities
 Potential for immunologic
nonresponse and/or CD4 cell
count decline
 High rate of early virologic failure
 Rapid selection of resistance
mutations at failure
Clinicians caring for
patients who are
clinically stable on
regimens containing
TDF + ddI should
consider altering the
NRTIs to avoid this
combination.
2-NNRTI combination
(AI)
 When EFV combined with NVP,
higher incidence of clinical
No exception
50
adverse events seen when
compared with either EFV- or
NVP-based regimen.
 Both EFV and NVP may induce
metabolism and may lead to
reductions in ETR exposure;
thus, they should not be used in
combination with ETR.
EFV in first trimester
 Teratogenic in nonhuman
of pregnancy or in
primates
women with
significant
childbearing potential
(AIII)
 Similar resistance profiles
FTC + 3TC (AIII)
 No potential benefit
When no other ARV
options are available
and potential benefits
outweigh the risks (BIII)
No exception
ETR + unboosted PI
(AII)
 ETR may induce metabolism of
these PIs; appropriate doses not
yet established
No exception
ETR + RTV-boosted
ATV or FPV (AII)
 ETR may alter the concentrations
of these PIs; appropriate doses
not yet established
No exception
ETR + RTV-boosted
TPV (AII)
 ETR concentration may be
significantly reduced by RTVboosted TPV
No exception
 NVP in ARV-naïve
women with:
 CD4 count >250
cells/mm3 or
men with
 CD4 count >400
cells/mm3 (BI)
 High incidence of symptomatic
hepatotoxicity
If no other ARV option
available; if used,
patient should be
closely monitored
d4T + AZT (AII)
Unboosted DRV,
SQV, or TPV (AII)
 Antagonistic effect on HIV-1
No exception
 Inadequate bioavailability
No exception
From: Panel on Antiretroviral Guidelines for adults and Adolescents. Guidelines for the use of ARV
agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS).
January 10, 2011; 1-166.
51
SOP 7: Conduct routine laboratory monitoring
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To conduct routine laboratory monitoring to support timely initiation and monitoring of
ART and HIV disease, as part of an integrated HIV service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 HIV specialist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers as per national guidelines
3. Laboratory test referral request form if required
Procedure
 Routine laboratory testing facilitates optimum therapeutic effect, rapid
identification/confirmation of significant or potentially life threatening side effects and
toxicities. However, ART can be initiated and continued without extensive laboratory
monitoring if no other options are available.
 Routine laboratory monitoring should be integrated into routine clinical visits (see
SOP 3, 4 and 6). Ensure that each clinical visit includes a routine review of
laboratory results received since the last visit and integration of these results into the
decision-making process.
 Routine lab monitoring of immunologic and virologic status of patients on first-line
ART is presented in Table 14.
 Additional lab monitoring to consider include the following:
 Initial CD4 and at 3 and 6 months, 1 year and 6 monthly thereafter at minimum to
monitor immunologic response to ART
 Viral load, if available at initiation, 6 months, 1 year and then yearly to monitor
virologic response to ART
 If available, order genotyping at baseline and as indicated by national guidelines
 Hemoglobin at 1 month, 3 months and 4–6 months if on AZT to rule out AZT52
related severe anemia; full blood count if symptoms/signs/labs indicate
 AST/ALT:
 If on NVP — at 2, 4 and 12 weeks and if rash or hepatic signs/symptoms
develop to identify NVP-related hepatic toxicity
 If on EFV — at 4 and 12 weeks
 Creatinine clearance test for all patients, if available, at:
 Baseline
 1 months, every 3–6 months
 Yearly
 Conduct creatinine clearance test for all patients on TDF-containing regimen to
screen for TDF-related renal toxicity
 Fasting total cholesterol and triglycerides at baseline and:
 If baseline is normal: repeat annually
 If baseline is abnormal: repeat every 6 months
 If on LPV/r: consider repeating every months
 Fasting blood glucose at baseline and:
 If baseline is normal: repeat every 6 months
 If baseline is abnormal: repeat every 3–6 months
 If patient is on a PI: repeat every 3–6 months
53
Table 14: Laboratory monitoring before, during and after initiating ART
Phase of HIV management
Recommended test
At HIV diagnosis
CD4
Pre-ART
CD4
Desirable test
HBsAg
CD4
Hb for AZT1
Creatinine clearance for TDF2
ALT for NVP3
On ART
CD4
Hb for AZT1
Creatinine clearance for TDF2
ALT for NVP3
At clinical failure
CD4
Viral load
At immunological failure
Viral load
Women exposed to PMTCT
interventions with sd-NVP with a
tail within 12 months and without a
tail within 6 months of initiating
ART
Viral load 6 months after
initiation of ART
At start of ART
1
2
3
Recommended test in patients with high risk of adverse events associated with AZT (low CD4 or
low BMI).
Recommended test in patients with high risk of adverse events associated with TDF (underlying
renal disease, older age group, low BMI, diabetes, hypertension and concomitant use of a boosted
PI or nephrotoxic drugs).
Recommended test in patients with high risk of adverse events associated with NVP (ART-naive
HIV+ women with CD4 of >250 cells/mm 3, HCV coinfection).
Patients who are not yet eligible for ART should have CD4 count measurement every six months and
more frequently as they approach the threshold to initiate ART. If feasible, HBsAg should be performed in
order to identify people with HIV/HBV coinfection and who, therefore, should initiate TDF-containing ART.
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
54
Ongoing Care and Management,
Including Treatment Failure
Background
Chemoprophylaxis
CTX prophylaxis (SOP 8) is a well-tolerated, cost-effective and lifesaving intervention
for PLHIV. Similarly, INH preventive therapy (SOP 9) is an important intervention for
preventing and reducing active TB in communities affected by HIV. INH preventive
therapy is safe in people taking ART — safer, in fact, than four-drug TB therapy. INH
preventive therapy and CTX prophylaxis should be part of the package of care delivered
by HIV service providers for people living with HIV and their families.
Management of common symptoms and coinfections (SOPs 10 and 11)
Minor signs and symptoms of opportunistic infections are often the first indication of
worsening immunologic status, especially in settings where CD4 testing is not available.
Patient visits for common HIV-related symptoms create an opportunity to provide
symptomatic relief, reassurance and patient education, and help improve quality of life
while living with HIV. Increased clinical vigilance to recognize early signs of OIs and
initiate timely treatment can prolong life and help improve quality of life in patients with
HIV.
Recognition of adverse events (SOP 12 and 13)
ARV medications can be responsible for a wide range of toxicities. Differentiating
between complications of HIV disease and ART toxicity (also known as adverse
reactions) is sometimes difficult. Alternative explanations for an observed toxicity could
include a concurrent infectious process (e.g. hepatitis A or malaria) or a reaction to
medications other than ARVs (e.g. INH-induced hepatitis in a client on treatment for TB
or a rash induced by CTX).
Drug-related adverse reactions while on ART can occur immediately (soon after the
drug has been administered), early (within the first days or weeks of treatment) or late
(after months or more of treatment). Adverse reactions can vary in severity from mild to
severe to life-threatening and may be specific to the drug or generic to the class of
drugs in use. The decision to substitute a new ARV or a new regimen depends on the
severity of the adverse reaction.
Toxicity can be monitored clinically and can also be assessed by a limited number of
laboratory tests — the specific tests depend on the ART regimen in use. Routine
monitoring is desirable, but not essential to treatment eligibility.
Switching regimens (SOPs 14 and 15)
Poor adherence, inadequate drug levels or prior existing drug resistance can all
55
contribute to ART failure. Always assess and address adherence issues, treat any
intercurrent infection, and exclude IRIS before switching therapies.
Use clinical criteria supported by immunological or virological confirmation, where
possible, to identify treatment failure. If CD4 testing is not available, decision-making on
switching to a second-line regimen is based on clinical criteria (new stage 3 or stage 4
events). When treatment failure is confirmed, it is necessary to switch to a second-line
regimen. This should not be confused with substitution of a single drug because of
toxicity.
Definitions
 Prophylaxis for opportunistic infections (OIs): Medication or treatment used to
prevent illness. For example, CTX is used to prevent many infections, including
PCP. Likewise, INH preventive therapy is used in eligible patients to prevent TB.
 TB exposure: An individual comes into close contact with an infectious TB patient.
The individual may have a positive tuberculin skin test, but a positive tuberculin skin
test is not necessary to prove exposure.
 TB infection: The individual inhales the aerosol droplet containing the TB organism.
TB infection is usually indicated by a positive tuberculin skin test; however, there are
limitations to the test. Clients with M. tuberculosis infection, but without active
disease, are not ill and do not have symptoms suspicious of TB.
 Treatment failure, failure to suppress viral replication with development of viral
resistance, can be clinical, immunologic or virologic. WHO defines treatment failure
as:
 Clinical failure:
 New or recurrent WHO stage 4 condition
 Certain WHO clinical stage 3 infections (e.g. pulmonary TB, severe bacterial
infection) after differentiating from IRIS
 Immunologic failure:
 Fall of CD4 count to baseline or below
 50% fall from on-treatment peak value
 Persistent CD4 levels below 100 cells/mm
 Virologic failure:
 Plasma viral load above 5000 copies/ml (repeated) after 6 months on ART

First line therapy: The ARV combination given at the beginning of treatment to an
individual who has never been treated previously for HIV.

Second line therapy: This refers to the combination of ARVs prescribed for a
person after the first line therapy fails (clinical and/or immunological progression of
disease despite good adherence to an effective ARV regimen. Second line therapy
will ideally include a minimum of three new drugs, with at least one from a new class,
56
in order to increase the likelihood of treatment success.
Policy
1. Individuals and families should be referred to other health services or community
services as needed. Care should be coordinated as much as possible in order to
reduce the burden of visits.
2. A chronic care model should be utilized so that patients and their families are seen
regularly and routinely for monitoring and health promotion activities as well as seen
for episodic care in the event of acute illness.
3. A multidisciplinary team approach should be utilized for the care of clients with HIV.
Teams may include a nurse, prescribing clinician, pharmacist, counselor, social
worker or others
Responsibility at health facility
 A single individual should be assigned at each health facility to establish and
supervise HIV care and treatment, including prescribing of ARVs and CTX; ensure all
services meet or exceed national policies, practices and guidelines; and to conduct
quality assurance measures.
 ART, CTX prophylaxis and other drugs should be prescribed by a physician, medical
or clinical officer or a nurse with training in HIV. Where possible this individual should
have the support of a multidisciplinary team that includes health workers that provide
counseling and support (which may be a nurse, counselor, social worker, peer
educator, or another trained professional) and pharmacist who is responsible for
dispensing medications. In health facilities staffed by a single professional, that
individual should be trained in HIV and able to fill all roles.
57
SOP 8: Provide CTX prophylaxis
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To decrease morbidity and mortality from common opportunistic diseases by
providing adults with CTX prophylaxis as part of an integrated HIV service package.
Introduction
 CTX is effective in preventing bacterial pneumonia, salmonella bacteremia,
pneumocystis jiroveci pneumonia (PCP), diarrhea (salmonella, cyclospora, isospora),
toxoplasmosis, and malaria.
 Evidence from resource-limited settings has shown that CTX can reduce
hospitalization, morbidity and mortality among people living with HIV, regardless of
whether or not they are on ART.
 CTX prophylaxis should be initiated as soon as possible if CD4 count is less than 350
cells/mm; or if patient is in WHO Stage 2, Stage 3, Stage 4 disease (regardless of
CD4 count); or at first adherence visit.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 Pharmacist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, ARV, follow-up/default
register, etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. CTX, ARV medications, multivitamins
58
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
 Review and update medical history including current HIV, non-HIV and traditional
medications, previous use of sulfa drugs, kidney or liver disease, previous reaction to
sulfa drugs.
 Determine if there is a documented past allergic reaction to sulfa drugs, including
Fansidar and CTX (CTX is also referred to as trimethoprim and sulfamethoxazole,
Septra, and Bactrim).
 Review lab results including most recent CD4 level.
 Order complete blood count as baseline.
 Conduct directed physical examination to identify signs of OIs or other HIV-related
infections; provide or refer for treatment, if required.
 Review or explain concept of opportunistic infections and benefits of CTX prophylaxis
to patient.
 Review signs and symptoms of sulfa allergy (maculopapular rash or severe skin
sloughing (Stevens Johnson Syndrome), anemia, fever, hepatitis.
 Explain importance of discontinuing or interrupting CTX if allergic response occurs.
 If no history of sulfa allergy or other contraindications, start CTX 160/800 mg once
daily (two single strength or one double strength tablet) at first adherence visit or as
soon as possible following HIV diagnosis in:
 All HIV positive adults with CD4 count below 350 (or as per national guidelines)
 All symptomatic HIV positive adults, that is patients with WHO Stage 2, Stage 3,
Stage 4 disease, regardless of CD4 count
 Patients with HIV/TB coinfection regardless of CD4 count, at least for duration of
TB treatment
 All pregnant women with HIV unless CD4 is greater than 350 and asymptomatic
 Do not give both CTX as prophylaxis and sulfadoxine-pyrimethamine (Fansidar)
malaria prophylaxis simultaneously
 If sulfa allergy is confirmed, substitute Dapsone 100 mg daily if available and
according to national protocol.
 Discontinue CTX prophylaxis if:
 ART therapy is initiated and CD4 level rises above 350 and remains high for 2
consecutive visits at least 6 months apart
 Serious side effects or signs of sulfa allergy occur
 If concurrent ART causes severe hepatic or renal insufficiency
59
 Grade 4 hypersensitivity reaction
 See Table 16
 Schedule routine three or six monthly follow-up:
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Record all findings and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
Table 15: Initiation of CTX prophylaxis among adults and adolescents living with
HIV
Based on who clinical staging criteria
alone (when CD4 count is not available)
WHO clinical stage 2, 3 or 4 [A-I]
Based on who clinical staging and
CD4cellcount criteria
Any WHO clinical stage and CD4< 350 cells per
mm3 b [A-III] OR WHO clinical stage 3 or 4
irrespective of CD4 level [A-I]
Universal option: Countries may choose to adopt universal CTX for everyone living with HIV and
any CD4 count or clinical stage. This strategy may be considered in settings with high
prevalence of HIV and limited health infrastructure [C-III].
From: World Health Organization, Department of HIV/AIDS. Guidelines on Co-trimoxazole prophylaxis for
HIV-related infections among children, adolescents and adults: recommendations for a public health
approach. Geneva 2006.
60
Table 16: Summary of recommendations for discontinuing primary CTX among
adults and adolescents
Target population
Recommendations
Do not discontinue CTX prophylaxis,
particularly in settings where bacterial
infections and malaria are common HIVrelated events [A-IV]
CD4 testing not available
(clinical assessment only)
Adults and
adolescents
living with HIV
Consider discontinuing CTX prophylaxis
among people with evidence of good clinical
response to ART (absence of clinical
symptoms after at least one year of therapy),
good adherence and secure access to ART
[C-IV]
In countries where CTX prophylaxis is
recommended only for preventing PCP and
toxoplasmosis, it can be discontinued among
those with evidence of immune recovery in
response to ART (CD4 >200 cells per mm3
CD4 testing available (clinical after at least six months of ART) [B-I]
and immunological
In countries with a high incidence of bacterial
assessment)
infections and malaria, discontinue CTX
prophylaxis among people with evidence of
immune recovery related to ART (CD4 >350
cells per mm3 after at least six months of ART)
[C-IV]
From: World Health Organization, Department of HIV/AIDS. Guidelines on Co-trimoxazole prophylaxis for
HIV-related infections among children, adolescents and adults: recommendations for a public health
approach. Geneva 2006.
When adapting these SOPs, this table should be replaced by a similar table from the national guidelines.
61
Table 17: CTX toxicity grading scale for adults and adolescents
Toxicity
Clinical description
Recommendation
Erythema
 Continue CTX prophylaxis with careful
and repeated observation and follow-up.
 Provide symptomatic treatment, such as
antihistamines, if available
Diffuse maculopapular rash,
dry desquamation
 Continue CTX prophylaxis with careful
and repeated observation and follow-up.
 Provide symptomatic treatment, such as
antihistamines, if available
GRADE 3
Vesiculation, mucosal
ulceration
 CTX should be discontinued until the
adverse effect has completely resolved
(usually two weeks), and then
reintroduction or desensitization can be
considered
GRADE 4
Exfoliative dermatitis, StevensJohnson syndrome or
erythema multiforme, moist
desquamation
 CTX should be permanently
discontinued
GRADE 1
GRADE 2
From: World Health Organization, Department of HIV/AIDS. Guidelines on Co-trimoxazole prophylaxis for
HIV-related infections among children, adolescents and adults: recommendations for a public health
approach. Geneva 2006.
62
SOP 9: Provide INH preventive therapy
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To decrease morbidity and mortality from TB by providing adults with INH preventive
therapy as part of an integrated HIV service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 Pharmacist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (INH, follow-up/default register, etc) as per
national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. INH, pyridoxine, ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
9.1 All HIV-infected clients are eligible for INH preventive therapy unless
contraindicated. Screen all HIV positive clients for active TB disease or INH
preventive therapy eligibility at every clinic visit
 Rule out active TB disease according to national TB/HIV protocol.
 If active TB disease diagnosed, refer on-site or to closest source of TB treatment,
63
document referral.
 See Figure 2, below.
 Note: All healthcare facilities must have in place infection control measures to
prevent transmission of TB in the healthcare setting (See Table 19).
9.2 If there is no indication of active TB, determine INH preventive therapy
eligibility and dispense
 Order baseline lab tests including full blood count, LFTs (bilirubin, ALT/AST) if
available.
 Review benefits of INH preventive therapy with patient and reinforce need for
adherence.
 Discuss side effects of INH including anorexia, nausea, abdominal or joint pain.
Suggest taking INH at night to minimize side effects.
 Explain need to stop taking INH and return to clinic promptly if serious side effects
occur (severe itching or skin rash, dizziness, confusion, convulsions, vomiting,
jaundice, dark color urine, or icterus).
 Advise patients who drink alcohol to stop or reduce intake while on INH preventive
therapy and provide rationale.
 Dispense or prescribe:
 INH 300 mg daily for 6–9 months either self-administered or DOT according to
HIV/TB national protocol
 Pyridoxine 50 mg daily to avert peripheral neuropathy often associated with INH
treatment; increase to 100 mg daily if neuropathy persists
 Use caution and routinely monitor if administering INH with d4T or ddI due to
increased risk of peripheral neuropathy.
 Schedule monthly monitoring and medication resupply visit.
 Refer for additional adherence counseling or community follow up if indicated.
 See Figure 3, below.
9.3 Complete INH preventive therapy treatment course (6–9 months)
 Congratulate patient on successful adherence and INH preventive therapy
completion.
 Continue to screen for active TB disease at every clinic visit.
 If active TB disease diagnosed, refer on-site or to closest source of TB treatment;
document referral.
 Conduct routine clinical visit as per SOP 3 or SOP 4.
64
At all TB-related visits:
 Schedule routine follow-up (monthly if still on INH preventive therapy):
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Record all findings and discussions in patient record, including date INH was
started
 Enter date INH was started in adherence follow-up book
 Complete all relevant as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
65
Figure 2:
Algorithm for diagnosis of TB in ambulatory HIV-positive patient
Ambulatory patient with cough 2–3 weeks and no danger signs
st
1 Visit
AFB HIV test
HIV+ or status unknown
AFB-positive
AFB-negative
2
nd
Visit
 Treat for TB
 CPT
 HIV assessment
TB likely
 CXR
 Sputnum AFB and
culture
 Clinical assessment
TB unlikely
rd
3 Visit
 Treat for PCP
 HIV assessment
th
4 Visit
Response
 Treat for bacterial
infection
 HIV assessment
 CPT
No or partial response
TB unlikely
Reassess for TB
From: Phase 1 Toolkit: Understanding the Revised WHO Recommendations and Supporting Their
Adaptation into National Guidelines Elizabeth Glaser Pediatric AIDS foundation (EGPAF). Washington,
DC (May 2010).
66
Figure 3: Algorithm for TB screening in adults and adolescents living with HIV in
HIV-prevalent and resource-constrained settings
Adults and adolescents living with HIV*
Screen for TB with any one of the following symptoms:**
Current cough
Fever
Weight loss
Night sweats
NO
Assess for contraindications
to INH preventive therapy***
NO
Give INH
preventive
therapy
YES
Defer INH
preventive
therapy
YES
Investigate for TB and
other diseases****
Other
diagnosis
Not TB
TB
Treat and
consider INH
preventive
therapy
Follow up and
consider INH
preventive
therapy
Treat
for TB
Screen for TB regularly at each encounter with a health worker or visit to
a health facility
Footnotes
*
Every adult and adolescent should be evaluated for eligibility to receive ART. Infection control
measures should be prioritized to reduce M. tuberculosis transmission in all settings that provide
care.
**
Chest radiography can be done if available, but is not required to classify patients into TB and nonTB groups. In high HIV-prevalence settings with a high TB prevalence among people living with
HIV (e.g. greater than 10%), strong consideration must be given to adding other sensitive
investigations.
***
Contraindications include: active hepatitis (acute or chronic), regular and heavy alcohol
consumption, and symptoms of peripheral neuropathy. Past history of TB and current pregnancy
should not be contraindications for starting INH preventive therapy. Although not a requirement for
initiating INH preventive therapy, tuberculin skin test may be done as a part of eligibility screening
in some settings.
**** Investigations for TB should be done in accordance with existing national guidelines.
From : WHO, Dept of HIV/AIDS. Guidelines for intensified tuberculosis case finding and isoniazid
preventive therapy for people living with HIV in resource constrained settings. World Health Organization.
2011
67
SOP 10: Management of common symptoms and
complications of HIV
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To manage the common symptoms and complications of HIV and AIDS experienced
by adults with HIV, as part of an integrated HIV service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, ARV, follow-up/default
register, etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. Essential medications to treat HIV-related illnesses according to national formulary,
ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
 Review patient records and progression of clinical and laboratory findings since HIV
diagnosis.
 Conduct directed medical history focused on patient-perceived changes in health
status, and signs and symptoms of possible HIV-related illnesses. Common signs
and symptoms of possible HIV-related illnesses include:
68
 Weight loss/wasting, fever, persistent generalized lymphadenopathy, persistent
cough, anemia, diarrhea, rash, dermatitis, pruritis, lesions, white exudates either
oral, pharyngeal, esophageal or vaginal, headache or other persistent pain,
neuropathy, altered mental status, anorexia, depression
 Discuss with patient any possible medication side effects or toxicities. See SOP 12.
 Determine or update WHO Stage of HIV disease.
 Based on history and exam, conduct or order appropriate laboratory tests to assist in
identification of HIV-related illnesses including:
 Complete blood count and hemoglobin, blood glucose, serum creatinine,
ALT/AST, TB and STI screen, sputum for AFB, stool culture or blood culture,
microscopy or culture to identify fungal organisms
 Treat symptomatically or with appropriate medication according to national protocol.
 Explain diagnosis and treatment regimen to patient and family, if present.
 Reassure about probable resolution of symptoms with treatment.
 Consult with team members either in the clinic or at a distance if difficult diagnostic
profile.
 As with any routine and non-routine visit: re-assess for social issues that could
negatively influence adherence; provide counseling and take-home leaflets in
response to emerging needs (see SOP 21); inquire about partner, children and other
family members; review importance of clinic visit schedule and set date/time for next
appointment.
Annual physical examination
In addition to the directed physical exam at every follow-up visit (to identify/confirm
signs and symptoms of possible HIV-related illnesses), all patients should be provided
with a complete physical examination yearly.
 Schedule next clinic visit to assess resolution of symptoms:
 Advise sooner return to clinic if signs and symptoms do not resolve or reoccur
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
 For additional information:
 See Table 18. The large number of signs and symptoms of complications
according to WHO clinical staging and the details involved in recognizing and
69
managing them, make it easier to present the information in tables rather than
narrative text. Country-specific modifications in treatment recommendations will
be required to reflect individual national guidelines
Appendices
 Appendix B: Clinical algorithms
Table 18: Diagnostic criteria for staging of HIV-related clinical events
Clinical event
Clinical stage 1
Clinical diagnosis
Definitive diagnosis
Asymptomatic
No HIV-related symptoms reported and no
signs on examination
Not applicable
Persistent generalized
lymphadenopathy
Painless enlarged lymph nodes >1 cm, in
two or more noncontiguous sites (excluding
inguinal), in absence of known cause and
persisting for 3 months or longer
Histology
Clinical stage 2
Moderate unexplained
weight loss (under 10%
of body weight)
Reported unexplained weight loss. In
pregnancy, failure to gain weight
Documented weight
loss (under 10% of
body weight)
Recurrent bacterial
upper respiratory tract
infections (current
event plus one or more
in last 6 months)
Symptoms complex, e.g. unilateral face
pain with nasal discharge (sinusitis), painful
inflamed eardrum (otitis media), or
tonsillopharyngitis without features of viral
infection (e.g. coryza, cough)
Laboratory studies if
available, e.g. culture of
suitable body fluid
Herpes zoster
Painful vesicular rash in dermatomal
distribution of a nerve supply does not
cross midline
Clinical diagnosis
Angular cheilitis
Splits or cracks at the angle of the mouth
not attributable to iron or vitamin deficiency,
and usually responding to antifungal
treatment
Clinical diagnosis
Recurrent oral
ulcerations (two or
more episodes in last 6
months)
Aphthous ulceration, typically painful with a
halo of inflammation and a yellow-grey
pseudo membrane
Clinical diagnosis
Papular pruritic
eruption
Papular pruritic lesions, often with marked
post inflammatory pigmentation
Clinical diagnosis
Seborrhoeic dermatitis
Itchy scaly skin condition, particularly
affecting hairy areas (scalp, axillae, upper
trunk and groin)
Clinical diagnosis
Fungal nail infections
Paronychia (painful red and swollen nail
bed) or onycholysis (separation of nail from
Fungal culture of nail /
nail plate material
70
Clinical event
Clinical diagnosis
nail bed) of the fingernails (white
discoloration, especially involving proximal
part of nail plate, with thickening and
separation of nail from nail bed)
Definitive diagnosis
Clinical stage 3
Severe unexplained
weight loss (more than
10% of body weight)
Unexplained chronic
diarrhea for longer than
1 month
Unexplained persistent
fever (intermittent or
constant and lasting for
longer than 1 month)
Reported unexplained weight loss (over
10% of body weight) and visible thinning of
face, waist and extremities with obvious
wasting or body mass index below 18.5. In
pregnancy, weight loss may be masked.
Documented loss of
more than 10% of body
weight
Chronic diarrhea (loose or watery stools
three or more times daily) reported for
longer than 1 month
Not required but
confirmed if three or
more stools observed
and documented as
unformed, and two or
more stool tests reveal
no pathogens
Reports of fever or night sweats for more
than 1 month, either intermittent or constant
with reported lack of response to antibiotics
or anti malarials, without other obvious foci
of disease reported or found on
examination. Malaria must be excluded in
malarious areas.
Documented fever
exceeding 37.6oC with
negative blood culture,
negative Ziehl-Nielsen
stain, negative malaria
slide, normal or
unchanged CXR and no
other obvious focus of
infection
Oral candidiasis
Persistent or recurring creamy white curdlike plaques which can be scraped off
(pseudo membranous), or red patches on
tongue, palate or lining of mouth, usually
painful or tender (erythematous form)
Clinical diagnosis
Oral hairy leukoplakia
Fine white small linear or corrugated
lesions on lateral borders of the tongue,
which do not scrape off
Clinical diagnosis
Pulmonary TB
Chronic symptoms (lasting at least 2 to 3
weeks): cough, haemoptysis, shortness of
breath, chest pain, weight loss, fever, night
sweats, plus EITHER positive sputum
smear OR negative sputum smear AND
compatible chest radiograph (including but
not restricted to upper lobe infiltrates,
cavitation, pulmonary fibrosis and
shrinkage). No evidence of extra pulmonary
disease.
Isolation of M.
tuberculosis on sputum
culture or histology of
lung biopsy (together
with compatible
symptoms)
Severe bacterial
infection (e.g.
Fever accompanied by specific symptoms
or signs that localize infection, and
Isolation of bacteria
from appropriate clinical
71
Clinical event
pneumonia, meningitis,
empyema, pyomyositis,
bone or joint infection,
bacteraemia, severe
pelvic inflammatory
disease)
Clinical diagnosis
response to appropriate antibiotic
Acute necrotizing
ulcerative stomatitis,
gingivitis or
periodontitis
Severe pain, ulcerated gingival papillae,
loosening of teeth, spontaneous bleeding,
bad odor, rapid loss of bone and/or soft
tissue
Clinical diagnosis
No presumptive clinical diagnosis
Diagnosed on
laboratory testing and
not explained by other
non-HIV conditions. Not
responding to standard
therapy with
haematinics, anti
malarials or
anthelmintics as
outlined in relevant
national treatment
guidelines, WHO IMCI
guidelines or other
relevant guidelines.
Unexplained anaemia
(below 8g/dl),
neutropenia (below 0.5
x 109/l) and/or chronic
(more than 1 month)
thrombocytopenia
(under 50 x 109/l)
Definitive diagnosis
specimens (usually
sterile sites)
Clinical stage 4
HIV wasting syndrome
Reported unexplained weight loss (over
10% of body weight) with obvious wasting
or body mass index below 18.5, plus
EITHER unexplained chronic diarrhea
(loose or watery stools three or more times
daily) reported for longer than 1 month OR
reports of fever or night sweats for more
than 1 month without other cause and lack
of response to antibiotics or anti malarials.
Malaria must be excluded in malarious
areas.
Documented weight
loss (over 10% of body
weight) plus two or
more unformed stools
negative for pathogens
OR documented
temperature exceeding
37.6°C with no other
cause of disease,
negative blood culture,
negative malaria slide
and normal or
unchanged CXR
Pneumocystis
pneumonia
Dyspnoea on exertion or nonproductive
cough of recent onset (within the past 3
months), tachypnoea and fever; AND CXR
evidence of diffuse bilateral interstitial
infiltrates, AND no evidence of bacterial
pneumonia. Bilateral crepitations on
auscultation with or without reduced air
entry.
Cytology or
immunofluorescent
microscopy of induced
sputum or
bronchoalveolar lavage
(BAL), or histology of
lung tissue
Recurrent bacterial
Current episode plus one or more episodes
Positive culture or
72
Clinical event
pneumonia (this
episode plus one or
more episodes in last 6
months)
Clinical diagnosis
in last 6 months. Acute onset (under 2
weeks) of symptoms (e.g. fever, cough,
dyspnoea, and chest pain) PLUS new
consolidation on clinical examination or
CXR. Response to antibiotics.
Definitive diagnosis
antigen test of a
compatible organism
Chronic herpes simplex
virus (HSV) infection
(orolabial, genital or
anorectal) of more than
1 month, or visceral at
any site or any duration
Painful, progressive anogenital or orolabial
ulceration; lesions caused by recurrent
HSV infection and reported for more than
one month. History of previous episodes.
Visceral HSV requires definitive diagnosis.
Positive culture or DNA
(by PCR) of HSV or
compatible
cytology/histology
Oesophageal
candidiasis
Recent onset of retrosternal pain or
difficulty in swallowing (food and fluids)
together with oral candidiasis
Macroscopic
appearance at
endoscopy or
bronchoscopy, or by
microscopy/histology
Extra pulmonary TB
Systemic illness (e.g. fever, night sweats,
weakness and weight loss). Other evidence
for extra pulmonary or disseminated TB
varies by site: pleural, pericardial,
peritoneal involvement, meningitis,
mediastinal or abdominal
lymphadenopathy, osteitis. Miliary TB:
diffuse uniformly distributed small miliary
shadows or micro nodules on CXR.
Discrete cervical lymph node M. TB
infection is usually considered a less
severe form of extra pulmonary TB.
M. tuberculosis isolation
or compatible histology
from appropriate site,
together with
compatible symptoms/
signs (if culture/
histology is from
respiratory specimen
there must be other
evidence of extra
pulmonary disease)
Typical appearance in skin or oropharynx
of persistent, initially flat patches with a
pink or blood-bruise color, skin lesions that
usually develop into violaceous plaques or
nodules
Macroscopic
appearance at
endoscopy or
bronchoscopy, or by
histology
Cytomegalovirus
disease (retinitis or
infection of other
organs, excluding liver,
spleen and lymph
nodes)
Retinitis only: may be diagnosed by
experienced clinicians. Typical eye lesions
on fundoscopic examination: discrete
patches of retinal whitening with distinct
borders, spreading centrifugally, often
following blood vessels, associated with
retinal vasculitis, haemorrhage and
necrosis.
Compatible histology or
CMV demonstrated in
CSF by culture or DNA
(by PCR)
CNS toxoplasmosis
Recent onset of a focal neurological
abnormality or reduced level of
consciousness AND response within 10
days to specific therapy.
Positive serum
toxoplasma antibody
AND (if available)
single/multiple
Kaposi sarcoma
73
Clinical event
Clinical diagnosis
Definitive diagnosis
intracranial mass lesion
on neuroimaging (CT or
MRI)
HIV encephalopathy
Clinical finding of disabling cognitive and/or
motor dysfunction interfering with activities
of daily living, progressing over weeks or
months in the absence of a concurrent
illness or condition, other than HIV
infection, which might explain the findings
Diagnosis of exclusion,
and, if available,
neuroimaging (CT or
MRI)
Extra pulmonary
cryptococcosis
(including meningitis)
Meningitis: usually sub-acute, fever with
increasingly severe headache, meningism,
confusion, behavioral changes that respond
to cryptococcal therapy
Isolation of
Cryptococcus
neoformans from extra
pulmonary site or
positive cryptococcal
antigen test on
CSF/blood
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
74
SOP 11: Management of common HIV-associated
coinfections
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To manage common HIV-associated opportunistic infections and coinfections
experienced by adults with HIV, as part of an integrated HIV service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 HIV Specialist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, follow-up/default register,
etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. Essential medications to treat opportunistic infections and coinfections according to
national formulary, ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
11.1 Overview of procedure for most HIV-associated opportunistic infections and
coinfections
 Review patient records and progression of clinical and laboratory findings since HIV
diagnosis to identify previous coinfections.
75
 Conduct directed medical history focused on patient-perceived changes in health
status, and signs and symptoms of possible coinfections.
 Conduct directed physical exam to identify/confirm signs and symptoms of possible
coinfections.
 Determine or update WHO Stage of HIV disease.
 Based on history and exam, conduct or order appropriate laboratory tests to assist in
identification of coinfection including:
 Complete blood count and hemoglobin, liver function and renal function blood
tests, CXR, sputum for AFB and culture, TB screen
 Treat with appropriate medication according to national protocol, or refer if required.
For Hepatitis see 10.2, below; for TB, see 10.3, below.
 Explain diagnosis and treatment regimen to patient and family, if present.
 Reassure about probable resolution with treatment.
 Consult with additional clinical staff if difficult diagnostic profile.
 As with any routine and non-routine visit: re-assess for social issues that could
negatively influence adherence; provide counseling and take-home leaflets in
response to emerging needs (see SOP 21); inquire about partner, children and other
family members; review importance of clinic visit schedule and set date/time for next
appointment.
 Two of the most common coinfections are TB/HIV and Hepatitis B/HIV.
11.2 Hepatitis B/HIV coinfection
 If patient has Hepatitis B/HIV coinfection and requires treatment for their Hepatitis B
regardless of CD4 cell count or WHO HIV clinical stage, s/he should be initiated on a
regimen containing both Tenofovir (TDF) and lamivudine (3TC) except in case of
severe side effects.
 TDF 300 mg QD + 3TC 150 mg twice a day + EFV 600 mg QD
 Monitor AST/ALT closely — TDF has been associated with life-threatening flare-ups
of hepatitis.
11.3 TB/HIV coinfection
 Among people living with HIV, TB is the most frequent life-threatening opportunistic
infection and a leading cause of death. At every clinical encounter, implement the
three I's strategy to prevent, detect and treat TB/HIV confection:
 INH preventive therapy where indicated
 Intensified case finding (ICF) for active TB
 TB infection control: TB infection control for facilities is summarized in Table 19,
76
below
 Refer for household and contact tracing for TB (assess family members, neighbors,
household).
All visits
 Schedule next clinic visit:
 Advise sooner return to clinic if signs and symptoms do not resolve or reoccur
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
Appendices
 Appendix B: Clinical algorithms
77
Table 19: Measures for facility-level TB infection control
Facility-level measures
1. Implement the set of facility-level managerial activities:
a) Identify and strengthen local coordinating bodies for TB infection control, and
develop a facility plan (including human resources, and policies and procedures
to ensure proper implementation of the controls listed below) for implementation.
b) Rethink the use of available spaces and consider renovation of existing facilities
or construction of new ones to optimize implementation of controls.
c) Conduct on-site surveillance of TB disease among health workers and assess
the facility.
d) Address advocacy, communication and social mobilization for health workers,
patients and visitors.
e) Monitor and evaluate the set of TB infection control measures.
f) Participate in research efforts.
Administrative controlsa
2. Promptly identify people with TB symptoms (triage), separate infectious patients,
control the spread of pathogens (cough etiquette and respiratory hygiene) and
minimize time spent in health-care facilities.
3. Provide a package of prevention and care interventions for health workers, including
HIV prevention, ART and INH preventive therapy for HIV-positive health workers.
Environmental controls
4. Use ventilation systems.
5. Use ultraviolet germicidal irradiation (UVGI) fixtures, at least when adequate
ventilation cannot be achieved.
Personal protective equipment
6. Use particulate respirators.
a
Administrative controls include (in addition to the items listed above) reduction of diagnostic delays,
use of rapid diagnostic tests, reduction of turnaround time for sputum testing and culture, and prompt
initiation of treatment.
From: WHO policy on TB infection control in health-care facilities, congregate settings and households,
2009
78
SOP 12: Recognition of adverse events and ART toxicity
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To recognize early and manage side effects, adverse events and ART toxicity in
adults with HIV as part of pharmacologic vigilance in an integrated HIV service
package.
Introduction
 Pharmacovigilance — a key element of ART monitoring — is to prevent, identify,
address and report adverse events or other possible drug-related problems to
maximize adherence, patient safety and health outcomes (WHO 2010). Extreme
watchfulness is important during the first six months of ART, especially in patients
started on ART when already seriously immuno-compromised.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 Pharmacist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (adverse event register, follow-up/default
register, etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. CTX, INH, pyridoxine, medications for symptomatic management of drug side
effects, ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
79
Procedure
12.1 Recognize early and manage side effects, adverse events and ART toxicity
 Review patient records and progression of clinical and laboratory findings since HIV
since HIV diagnosis.
 Conduct directed medical history focused on experience with ART and other HIV,
non-HIV and traditional medications since last visit, patient-perceived changes in
health status, symptoms of possible side effects or toxicities, and adherence.
 Discuss patient concerns about treatment, health status or other events since last
visit.
 Conduct directed physical exam to identify/confirm signs and symptoms of possible
side effects or toxicities, and adherence. Identify physical signs of lipodystrophy.
 Based on history and exam, conduct or order appropriate laboratory tests to confirm
suspicion of medication side effect, adverse event or toxicity.
 If HIV medication-related problem confirmed, classify severity of side effect, adverse
event or toxicity.
 If symptoms are mild Grade 1: headache, mild gastric upset, appetite or sleep
changes, fatigue:
 Reassure patient, provide medications for symptomatic relief, suggest return visit
within 1–2 weeks to reassess symptoms
 Do not discontinue medications
 If symptoms are moderate to severe, Grade 2: nausea and vomiting, severe
headache, mild peripheral neuropathy:
 Treat with appropriate medications (antiemetics, antidiarrheals, analgesics,
neuroleptics) as per national protocol or refer for appropriate care if required,
suggest reasonable return visit date to reassess symptoms
 Do not discontinue medications
 If symptoms are severe Grade 3–4: severe anemia, dehydration due to severe
vomiting, lactic acidosis, serious skin eruptions, severe headaches, severe hepatic or
renal changes, pancreatitis, lipodystrophy, insulin resistance:
 Review drug regimen, discontinue current medication(s) as indicated and
determine drug regimen change required according to national protocol and
availability, in consultation with HIV specialist if appropriate
 If ARVs are being discontinued, discontinue all medications in regimen to avoid
resistance related to single-drug interruption with the exception of NNRTIs
 Refer for additional treatment and care if required
 See Tables 20, 21, 22 and 23, below.
80
Severe anemia and lactic acidosis require drug modification/discontinuation and
hospital admission.
 Review with patient — and family, if present — any therapeutic changes made,
changes in dosage or timing of administration.
 Provide or refer for additional adherence or other counseling if required.
 As with any routine and non-routine visit: re-assess for social issues that could
negatively influence adherence; provide counseling and take-home leaflets in
response to emerging needs (see SOP 21); inquire about partner, children and other
family members; review importance of clinic visit schedule and set date/time for next
appointment.
 Schedule repeat visit within 1–2 weeks to reassess effect of medical intervention or
regimen change:
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Record all findings and discussions in patient record
 Complete all relevant registers (HIV client register, ARV, follow-up/default
register, etc) as per national guidelines
 If appropriate, complete ART adverse event register and national forms for
upward adverse event reporting (see 11.2, below)
 Complete paperwork for laboratory tests or other referrals, if applicable
12.2 Record adverse events in a central register
 Record in an adverse event register (or other clinic record) individual patient events
severe enough to result in:
 Change in therapy
 Cessation of ART
 Significant disability or death
 Include in the register:
 Age and sex of patient
 Drug history including date drug was started and the date adverse events started
 Drug suspected of causing toxicity
 Type and severity of adverse reaction
81
 And outcome of treatment change(s) instituted
 Report and discuss with ministry of health officials at next supervisory visit, or
according to national protocol.
 Modify clinic procedures if required.
 If a HIV Specialist Review Committee is available, report confirmed severe adverse
events and drug toxicities and clinical management to the Review Committee and
upward authorities according to national protocol.
 Ensure that reporting of adverse events is included as part of supportive supervision
or other clinic performance improvement activities.
Table 20: Grading of selected clinical and laboratory toxicities
Mild
Grade 1
Estimating Severity Grade
Clinical adverse
Symptoms causing
event NOT identified no or minimal
elsewhere in the
interference with
table
usual social and
functional activities
Haemoglobin
Absolute neutrophil
count
Platelets
Hyperglycaemia
(nonfasting and no
prior diabetes)
Triglycerides
Creatinine
AST (SGOT)
ALT (SGPT)
Severe
Grade 3
Potentially LifeThreatening
Grade 4
Symptoms causing
greater than
minimal interference
with usual social
and functional
activities
Symptoms causing
inability to perform
usual social and
functional activities
7.0−7.9 g/dl OR
70−79 g/l OR
4.31−4.92 mmol/l
750−999/mm3 OR
0.75−0.99/G/l*
50000−74999/mm3
OR 50−74.9/G/l*
6.5−6.9 g/dl OR
65−69 g/l OR
4.03−4.30 mmol/l
500−749/mm3 OR
0.5− 0.749/G/l*
20000−49999/ mm3
OR 20−49.9/ G/l*
>1.5−2.5 x ULN
126−250 mg/dl
>2.5−5 x ULN
251−500mg/dl
>5 x ULN
>500 mg/dl
55−64 mg/dl OR
3.01−3.55 mmol/l
116−160 mg/dl OR
6.44−8.90 mmol/l
40−54 mg/dl OR
2.19−3.00 mmol/l
161−250 mg/dl OR
8.91−13.88 mmol/l
30−39 mg/dl OR
1.67−2.18 mmol/l
251−500 mg/dl OR
13.89−27.76 mmol/l
<30 mg/dl OR <1.67
mmol/l
>500 mg/dl OR
>27.76 mmol/l
−
400−750 mg/dl OR
4.52−8.47 mmol/l
>1.5−3.0 x ULN
>2.5−5.0 x ULN
>2.5−5.0 x ULN
751−1200 mg/dl OR
8.48−13.55 mmol/l
>3.0−6.0 x ULN
>5.0−10.0 x ULN
>5.0−10.0 x ULN
>1200 mg/dl OR
>13.55 mmol/l
>6.0 x ULN
>10.0 x ULN
>10.0 x ULN
8.0−9.4 g/dl OR
80−94 g/l OR
4.93−5.83 mmol/l
1000−1500/mm 3
OR 1.0−1.5/G/l*
75000–99000/mm3
OR 75−99/G/l*
Chemistries
Hyperbilirubinaemia >1.0−1.5 x ULN
Glucose (fasting)
110−125 mg/dl
Hypoglycaemia
Moderate
Grade 2
>1.0−1.5 x ULN
1.25−2.5 x ULN
1.25−2.5 x ULN
Symptoms causing
inability to perform
basic self-care OR
medical or operative
intervention
indicated to prevent
permanent
impairment,
persistent disability
or death
<6.5 g/dl OR <65 g/l
OR <4.03 mmol/l
<500/mm3 OR
<0.5/G/l*
<20000/mm 3 OR
<20/G/l*
82
Gamma-glutamyl
transpeptidase
(GGT)
Alkaline
phosphatase
Bilirubin
Amylase
Pancreatic amylase
Lactate
Gastrointestinal
Nausea
Mild
Grade 1
1.25−2.5 x ULN
Moderate
Grade 2
>2.5−5.0 x ULN
Severe
Grade 3
>5.0−10.0 x ULN
Potentially LifeThreatening
Grade 4
>10.0 x ULN
1.25−2.5 x ULN
>2.5−5.0 x ULN
>5.0−10.0 x ULN
>10.0 x ULN
1.1−1.5 X ULN
>1.0−1.5 x ULN
>1.0−1.5 x ULN
<2.0 x ULN without
acidosis
1.6−2.5 x ULN
>1.5−2.0 x ULN
>1.5−2.0 x ULN
>2.0 x ULN without
acidosis
2.6−5.0 x ULN
>2.0−5.0 x ULN
>2.0−5.0 x ULN
Increased lactate
with pH <7.3 without
life-threatening
consequences
>5 x ULN
>5.0 x ULN
>5.0 x ULN
Increased lactate
with pH <7.3 with
life-threatening
consequences
Mild OR transient;
reasonable intake
maintained
Moderate
discomfort OR
intake decreased for
<3 days
Moderate OR
persistent; 4−5
episodes per day
OR vomiting lasting
>1 week
Severe discomfort
OR minimal intake
for >3 days
Hospitalization
required
Vomiting
Mild OR transient;
2−3 episodes per
day OR mild
vomiting lasting <1
week
Severe vomiting of
all foods/fluids in 24
hours OR
orthostatic
hypotension OR
intravenous Rx
required
Moderate OR
Bloody diarrhea OR
persistent; 5−7
orthostatic
loose stools per day hypotension OR >7
OR diarrhea lasting loose stools/day OR
>1 week
intravenous Rx
required
Hypotensive shock
OR hospitalization
for intravenous Rx
required
Diarrhoea
Mild OR transient;
3−4 loose stools
per day OR mild
diarrhea lasting <1
week
Dyspnoea on
exertion
Dyspnoea with
normal activity
Dyspnoea at rest
Dyspnoea requiring
O2 therapy
2+ or 3+
1 g to 2 g loss/ day
OR 0.3% to 1.0%
OR 3 g to 10 g/l
Gross, no clots
4+
2 g to 3.5 g loss/day
OR >1.0% OR >10
g/l
Gross plus clots
Nephrotic syndrome
Nephrotic syndrome
OR >3.5 g loss/day
Gross haematuria
1+
200 mg to 1 g loss/
day OR <0.3% OR
<3 g/l
Microscopic only
Miscellaneous
Fever (oral, >12
hours)
37.7−38.5 0C OR
100.0−101.5 0F
38.6−39.5 0C OR
101.6−102.9 0F
39.6−40.5 0C OR
103−105 0F
>40.5 0C OR >105
0F for ≥12
continuous hours
Intractable
Respiratory
Dyspnoea
Urinalysis
Proteinuria
Spot urine
24-hour urine
Mild; no Rx required Moderate OR nonnarcotic analgesia
Rx
Severe OR
responds to initial
narcotic Rx
Hypotensive shock
OR hospitalization
required
Obstructive
83
Allergic reaction
Mild
Grade 1
Pruritus without
rash
Rash
hypersensitivity
Erythema, pruritus
Fatigue
Normal activity
reduced by <25%
Moderate
Grade 2
Localized urticaria
Severe
Grade 3
Generalized
urticaria,
angioedema
Diffuse
Vesiculation OR
maculopapular rash moist desquamation
OR dry
OR ulceration
desquamation
Potentially LifeThreatening
Grade 4
Anaphylaxis
ANY ONE OF:
mucous membrane
involvement,
suspected StevensJohnson (TEN),
erythema
multiforme,
exfoliative
dermatitis
Unable to care for
self
Normal activity
Normal activity
reduced by 25−50% reduced by >50%;
cannot work
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
NOTE: There is a Grade 5 toxicity, which is death.
For abnormalities not found elsewhere in the toxicity table, use the information on Estimating severity
grade in the first column.
84
Table 21: Toxicities and recommended drug substitutions
ARV drug
TDF
AZT
EFV
NVP
ATV/r
Common associated toxicity
 Asthenia, headache, diarrhea, nausea,
vomiting, flatulence
 Renal insufficiency, Fanconi syndrome
 Osteomalacia
 Decrease in bone mineral density
 Severe acute exacerbation of hepatitis
may occur in HBV-coinfected patients
who discontinue TDF
 Bone marrow suppression: macrocytic
anaemia or neutropaenia
 Gastrointestinal intolerance, headache,
insomnia, asthenia
 Skin and nail pigmentation
 Lactic acidosis with hepatic steatosis
 Hypersensitivity reaction
 Stevens-Johnson syndrome
 Rash
 Hepatic toxicity
 Persistent and severe CNS toxicity
(depression, confusion)
 Hyperlipidaemia
 Male gynaecomastia
 Potential teratogenicity (first trimester of
pregnancy or women not using adequate
contraception)
 Hypersensitivity reaction
 Stevens-Johnson syndrome
 Rash
 Hepatic toxicity
 Hyperlipidaemia
 Indirect hyperbilirubinaemia
 Clinical jaundice
 Prolonged PR interval — first degree
symptomatic AV block in some patients
 Hyperglycaemia
 Fat maldistribution
 Possible increased bleeding episodes in
individuals with haemophilia
Suggested substitute
 If used in first-line
therapy AZT (or d4T if no
other choice)
 If used in second-line
therapy
 Within a public health
approach, there is no
option if patient has
failed AZT/d4T in firstline therapy. If feasible,
consider referral to a
higher level of care
where individualized
therapy may be available
 If used in first-line
therapy TDF (or d4T if no
other choice)
 If used in second-line
therapy d4T
 NVP
 bPI if intolerant to both
NNRTIs
 Triple NRTI if no other
choice
 EFV
 bPI if intolerant to both
NNRTIs
 Triple NRTI if no other
choice
 LPV/r
85
LPV/r
 Nephrolithiasis
 GI intolerance, nausea, vomiting,
diarrhea
 Asthenia
 Hyperlipidaemia (especially
hypertriglyceridaemia)
 Elevated serum transaminases
 Hyperglycaemia
 Fat maldistribution
 Possible increased bleeding episodes in
patients with hemophilia
 PR interval prolongation
 QT interval prolongation and torsade de
pointes
 ATV/r
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
86
Table 22: ARV-related adverse events and recommendations
Adverse events
Dyslipidaemia
Major first-line ARVs
 All NRTIs
(particularly d4T)
 EFV
Anemia and
neutropaenia
 AZT
Hepatitis
 All ARVs
(particularly NVP)
Lactic acidosis
 All NRTIs
(particularly d4T)
Lipoatrophy and
lipodystrophy
 All NRTIs
(particularly d4T)
Neuropsychiatric
changes
 EFV
Renal toxicity
(renal tubular
dysfunction)
 TDF
Peripheral
neuropathy
 d4T
Recommendations
 Consider replacing the suspected ARV.
 If severe (Hb <7.0 g/dl and/or ANC
<750 cells/ mm3), replace with an ARV
with minimal or no bone marrow toxicity
(e.g. d4T or TDF) and consider blood
transfusion.
 If ALT is at more than five times the
basal level, discontinue ART and
monitor. After resolution, restart ART,
replacing the causative drug (e.g., EFV
replaces NVP).
 Discontinue ART and refer. If severe
give supportive treatment.
 After resolution, resume ART with TDF.
 Early replacement of the suspected
ARV drug (e.g. d4T for TDF or AZT).
 Usually self-limited, without the need to
discontinue ART.
 If intolerable to the patient, replace
NVP with EFV or bPI. Single
substitution recommended without
cessation of ART.
 Dose adjustments according to
creatinine clearance of ART and CTX.
 Consider substitution with AZT.
 Replacement of d4T with AZT, TDF.
Symptomatic treatment (amitriptyline,
vitamin B6).
Adapted from: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision.
87
Table 23: Symptom-directed toxicity management
Adverse events
Acute pancreatitis
Drug eruptions
(mild to severe,
including StevensJohnson syndrome
or toxic epidermal
necrolysis)
Major firstline ARVs
 d4T
 NVP, EFV
(less
commonly)
Recommendations
 Discontinue ART. Give supportive treatment with
laboratory monitoring. Resume ART with an NRTI
with low pancreatic toxicity risk, such as AZT or TDF.
 In mild cases, symptomatic care. EFV rash often
stops spontaneously after 3−5 days without need to
change ART. If moderate rash, non-progressing and
without mucosal involvement or systemic signs,
consider a single NNRTI substitution (i.e. from NVP to
EFV). In moderate and severe cases, discontinue
ART and give supportive treatment. After resolution,
resume ART with a bPI-based regimen or triple NRTI
if no other choice.
 All NRTIs
Dyslipidaemia
(particularl
y d4T)
 EFV
 Consider replacing the suspected ARV.
 If severe (Hb <7.0 g/dl and/or ANC <750 cells/ mm3),
Anemia and
neutropaenia
 AZT
 All ARVs
Hepatitis
(particularl
y NVP)
 All NRTIs
Lactic acidosis
Lipoatrophy and
lipodystrophy
(particularly
d4T)
 All NRTIs
(particularl
y d4T)
replace with an ARV with minimal or no bone marrow
toxicity (e.g. d4T or TDF) and consider blood
transfusion.
 If ALT is at more than five times the basal level,
discontinue ART and monitor. After resolution, restart
ART, replacing the causative drug (e.g. EFV replaces
NVP).
 Discontinue ART and give supportive treatment. After
resolution, resume ART with TDF.
 Early replacement of the suspected ARV drug (e.g.
d4T for TDF or AZT).
 Usually self-limited, without the need to discontinue
Neuropsychiatric
changes
 EFV
Renal toxicity (renal
tubular dysfunction)
 TDF
Peripheral
neuropathy
 d4T
ART.
 If intolerable to the patient, replace NVP with EFV or
bPI. Single substitution recommended without
cessation of ART.
 Consider substitution with AZT and dose adjustment
of ARV drugs according to creatinine clearance.
 Replacement of d4T with AZT, TDF.
 Symptomatic treatment (amitriptyline, vitamin B6).
Adapted from: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision.
88
SOP 13: Recognition of treatment failure and when to switch
ART regimens
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 Purpose/Scope: To recognize treatment failure early and initiate timely, appropriate
switch of ART regimen in adults with HIV, as part of pharmacologic vigilance in an
integrated HIV service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 Pharmacist
 HIV Specialist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (Clinic treatment failure register, ART
complications register, d4T register, HIV client register, follow-up/default register,
etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. CTX, INH, pyridoxine, ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
Diagnose treatment failure in a timely manner (within a week after abnormal results
identified) and manage within available resources and according to national protocol:
89
 Review patient records and progression of clinical and laboratory findings.
 Conduct directed medical history to assess any possible symptoms or signs of
treatment failure.
 Conduct directed physical exam with focus on signs of OIs or other HIV-related
infections, or other indications of treatment failure.
 Conduct or order laboratory tests, if required, to confirm clinical impressions.
 Discuss with patient to determine possible adherence challenges or treatment
discontinuation — even temporary treatment interruption can be a potential
contributing factor to treatment failure (See SOP 5 Adherence for more on assessing
adherence and reasons for non-adherence).
 Utilize adherence confirmation methodologies including pill count, pharmacy refill
data, patient-perceived barriers to adherence with drug regimen or visit schedule
 Cross-check adherence information with patient’s adherence support person if
available (partner, family member, friend)
 If patient has discontinued treatment, it is important to address and resolve reasons
for discontinuation of ART (or sub-optimal adherence, or loss to follow up/default)
when modifying or restarting drug treatment.
 Review lab results as soon as possible after receipt — within 1 week if possible.
 Ensure that patient receives results and is counseled.
 Initiate required regimen changes within 1 month maximum.
 If treatment failure confirmed, in accordance with national guidelines:
 Select appropriate new regimen
 Counsel patient on reasons for change in regimen, differences in drug dosage,
timing of administration
 Review possible side effects of ARVs in new regimen with client/adherence
partner
 Schedule more frequent clinic visits (every 2 weeks if feasible) until efficacy of
new regimen and adherence reestablished
 Make note in record to repeat viral load (if available) six weeks after treatment
change
 Consult with HIV Specialist if there are any unresolved issues or need to confer
on treatment plan
 As with any routine and non-routine visit: re-assess for social issues that could
negatively influence adherence; provide counseling and take-home leaflets in
response to emerging needs (see SOP 21); inquire about partner, children and
other family members; review importance of clinic visit schedule and set date/time
for next appointment
90
 Schedule next clinic visit:
 Advise sooner return to clinic if signs and symptoms do not resolve or reoccur
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
 Record all findings in clinic treatment failure register
Table 24: ART switching criteria
Failure
Definition
Comments
 Condition must be differentiated
from immune reconstitution
inflammatory syndrome (IRIS)
 Certain WHO clinical stage 3
conditions (e.g. pulmonary TB,
severe bacterial infections), may
be an indication of treatment
failure
Clinical failure
 New or recurrent WHO
stage 4 condition
Immunological
failure
 Fall of CD4 count to
baseline (or below) OR
 50% fall from on-treatment
peak value OR
 Persistent CD4 levels
below 100 cells/mm3
 Without concomitant infection to
cause transient CD4 cell decrease
 Plasma viral load above
5000 copies/ml after 6
months on ART
 The optimal viral load threshold for
defining virological failure has not
been determined. Values of >5
000 copies/ml are associated with
clinical progression and a decline
in the CD4 cell count
Virological
failure
Adapted from: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision.
91
Figure 4:
Targeted viral load strategy for failure and switching
Suspected clinical or
immunological failure
Test viral load
VL > 5,000
copies/ml
Adherence intervention
Repeat VL
VL  5,000
copies/ml
VL > 5,000
copies/ml
Do not switch to second line
Switch to second line
VL = viral load
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
92
Figure 5:
Routine viral load strategy for failure and switching
Routine Viral Load
Testing
(not a prerequisite for
initiating ART)
VL > 5,000
copies/ml
Adherence intervention
Repeat VL
VL  5,000
copies/ml
VL > 5,000
copies/ml
Do not switch to second line
Switch to second line
VL = viral load
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
93
SOP 14: Switching to second-line ART regimens
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide timely and appropriate changes in ART when initial treatment failure is
diagnosed in adults with HIV, as part of pharmacologic vigilance in an integrated HIV
service package.
Introduction
 Treatment failure, failure to suppress viral replication with development of viral
resistance, can be clinical, immunologic or virologic. Treatment failure should only be
diagnosed after a minimum of 6 months of ART. Common criteria use viral load
greater than 5,000 copies/mL on two occasions, despite intensive adherence
counseling.
 Two common scenarios are:
 1) Early switching based on availability of viral load to detect failure
 2) Late switching based on less sensitive monitoring using clinical and
immunological criteria to define failure.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 Pharmacist
 HIV Specialist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (treatment failure register, ART complications
register, d4T register, HIV client register, follow-up/default register, etc) as per
national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
94
e. Paper examination drapes
f.
Disposable exam gloves
4. ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
14.1 Recognize need to switch from first-line to second-line ART regimen and
implement switch in a timely manner (within one month after treatment failure
confirmed) and within available resources, according to national protocol
 Review patient records to confirm accurate diagnosis of treatment failure and rule out
poor adherence as contributing factor:
 Conduct or update directed medical history and directed physical exam to confirm
symptoms, signs and timing of first-line regimen treatment failure
 Review CD4, viral load and other lab results that led to diagnosis of treatment
failure, and conduct or order priority additional laboratory tests (CD4, viral load), if
required, to confirm diagnosis
 Discuss in depth with patient, and partner/family, possible non-adherence or
discontinuation as potential contributing factor to treatment failure.
 It is important to address and resolve reasons for non-adherence or discontinuation,
if applicable. Adherence problems may continue on second-line ARVs, if cause is
not resolved (See SOP 5 for details on assessing/addressing adherence).
 Criteria for switching to second-line ART include:
 Clinical signs/symptoms
 Immunologic criteria (CD4) to confirm clinical failure when available
 Where available, confirm treatment failure with viral load (viral load above 5,000
copies on two separate occasions). Note: capacity for viral load testing may be
limited in Foundation-supported settings
14.2 When treatment failure is confirmed, select appropriate second-line regimen
 Select appropriate new regimen considering the following principles:
 A boosted protease inhibitor (PI/r or bPI) plus two nucleoside analogues (NRTIs)
are recommended for second-line ART
 Atazanavir/ritonavir (ATV/r) and lopinavir/ritonavir (LPV/r) are the preferred
boosted PIs for second-line ART
 Simplification of second NRTI option:
 If d4T or AZT used in first-line, switch to tenofovir + lamivudine or emtricitibine
95
(TDF+ 3TC or TDF + FTC)
 If TDF used in first-line, switch to zidovudine + lamivudine (AZT + 3TC) as the
NRTI backbone for second-line regimen
 Initiate required regimen changes within 1 month maximum.
 Consultation with HIV specialist is no longer required for straightforward switch to
second-line regimen. However, in patients with immunologic or clinical failure in the
presence of complete viral suppression, consult HIV specialist if possible.
 Counsel patient on reasons for change in regimen, differences in drug types,
dosages, timing of administration.
 Review possible side effects of ARVs in new regimen with client/adherence partner.
 As with any routine and non-routine visit: re-assess for social issues that could
negatively influence adherence; provide counseling and take-home leaflets in
response to emerging needs (see SOP 21); inquire about partner, children and other
family members; review importance of clinic visit schedule and set date/time for next
appointment.
 See Tables 24 (above) and Table 25 (below).
14.3 Conduct routine clinical and laboratory monitoring of patients switched to
second-line regimen
 Order and review CD4:
 At start of second-line regimen
 At 3 months and at 6 months after treatment change
 At 1 year after switch
 Yearly if virologic suppression achieved
 Conduct or order viral load:
 At 6 weeks after treatment change
 At 6 months and then every 12 months
14.4 Educate patient about risks associated with d4T
 Discuss signs and symptoms of d4T toxicity with patients on d4T-containing
regimens, and request prompt notification if these recur.
96
Phase out of d4T
 In 2010 WHO recommended that stavudine (d4T) be phased out of first-line
therapy regimens and replaced by either tenofovir (TDF) or zidovudine (AZT). Use
of d4T is associated with increased risk of lipoatrophy, peripheral neuropathy, lactic
acidosis, and pancreatitis. Although d4T use has declined significantly, WHO
estimates that in 2008, d4T was still part of the treatment regimen of 56% of adults
on ART in low- and middle-income countries.
 d4T use is expected to be progressively reduced by:
 1) Gradually replacing d4T, beginning with patients with actual clinical toxicity
 2) Using initial regimens that do not contain d4T (for all new patients starting
ART), where feasible
14.4 Transition from d4T (see Figure 6)
 Review patient record to assess for risk factors associated with specific d4T
toxicities:
 Peripheral neuropathy associated with older age (over 35 years)
 Lipodystrophy and hyperlactatemia are associated with BMI greater than 25 and
female gender
 Hyperlactatemia in women weighing more than 60 kg who gained weight rapidly
after d4T (at least 6 kg during first six months of initiation of d4T- containing ART
regimen)
 Conduct physical examination to identify physical signs of toxicity (lipodystrophy,
peripheral neuropathy).
 Order appropriate laboratory tests to diagnose/confirm d4T toxicity:
 Hyperlactatemia (lactate levels 5 mmol/L= hyperlactatemia)
 If d4T is continued, use 30 mg twice a day according to current WHO
recommendations; switch as soon as feasible.
 Do not re-start treatment with d4T if stopped secondary to severe lactate elevation.
 Review benefits of new regimen with patient and family, discuss importance of
adherence.
 Refer to adherence counselor for additional adherence information if required.
 See Table 26.
 Schedule more frequent clinic visits (every 2 weeks if feasible) until efficacy of new
regimen and adherence reestablished:
 Advise sooner return to clinic if signs and symptoms do not resolve or reoccur
 Record appointment in follow-up register
97
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete ART enrollment form, ART treatment failure forms
 Complete paperwork for laboratory tests or other referrals, if applicable
Table 25: Preferred second-line ART options
Target population
If d4T or AZT
used in firstAdults and
line therapy
adolescents
(including
If TDF used
pregnant
in first-line
women)
therapy
If rifabutin
available
Preferred options
 TDF + 3TC or FTC + ATV/r
or LPVr
 AZT + 3TC + ATV/r or
LPVr
 Same regimens as
recommended above for
adults and adolescents
Comments
 NRTI sequencing based on
availability of FDCs and
potential for retained antiviral
activity, considering early and
late switch scenarios
 ATV/r and LPVr are
comparable and available as
heat-stable FDCs or copackage formulations
 No difference in efficacy
between rifabutin and
rifampicin
 Rifabutin has significantly less
drug interaction with bPIs,
permitting standard bPI
dosing
 Same NRTI backbones as
TB/HIV co
infection
If rifabutin not
available
recommended for adults
and adolescents plus LPVr
or SQV/r with super
boosted dosing of RTV
 (LPV/r 400 mg/400 mg
twice daily, OR
 LPV/r 800 mg/200 mg
twice daily, OR
 SQV/r 400 mg/400 mg
twice daily)
 Rifampicin significantly
reduces the levels of bPIs,
limiting the effective options.
Use of extra doses of ritonavir
with selected bPIs (LPV and
SQV) can overcome this
effect but with increased rates
of toxicity
 In case of ART failure, TDF +
Hepatitis B co infection
 AZT + TDF + 3TC or FTC
+ ATV/r or LPVr
3TC or FTC should be
maintained for anti-HBV
activity and the second-line
regimen should include other
drugs with anti-HIV activity
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
98
Table 26: ART switching criteria
Failure
Definition
 New or recurrent WHO
Clinical failure
stage 4 condition
Comments
 Condition must be differentiated from
immune reconstitution inflammatory
syndrome (IRIS)
 Certain WHO clinical stage 3 conditions
(e.g. pulmonary TB, severe bacterial
infections), may be an indication of
treatment failure
 Fall of CD4 count to
baseline (or below) OR
 50% fall from on-
Immunological
failure
treatment peak value OR
 Persistent CD4 levels
below 100 cells/mm3
 Repeated Plasma viral
Virological failure
load above 5000
copies/ml
 Without concomitant infection to cause
transient CD4 cell decrease
 The optimal viral load threshold for
defining virological failure has not been
determined. Values of >5 000 copies/ml
are associated with clinical progression
and a decline in the CD4 cell count
Adapted from: WHO Antiretroviral therapy for HIV infection in adults and adolescents: recommendations
for a public health approach 2010 revision.
Table 27: Monitoring ART in those at higher risk of adverse events
ARV drug
Major toxicity
d4T
 Lipodystrophy
 Neuropathy
 Lactic acidosis
AZT
 Anemia
 Neutropaenia
TDF
 Renal
dysfunction
EFV
 Teratogenicity
 Psychiatric
NVP
illness
 Hepatotoxicity
High-risk situations















Age >40 years
CD4 count of <200 cells/mm3
BMI >25 (or body weight >75kg)
Concomitant use with INH or ddI
CD4 count of <200 cells/mm3
BMI <18.5 (or body weight <50 kg)
Anemia at baseline
Underlying renal disease
Age >40 years
BMI <18.5 (or body weight <50 kg)
Diabetes mellitus
Hypertension
Concomitant use of a PI or nephrotoxic drugs
First trimester of pregnancy (do not use EFV)
Depression or psychiatric disease (previous or at
baseline)
 HCV and HBV co infection
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
99
Figure 6: d4T toxicity assessment
Does pt have cough, abdominal pain, and erythematous serpiginous lesions? Assess all patients on d4T
first line regiment at their next clinic visit using algorithm below
*Assess for possible 1st line ART failure
Failure to 1st line ART not confirmed
Failure to 1st line ART confirmed
**Assess for d4T toxicity
No suspected
toxicity
Suspected
toxicity
Continue with d4T
first line regimen and
monitor patient for
treatment failure and
d4T toxicity
Substitute/change
from d4T to TDF or
AZT based first line
regimen.
Prepare the patient and switch to 2nd line ART
as per national ART
*Suspect failure if patient has or recently had any one of following:
 New or recurrent WHO stage 3 or 4 condition
 Last routine CD4 count show a 50% fall from on-treatment peak value OR is persistently <100
cells/mm3
 Plasma viral load of above 5000 copies/ml (For clients with suspected failure, diagnose failure
using viral load test as below (see information on availability of viral load test)
**Suspect d4T toxicity if any of the following is present:
 Neuropathy: Recent or current symptoms of burning/tingling, numbness, weakness, unable to
walk, sensory loss in limbs.
 Lipodystrophy: Any noticed changes to body shape or dimpling of the skin by the patient or
clinician
 Lactic acidosis: Recent or current symptoms of weight loss, fatigue, muscle pain, abdominal
pain and
From: Republic of Kenya, Ministry of Health, NASCOP.
100
SOP 15: Switching to third-line ART regimens
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide timely and appropriate changes in ART when second-line treatment
failure is diagnosed in adults with HIV, as part of pharmacologic vigilance in an
integrated HIV service package.
Introduction
Third-line regimens should include new drugs such as second-generation NNRTIs
(etravirine) and PIs (darunavir), and new classes of drugs such as integrase inhibitors
(raltegravir) when feasible. Third line regimen decision-making and implementation
should be made in consultation with an HIV specialist whenever possible.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment
 Pharmacist
 HIV Specialist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (treatment failure register, ART complications
register, d4T register, HIV client register, follow-up/default register, etc) as per
national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
4. Second and third line ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
101
Procedure
15.1 Recognize need to switch from second-line to third-line ART regimen and
implement switch in a timely manner and within available resources, according to
national protocol
 Review patient records to confirm accurate diagnosis of second-line regimen failure
and rule out poor adherence as contributing factor:
 Conduct or update directed medical history and directed physical exam to confirm
symptoms, signs and timing of second-line regimen treatment failure
 Review CD4, viral load and other lab results that led to diagnosis of second-line
regimen treatment failure, and conduct or order priority additional laboratory tests
(CD4, viral load) if required to confirm diagnosis
 Possible adverse drug reactions
 Rule out all possible non-resistance causes of treatment failure
15.2 When second-line regimen failure from drug is confirmed, select appropriate
third-line regimen:
 Consider the following principles when switching from second-line to third-line
regimens in resource-limited settings:
 Third-line regimen should include at least two new ARVs to which patient is likely
susceptible
 Patients on failing second-line regimens with no new ARV options readily
available should be maintained on a tolerated regimen if possible
 If patient develops WHO Stage 4 AIDS-defining illness while on second-line
therapy, consult with HIV Specialist to consider stopping ART and institution of
palliative care
 If third-line ARVs and genotype resistance testing are readily available:
 Order or refer for genotype resistance testing while patient is still on failing
second-line regimen, or no more than 4 weeks after discontinuing failing regimen
if possible
 Do not wait longer than 4 weeks for return of genotype resistance test results
before consulting HIV specialist to change to an empiric third-line regimen
 Modify third-line regimen if indicated by resistance test results when they become
available
 Discuss in depth with patient and partner/family possible non-adherence or
discontinuation as potential contributing factor to treatment failure
 Provide option for intensive adherence counseling and active re-involvement of
adherence partner to reduce adherence barriers
102
 Schedule more frequent clinic visits (every 2 weeks if feasible) until efficacy of new
regimen and adherence reestablished:
 Advise sooner return to clinic if signs and symptoms do not resolve or reoccur
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete ART enrollment form, ART treatment failure forms
 Complete paperwork for laboratory tests or other referrals, if applicable
103
Table 28: Toxicities of third-line ARVs
ARV
Toxicities
 Skin rash (10%) — DRV has a sulfonamide moiety; StevensJohnson syndrome and erythrema multiforme have been reported
 Hepatotoxicity
 Diarrhea, nausea
 Headache
Darunavir (DRV)
 Hyperlipidaemia
 Transaminase elevation
 Hyperglycaemia
 Fat maldistribution
 Possible increased bleeding episodes in patients with hemophilia
 GI intolerance, nausea, vomiting, diarrhea
 Paresthesias — circumoral and extremities
 Hyperlipidaemia (especially hypertriglyceridaemia
Ritonavir (RTV)
 Hepatitis
(as
 Asthenia
pharmacokinetic
 Taste perversion
booster)
 Hyperglycaemia
 Fat maldistribution
 Possible increased bleeding episodes in patients with hemophilia
 Nausea
 Headache
Raltegravir
 Diarrhea
(RAL)
 Pyrexia
 CPK elevation
 Rash (2 % discontinuation because of rash during clinical trials)
 Hypersensitivity reactions have been reported, characterized by
Etravirine (ETV)
rash, constitutional findings, and sometimes organ dysfunction,
including hepatic failure
 Nausea
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
104
Integrated Sexual and Reproductive
Health
Background
Although women and men with HIV and their partners need the same routine SRH care
as those who do not have HIV, there are special SRH considerations that should be
addressed as part of comprehensive HIV care. Regardless of HIV status, men and
women of reproductive age need access to family planning services. Family planning
allows individuals and couples to anticipate and attain their desired number of children
and the spacing and timing of their births. It is achieved primarily through use of
contraceptive methods. SOP 16 provides guidance on contraceptive services to men
and women with HIV.
STIs are a common and serious problem worldwide. Many STIs are curable with
effective treatment, but they continue to be a major public health concern in both
industrialized and developing countries. WHO estimates that, globally, more than 340
million new cases of syphilis, gonorrhea, chlamydia and trichomoniasis occur every year
in men and women aged between15–49 years. Not only does the presence of STIs
increase the likelihood of both transmitting and acquiring HIV, but many STIs are more
difficult to treat in people who are immunosuppressed (e.g., chancroid and syphilis) —
emphasizing the importance of STI prevention, early diagnosis and treatment,
particularly in those living with HIV (see SOP 17).
In women with HIV infection where routine pap smears are conducted, 30–60% of Pap
smears exhibit cytological abnormalities and 15–40% have evidence of dysplasia. More
than 40% of HIV positive women have low grade squamous intraepithelial lesion (LSIL).
These rates are more than ten times higher than those observed among HIV-negative
women. Progression of cervical disease is faster in HIV positive women as well, and
invasive cervical cancer included in the list of AIDS-defining illnesses. All HIV positive
women should have access to gynaecological services. HIV providers should be
trained to conduct routine screenings and sources for referrals should be identified. In
areas with high volume of HIV positive women, it is recommended that a gynecologist
provide these much needed services. In many settings yearly Pap smear is not yet
achievable and annual routine visual inspection is the current clinical norm. SOP 18 is
included for use in settings where pap smears are available, with hope that the test will
become more widely available in the near future. SOP 19 provides an overview of the
HIV-related treatment for women of reproductive age.
Women with HIV often face disproportionate responsibility for HIV and STI infection
within their primary partnership/relationship, for prevention of transmission and
reinfection, and for care of children and family regardless of their own health status.
Men also need support to deal with the burdens resulting from HIV and fulfilling their
responsibility of ensuring HIV is not further transmitted. As living with HIV can bring
105
with it a number of emotional, social and physician challenges, all men and women with
HIV need access to counseling and support (SOP 20). They also need support and
advice on how to prevent transmitting HIV to others (SOP 21).
SOPs 16, 17, 18, 19, 20 and 21, although presented as separate SOPs for simplicity
are all sexual and reproductive health services that need to be integrated into HIVrelated care and treatment services. They are unlikely to be offered as distinct separate
services, as presented here, but rather as part of a continuum of care for the PLHIV.
Definitions
 Unsafe sex
 HIV is mainly spread through unsafe sex. Unsafe sex is any kind of sex that puts
a person, or his or her sexual partners, at risk of getting a sexually transmitted
infection, including HIV, or unwanted pregnancy.
 It is very important for health workers to be comfortable talking about sex and
reproduction with their clients. Frank, factual discussions about sex and sexuality
can provide clients with the information they need to protect themselves and their
partners from sexually transmitted infection and unplanned pregnancy.
 Sex (as a noun): Refers to the physiological attributes that identify a person as male
or female (genital organs, predominant hormones, ability to produce sperm or ova,
ability to give birth, etc.).
 Safer sex sexual activity with the use of measures (such as latex condoms) to avoid
the transmission of HIV, other STIs and unintended pregnancy. Safer sex includes
partner reduction, mutual monogamy, use of condoms, avoidance of sexual activity
that involves exchange of body fluids (such as kissing, hugging, or mutual
masturbation rather than intercourse), and abstinence (see also “dual protection”
below).
 Dual protection: preventing STIs, HIV, and unwanted pregnancy at the same time.
Various strategies include:
 Being abstinent or engaging in sexual behaviors that do not involve exchange of
sexual fluids (hugging, kissing, holding hands, massaging, bathing or showering
together, body rubbing (with clothes on), sharing fantasies, masturbation)
 Being in a monogamous relationship in which both partners are free of STIs and at
least one partner is using effective contraception
 Using male or female condoms
 Using male or female condoms to protect against STIs and a second method to
protect against unplanned pregnancy (often a hormonal method)
 Positive prevention: supporting clients to understand the transmission risk of certain
activities and provide guidance to help them reduce risky behavior, have good sexual
and reproductive health, and prevent new HIV infections. Positive living also
includes:
106
 Keeping the mind healthy (having a positive outlook toward living and life),
 Keeping the body healthy,
 Keeping the soul and spirit healthy (for example, the things we do to feel good on
the “inside” and feel a sense of peace and contentment), and
 Living responsibly with HIV and preventing new HIV infections.
 Contraception: the intentional prevention of conception through the use of various
devices, sexual practices, chemicals, drugs, or surgical procedures. This means that
something (or some behavior) becomes a contraceptive if its purpose is to prevent a
woman from becoming pregnant. Birth control techniques and methods include
contraception (the prevention of fertilization), contragestion (preventing the
implantation of the embryo) and abortion (the removal or expulsion of a fetus or
embryo from the uterus).
 Family planning is the planning of when to have children, and the use of birth
control and other techniques to implement such plans. Family planning encompasses
birth control, as well as prevention and management of sexually transmitted
infections, pre-conception counseling and management, and infertility management.
Family planning is usually applied to a female-male couple who wish to control the
number and spacing of pregnancies.
 Family planning services are the educational, comprehensive medical or social
activities that enable individuals, including minors, to determine freely the number
and spacing of their children and to select the means by which this may be achieved.
Policy
1. Family planning and positive prevention services are most effective if presented to
the client with HIV and his or her partner.
2. Clients with HIV may need to be referred to other health services or community
services to ensure all sexual and reproductive health service needs are met. Care
should be coordinated as much as possible to reduce the burden of visits.
Responsibility at health facility
 A single individual should be assigned at each health facility to establish standards
according to national guidelines and supervise not only the integration of sexual and
reproductive health services into HIV treatment and care, but also the actual
services, once established.
 Sexual and reproductive health services are provided by all health workers. In clinics
with multidisciplinary teams, clinical staff provide contraceptive services and
counseling while non-clinical staff — including peer educators — can provide clients
with support on negotiating safer sex.
107
SOP 16: Contraception
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide safe and effective contraception for HIV positive women who wish to
postpone pregnancy as part of an integrated HIV service package.
Introduction
 Pre-conception counseling and pregnancy planning are important components of HIV
care and treatment services for women of childbearing age and their partners.
Contraceptive services can be provided as part of integrated maternal child health
services, and incorporated into HIV care and treatment for men and women living
with HIV attending CTCs.
 HIV positive women/couples can use most family planning (FP) methods.
 WHO has developed a Medical Eligibility Criteria for contraceptives (2004).
 There is emerging data on the use of hormonal contraception and increased risk of
HIV acquisition. Currently there is no change in the guidance - women living with HIV
can continue hormonal contraceptive use – but the WHO will review these guidelines
in February 2012.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment and SRH
 Pharmacist
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, contraception/family
planning register, follow-up/default register, etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
108
f.
Disposable exam gloves
4. Contraceptive supplies, antibiotics for STI treatment
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
Provide contraceptive advice and services to all women and men living with HIV
who wish to prevent or postpone pregnancy, according to national guidelines
 At initial visit:
 Review and update patient record, medical history and past clinical and laboratory
findings to assess current HIV status, treatment status and history of
contraindications to any family planning methods
 Discuss particular importance of contraception for HIV infected women: to
promote healthy timing and spacing of pregnancies
 Explain that for ART-eligible HIV positive women, pregnancy is best deferred until
effective ART regimen has improved clinical and laboratory parameters
(significant CD4 increase, viral load decrease to undetectable if possible) to
increase viability of pregnancy, assure the mother’s health, and decrease risk of
HIV transmission to the infant
 Discuss reproductive intentions of woman/partner and expectations of
partner/family that might influence contraceptive use
 Provide counseling on FP methods, and assist in selection of medically and
culturally appropriate method
 Explain potential side effects of individual FP methods as appropriate
 Define and explain dual protection and encourage regular and reliable condom
use to prevent HIV transmission, even if using another FP method as primary
means of preventing/postponing pregnancy
 Encourage use of female condoms and distribute if available. Encourage trial use
in women who appear skeptical
 Dispense and encourage use of male condoms for FP or dual protection and offer
assistance in condom negotiation skills
 Discuss possible interaction between certain ARVs and other HIV and non-HIV
medications. For HIV positive women on ART, some drugs — including ARVs — can
interact with hormonal contraceptives:
 Protease inhibitors (PIs):
 ritonavir, lopinavir/ritonavir and darunavir — decrease estrogen levels in
combined oral contraceptive users
109
 atazanivir — increases estrogen levels
 NNRTIs:
 nevirapine (NVP) — decreases estrogen levels
 efavirenz (EFV) — increases estrogen levels
 Rifampicin and certain antibiotics may reduce the effectiveness of hormonal
contraceptive methods (among all women, not just HIV positive women)
 In the above cases, change contraceptive method or add a second method to current
contraceptive choice and always recommend condoms for dual protection.
 Avoid use of EFV in first trimester of pregnancy or in HIV positive women unless
assured of effective contraception as EFV can cause neural tube defects in first
trimester.
 Conduct directed medical history and physical examination to rule out absolute
contraindications to use of hormonal or intrauterine contraception.
 Conduct Hgb, STI screen and other laboratory tests as indicated to detect anemia or
other conditions that could contraindicate use of hormonal or intrauterine
contraception.
 Initiate family planning, using the method of client’s choice from among all methods
appropriate for HIV positive women, including:
 Progesterone-only injectable methods (Depo-Provera): Advise HIV positive
women to receive re-injection two weeks earlier than the scheduled three-monthly
revisit
 Progestin-only contraceptive pills (minipills) can safely be used by HIV positive
women; even those who are breastfeeding because they do not contain estrogen
thus do not reduce breast milk production
 Combined oral contraceptives (birth control pills): Certain ARVs can influence
estrogen levels and therefore reduce effectiveness of combined oral
contraceptives (see above). Combined oral contraceptives should not be used by
HIV positive breastfeeding women, as estrogen reduces breast milk production
 Intrauterine devices (IUD) can be used by HIV-positive women except in women
with advanced HIV disease who are not on ART. Women who have a current STI
or history of recurrent STIs should not use IUDs. Higher rates of pelvic
inflammatory disease occur in the presence of some STIs. Condom use should be
encouraged in women who select IUDs as their contraceptive method. IUDs
insertion may be safest if delayed a month or more after delivery
 Voluntary sterilization (tubal ligation or male vasectomy) is an option to
permanently prevent pregnancy. Women/partners should be thoroughly
counseled and their absolute intention to permanently end fertility should be
assessed and documented prior to performing sterilization
 Provide or refer for additional counseling HIV positive women/couples who desire a
110
pregnancy:
 Explain risks of unprotected intercourse in presence of HIV disease
 Explain that HIV positive couples and discordant couples who desire children
should confine unprotected intercourse to fertile period
 Explain that adherence to ART and undetectable viral load may allow conception
without transmission of HIV to partner Explain that genital ulcerative disease
(GUD) if present during intercourse, can increase chance of viral transmission
 At follow-up visits:
 Review and update patient record
 Ask patient about changes in reproductive health status (new pregnancy, desire
to become pregnant in near future, any gynecologic or STI diagnoses received
since last visit)
 Review current use of and satisfaction with FP and offer to change method if
appropriate
 Review rationale for FP, provide counseling on appropriate methods for people
living with HIV and offer to initiate or resupply choice of method if appropriate
At all visits:
Emphasize dual protection: the use of a routine FP method as well as male or female
condoms.
 For all visits, schedule next appointment:
 Advise patient to return sooner return if there are problems
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
111
SOP 17: STI screening for adults and adolescents
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide HIV positive clients screening for sexually transmitted infections (STI),
according to national guidelines and STI protocols and as part of an integrated HIV
service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment and SRH
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, STI register, followup/default register, etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
g. Speculums for internal vaginal examination, bright light source for cervical
examination speculum
h. Examination table and clean paper or cloth covering
4. Contraceptive supplies, antibiotics for STI treatment
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
 Review and update patient record, medical history and past clinical and laboratory
findings to assess current HIV status, treatment status and history of STIs or related
gynecologic conditions.
112
 Women: Conduct pelvic, genital, rectum and oropharynx examination, as directed by
sexual history:
 Gently palpate the abdomen for pelvic masses and tenderness
 Palpate the inguinal region to detect the presence or absence of enlarged lymph
nodes and buboes
 Examine the vulva, anus and perineum
 The physical examination may include, where possible, an internal pelvic
examination involving (a) bimanual examination to check for active pelvic
inflammatory disease; shape, size and position of uterus for uterine masses, for
example, pregnancy and (b) speculum examination to check for the nature of the
vaginal discharge, purulent cervicitis and/or erosions
 Record the presence or absence of buboes, ulcers, and vaginal discharge, noting
the type, color and amount
 Men: Conduct genitalia/urethra, rectum and oropharynx examination, as directed by
sexual history:
 Palpate the inguinal region for enlarged lymph nodes and buboes
 Palpate the scrotum, feeling for individual parts of the anatomy: testes, spermatic
cord, and epididymis
 Examine the penis, noting any rashes or sores. Retract the foreskin if present, and
look at the glans penis and urethral meatus
 If there is no obvious urethral discharge, milk the urethra or ask the patient to milk
the urethra gently to express any discharge. If a discharge is present, wipe it with
a swab and dispose
 Record the presence or absence of buboes, ulcers, and urethral discharge, noting
the color and amount
 Collect samples of cervical and vaginal secretions, vaginal/penile discharge,
exudates or scrape of abnormal tissue or lesions for laboratory evaluation if
indicated.
 Conduct or refer for rapid syphilis test, wet mount and gram stain of vaginal/penile
discharge, culture for gonorrhea, Chlamydia, viral culture for HPV if indicated.
 Conduct RPR at baseline visit.
 If laboratory testing not available or national guidelines recommend, use syndromic
STI treatment algorithms.
 Treat according to WHO syndromic algorithms or test results, adhering to national
STI and HIV guidelines (see Table 29, below).
 Refer for other gynecologic/genital evaluation and treatment, if required.
 Explain findings and referral or next steps to patient.
113
 Discuss prevention of STIs:
 Initiate contact tracing, examination and treatment if required
 Define and explain dual protection and encourage regular and reliable condom
use, even if using another FP method
 Encourage use of female condoms and distribute if available. Encourage trial use
in women who appear skeptical
 Dispense condoms for FP or dual protection and offer assistance in condom
negotiation skills
 Schedule next appointment:
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
Table 29: STD treatment guidelines table for adults and adolescents
Disease
Recommended Regimens
CHLAMYDIA
Uncomplicated  Azithromycin OR
Genital/Rectal/P  Doxycycllna
haryngeal
Infections
Pregnant
Women
Gonorrhea
Uncomplicated
Genital/Rectal
Infections
Pharyngeal
Infections
Pregnant
Women
 Azithromycin OR
 Amoxicillin
Dual therapy with
 Ceftriaxone OR, if not an
option
 Cefixime
PLUS
 Azithromycin OR
 Doxycycline
Dual therapy with
 Ceftriaxone
PLUS
 Azithromycin OR
 Doxycycline
Dual therapy with
 Ceftriaxone or, if not an
Dose / Route
1 g po
100 mg po bid x 7 d
1 g po
500 mg po bid x 7 d
250 mg IM
Alternative Regimens: To be used if medical
contraindication to recommended regimen.
 Erythromycin base 500 mg po qid x Id OR
 Erythromycin ethylsuccinate 800 mg po qid x 7
OR
 Levofloxacin 600 mg po qd x 7 d OR
 Ofloxacin 300 mg po bid x 7 d
 Erythromycin base 500 mg po qld x 7 d OR
 Erythromycin base 250 mg po qid x 14 d OR
 Erythromycin ethyl succinate 800 mg po qid x 7 d
OR
 Erythromycin ethyl succinate 400 mg po qid x 14 d
 Cefpodoxane 400 mg po OR
 Cefuroxime axetil 1 g po OR
 Azithromycin 2 g po in a single dose
400 mg po
1 g po
100 mg po bid x 7 d
 Azithromycin 2 g po in a single dose
250 mg IM
1 g po
100 mg po bid x 7 d
250 mg IM
 Cefpodoxane 400 mg po OR
 Cefuroxime axetil 1 g po OR
114
Disease
Pelvic
Inflammatory
Disease
Recommended Regimens
option
 Cefixime
PLUS
 Azithromycin
Parenteral
 Either Cefotelan OR
 Cefoxilin
PLUS
 Doxycycline OR
 Clindamycin
PLUS
 Gentamicin
IM/Oral
 Either Ceftriaxone OR
 Cefoxitin with Probenecid
PLUS
 Doxycycline
PLUS
 Metronidazole if BV is
present OR cannot be ruled
out
 Azithromycin OR
Cervicitis
 Doxycycline
PLUS
 Metronidazole if BV OR
trichomoniasis is present
Nongonococcal  Azithromycin OR
Urethritis
 Doxycycline
Epididymitis
Chancroid
Likely due to Gonorrhea OR
Chlamydia
 Ceftriaxone
PLUS
 Doxycycline
Likely due to enteric
organisms
 Levofloxacin OR
 Ofloxacin
 Azithromycin OR
 Ceftriaxone OR
 Ciprofloxacin OR
 Erythromycin base
 Doxycycline
Lymphogranuloma
Venereum
TRICHOMONIASIS
Non-Pregnant
 Metronidazole OR
Women
 Tinidazole
Pregnant
 Metronidazole
Women
BACTERIAL VAGINOSIS
Adults/
 Metronidazole OR
Adolescents
 Metronidazole gel OR
 Clindamycin cream
Dose / Route
Alternative Regimens: To be used if medical
contraindication to recommended regimen.
 Azithromycin 2 g po in a single dose
400 mg po
1 g po
2 g IV q 12 hours
2 g IV q 6 hours
100 mg po OR IV q 12
hours
Parenteral
 Ampicillin/Sulbactam 3 g IV q 6 hours
PLUS
 Doxycycline 100 mg po OR IV q 12 hours
900 mg IV q 8 hours
2 mg/kg IV OR IM
followed by 1.5 mg/kg
IV OR IM q 8 hours
Oral
 Levofloxacin 500 mg po qd x 14 d OR
 Ofloxacin 400 mg po bid x 14 d OR
 Ceftriaxone 250 mg IM in a single dose AND
Azithromycin 1 g po once a week for 2 weeks
PLUS
 Metronidazole 500 mg po bid x 14 d if BV is present
or cannot be ruled out
250 mg IM
2 g IM,1 g po
100 mg po bid x 14 d
500 mg po bid x 14 d
1 g po
100 mg po bid x 7 d
500 mg po bid x 7 d
1 g po
100 mg po bid x 7 d




Erythromycin base 500 mg po qid x 7 d OR
Erythromycin ethyl succinate 800 mg po qid x 7 d OR
Levofloxacin 500mg po qd x 7 days OR
Ofloxacin 300 mg po bid x 7 d
250 mg IM
100 mg po bid x l0 d
500 mg po qd x 10 d
300 mg po bid x 10 d
1 g po
250 mg IM
500 mg po bid x 3 d
500 mg po tid x 7 d
100 mg po bid x 21 d
 Erythromycin base 500 mg po qid x 21 d or
 Azithromycin 1 g po q week x 3 weeks
2 g po
2 g po
2 g po
 Metronidazole 500 mg po bid x 7 d
500 mg po bid x 7 d
0.75%, one full
applicator (5g)
Intravaginally qd x 5 d
 Tinidazole 2 g po qd x 2 d OR
 Tinidazole 1 g po qd x 5 d OR
 Clindamycin 300 mg pa hid x 7 d OR
 Metronidazole 500 mg po bid x 7 d
115
Disease
Recommended Regimens
 Metronidazole OR
 Metronidazole OR
 Clindamycin
ANOGENITAL WARTS
External
Patient-Applied
Genital/
 Imiquimod 5% cream OR
Perianal Warts
 Podofilox 0.5% solution
gel OR
Pregnant
Women
 Sinecatechins 15%ointment
Provider-Administered
 Cryotherapy OR
 Podophyllin resin 10%-25%
in tincture of benzoin OR
 Trichloroacetic acid (TCA)
80%-90% OR
 Bichloroacetic acid 80%-90%
OR
 Surgical removal
Mucosal Genital  Cryotherapy OR
Warts
 TCA OR SCA 80%-90% OR
 Podophyllin resin 10%-25%
in tincture of benzoin OR
 Surgical removal
ANOGENITAL HERPES SIMPLEX VIRUS (HSV)
First Clinical
 Acyclovir OR
Episode of
 Acyclovir
Anogenital
OR
Herpes
 Famcidovir OR
 Valacydovir
Established
Infection
 Acyclovir OR
Suppressive
Therapy
 Famcidovir OR
 Valacyclovir OR
 Valacyclovir
Episodic
Therapy for
Recurrent
Episodes
HSV/HIV coinfected:
Suppressive
Therapy
HSV/HIV coinfected:
Episodic
Therapy for
Recurrent
Episodes






Acyclovir OR
Acyclovir OR
Acyclovir OR
Famcidovir OR
Famcidovir OR
Famcidovir OR
 Valacyclovir OR
 Valacyclovir
 Acyclovir OR




Famcidovir OR
Valacyclovir
Acyclovir OR
Famcidovir OR
Dose / Route
2%, one full applicator
(5g) intravaginally qhs
x7d
500 mg po bid x 7 d
250 mg po tid x 7 d
300 mg po bid x 7 d
Topically qhs 3 x wk up
to 16 wks
Topically bid x 3 d
followed by 4 d no tx
for up to 4 cycles
Topically lid, for up to
16 wks
Alternative Regimens: To be used if medical
contraindication to recommended regimen.
 Clindamycin ovules 100 mg intravaginally qhs x 3 d
Alterative Regimen
 Intralesional interferon OR
 Laser surgery OR
 Photodynamic therapy OR
 Topical cidofovir
Apply once q 1–2 wks
Apply once q 1–2 wks
Apply once q 1–2 wks
Apply once q 1–2 wks
Vaginal, urethral
meatus, and anal
Vaginal and anal
Urethral meatus only
Anal warts only
400 mg po tid x 7–10 d
200 mg po 5 x/day x 7–
10 d
250 mg po tid x 7–10 d
1 g po bid x 7–10 d
400 mg po bid
250 mg po bid
500 mg po qd
1 g po qd
400 mg po tid x 5 d
800 mg po bid x 5 d
800 mg po tid x 2 d
125 mg po bid x 5 d
1000 mg po bid x 1 d
500 mg once then 250
mg bid x 2 d
500 mg po bid x 3 d
1 g po qd x 5 d
400–800 mg po bid OR
tid
500 mg po bid
500 mg po bid
400 mg po tid x 5–10 d
500 mg po bid x 5–10 d
1 g po bid x 5.10 d
 Valacyclovir
116
Disease
Recommended Regimens
SYPHILIS
Primary,
 Benzathine penicillin G
Secondary, and
Early Latent
2.4 million units IM
Late Latent and  Benzathine penicillin G
Latent of
Unknown
Duration
Neurosyphilis
7.2 million units,
administered as 3
doses of 2.4 million
units IM each, at 1–wk
intervals
 Aqueous crystalline penicillin 18–24 million units
G
daily, administered as
3–4 million units IV q 4
hours x 10–14 d
Pregnant
 Benzathine penicillin G
women:
Primary,
Secondary, and
Early Latent
Pregnant
 Benzathine penicillin G
women: Late
Latent and
Latent of
Unknown
Duration
Pregnant
 Aqueous crystalline penicillin
women:
G
Neurosyphilis
Alternative Regimens: To be used if medical
contraindication to recommended regimen.
Dose / Route
2.4 million units IM





Doxycycline 100 mg po bid x 14 d OR
Tetracycline 500 mg po qid x 14 d OR
Ceftriaxone 1 g IM or IV qd x 10–14 d
Doxycycline 100 mg po bid x 28 d OR
Tetracycline 500 mg po qid x 28 d
 Procaine penicillin G, 2.4 million units IM qd x 10–14
d
PLUS
 Probenecid 500 mg po qid x 10–14 d OR
 Ceftriaxone 2 g IM or IV qd x 10–14 d
 None
7.2 million units,
administered as 3
doses of 2.4 million
units IM each, at 1–wk
intervals
 None
18–24 million units
daily, administered as
3–4 million units IV q 4
hours x 10–14 d
 Procaine penicillin G, 2.4 million units IM qd x 10–14
d
PLUS
 Probenecid 500 mg po qid x 10–14 d
From: California STD/HIV Prevention Training Center California Department of Public Health STD Control
Branch updated January 2011.
117
SOP 18: Cervical screening
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide cervical screening by visual inspection or Pap smear to all HIV positive
women according to national guidelines and as part of an integrated HIV service
package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment and SRH
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, cervical screening, followup/default register, etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c.
Thermometer
d. Weighing scale
e. Paper examination drapes
f.
Disposable exam gloves
g. Speculums for internal vaginal examination, bright light source for cervical
examination speculum
h. Culture materials
i.
High-level disinfectant
j.
Disposable examination gloves
k.
Examination table and clean paper or cloth covering
l.
Cotton-tipped swabs
m. Dilute acetic acid solution (3–5%) or white vinegar
n. Lugol’s iodine solution
o. 0.5% chlorine solution for decontaminating instruments and gloves if reusable
118
p. Pap slides
q. Spatula
r.
Fixative
4. Contraceptive supplies, antibiotics for STI treatment
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
181 Conduct visual inspection of cervix on all HIV positive women if available and
according to national guidelines
 Conduct screening for cervical cancer on all HIV positive women (regardless of
whether she is on ART or not):
 As soon as possible after HIV diagnosis confirmed
 Every 12 months thereafter; if cervical changes have been noted, repeat
screening 6 monthly
 Review and update patient record, medical history and past clinical and laboratory
findings to assess current HIV status, treatment status and history of STIs or
gynecologic conditions including previous abnormal visual inspection/pap smear.
 Conduct pelvic examination with special attention to detection of genital lesions or
abnormalities.
 Collect samples of discharge, exudates or scrape of lesions for laboratory evaluation
if indicated.
 Conduct visual inspection in all HIV-infected women who are not yet
postmenopausal.
 Explain procedure to patient
 Insert speculum and adjust light source for optimum view of cervix
 Remove any discharge, blood or mucus from cervical os with cotton swab
 Identify squamocolumnar junction (or transformation zone) and surrounding area
 Apply acetic acid or Lugol’s iodine to cervix wait 1–2 minutes for color changes to
take place, observe changes with special attention to transformation zone
 Note findings on patient record and draw image in patient record of where cervical
changes were noted
 Acetic acid VI is positive if raised, thickened white plaques or acetowhite
epithelium
 Lugol’s iodine VI is positive if mustard or saffron-yellow colored areas usually
near squamocolumnar junction
119
 Remove any remaining solution from cervix and inform/reassure patient she may
notice some staining from solution the day of/ day after application of solutions
 Remove speculum
 Discuss results with patient. If negative, recommend repeat visual inspection in one
year. If positive, consult with gynecologist if available or refer for further diagnostic
testing/treatment.
 Refer for screening if not available at site, or for other gynecologic evaluation
(colposcopy, biopsy) if required.
18.2 Conduct Pap smear on all HIV positive women, if available, and according to
national guidelines
 Conduct cervical cancer screening on all HIV positive women (regardless of whether
she is on ART or not):
 As soon as possible after HIV diagnosis confirmed
 Every 12 months thereafter
 Review and update patient record, medical history and past clinical and laboratory
findings to assess current HIV status, treatment status and history of STIs or
gynecologic conditions including previous abnormal pap smear.
 Conduct pelvic examination with special attention to detection of genital lesions or
abnormalities.
 Collect samples of discharge, exudates or scrape of lesions for laboratory evaluation
if indicated.
 Conduct pap smear.
 Refer for screening if not available at site, or for other gynecologic evaluation
(colposcopy, biopsy) if required.
 Repeat abnormal screening examinations according to the result and adhering to
national guidelines:
 Atypical cells of undetermined significance (ASCUS) repeat in one year and if still
ASCUS, refer for baseline colposcopy
 LSIL, repeat in one year and if still LSIL, refer for baseline colposcopy (more than
40% of HIV positive women have LSIL)
 HSIL, refer for colposcopy if available
 Carcinoma in situ: refer immediately to gynecologist if available
 Explain findings and referral or next steps to patient if required.
18.3 Upon completion of all patient visits
120
 Schedule next appointment:
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
121
SOP 19: ART and HIV-related treatment for WRA
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide appropriate ART and HIV-related treatment to all HIV positive women of
reproductive age (WRA) as part of an integrated HIV service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment and SRH
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, follow-up/default register,
etc) as per national guidelines
3. Equipment/supplies:
a. Stethoscope
b. BP monitoring equipment
c. Thermometer
d. Weighing scale
e. Paper examination drapes
f. Disposable exam gloves
4. CTX, ARV medications, multivitamins
5. Counseling materials as teaching aids and for distribution to patients
6. Laboratory test referral request form if required
Procedure
Provide appropriate ART and HIV-related treatment to all HIV positive WRA
 A guiding principle for ART in HIV positive WRA or pregnant women is that
therapeutic decisions should be based solely on their need and eligibility for ART.
 Special circumstances that should be considered when initiating or evaluating ART in
WRA include the following.
122
Prior to initiating ART in all WRA
 Evaluate women for any past history of sd-NVP and AZT/3TC tail for PMTCT within
the previous 12 months.
 Assess reproductive potential and reproductive intentions.
 Determine baseline CD4 cell count regarding risk for NVP hepatotoxicity with high
baseline values. Avoid NVP if baseline CD4 cell count > 250 (women) or > 400 (men)
cells/L.
 Use AZT-containing ART for eligible pregnant women, if possible.
Non-pregnant HIV-positive women
 Remind at every visit about the teratogenic effects of EFV during first trimester of
pregnancy; need to use reliable contraception while on EFV; importance of returning
to clinic immediately if pregnancy occurs or if pregnancy desired so EFV can be
discontinued.
 Use LPV/r in women who received sd-NVP within past 6 months to reduce risk of
virologic failure with NNRTI-based ART.
 Advise non-pregnant women on TDF to return to clinic immediately if pregnancy
occurs or if pregnancy desired so switch from TDF to AZT can be considered to
reduce potential risk of fetal bone mineral density changes.
 Lactic acidosis due to NRTIs is more common in women, especially when BMI is
greater than 18.5 kg/m and/or when baseline CD4 count is greater than 250 cells/mL.
Women already on ART who become pregnant:
 Maintain current ART regimen except:
 Switch EFV to NVP during first trimester of pregnancy; consider switch back to
EFV beginning second trimester if indicated
 Switch patients already on TDF who become pregnant to AZT to avoid potential
effects on fetal bone mineral density (as above) and to provide additional PMTCT
effect. After delivery, discuss with patient and either continue AZT or switch back
to TDF
 Pregnant women should discontinue fluconazole as it is teratogenic; if required for
secondary prophylaxis, women who desire pregnancy should reliably delay
pregnancy until fluconazole can be safely discontinued.
Women with prior exposure to ARVs for PMTCT
 Initiate a non-NNRTI-based ART in women who have received single-dose
nevirapine (sdNVP) — alone or in combination with other drugs without an NRTI tail
— within 12 months of initiating ART. If an NNRTI-based regimen is started, conduct
123
viral load testing at 6 months and, if there are >5000 copies/ml, switch to a bPI-based
regimen.
 Initiate a standard NNRTI-based ART regimen in women who have received sdNVP
— alone or in combination with other drugs with an NRTI tail — within 12 months of
initiating ART. Conduct viral load-testing at 6 months. If the viral load is >5000
copies/ml, change to a bPI.
 Initiate a standard NNRTI-based ART regimen in women who have received sdNVP
— alone or in combination with other drugs with or without a NRTI tail — more than
12 months before starting therapy, if possible. The viral load should be evaluated at 6
months and if it is >5000 copies/ml, change bPI-based regimen.
 Initiate a standard NNRTI regimen in women who have received ARV drugs such as
AZT alone — without sdNVP — for PMTCT.
Upon completion of all patient visits
 Schedule next appointment:
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
 Complete paperwork for laboratory tests or other referrals, if applicable
124
Table 30: ART regimens recommended for women with prior exposure to PMTCT
regimen
Previous ARV exposure for PMTCT
Recommendations for initiation of ART when
needed for treatment of HIV for maternal health
sdNVP1 (+/-antepartum AZT) with no
AZT/3TC tail2 in last 12 months
 Initiate a non-NNRTI regimen
 PI preferred over 3 NRTI
sdNVP (+/-antepartum AZT) with an
AZT/3TC tail in last 12 months
 Initiate an NNRTI regimen.
 If possible, check viral load3 at 6 months and if
>5000 copies/ml, switch to second-line ART with
PI
sdNVP (+/-antepartum AZT) with or without
an AZT/3TC tail over 12 months ago
 Initiate an NNRTI regimen
 If possible, check viral load3 at 6 months and if
>5000 copies/ml, switch to second-line ART with
PI
Option A4
Antepartum AZT (from as early as 14
weeks of gestation)
sdNVP at onset of labour*
AZT + 3TC during labour and delivery*
AZT + 3TC tail for 7 days postpartum*
 Initiate an NNRTI regimen
 If possible, check viral load3 at 6 months and if
>5000 copies/ml, switch to second-line ART with
PI
 If no sdNVP was given, start standard NNRTI (viral
load does not need to be checked unless clinically
indicated as no sdNVP received)
* sd-NVP and AZT + 3TC can be omitted if
mother receives >4 weeks of AZT
antepartum
All triple ARV regimens (including Option
B), irrespective of duration of exposure and
time since exposure
Option B4
Triple ARV from 14 weeks gestation until
after all exposure to breast milk has ended
AZT + 3TC + LPV/r
AZT + 3TC + ABC
AZT + 3TC + EFV
TDF + [3TC or FTC] + EFV
1
2
3
4
 Initiate standard NNRTI regimen
 If EFV-based triple ARV was used for prophylaxis
and no tail (AZT + 3TC; or TDF + 3TC; or TDF +
FTC) was given when triple ARV was discontinued
after cessation of breastfeeding (or delivery if
formula feeding), check viral load3 at 6 months and
if >5000 copies/ml, switch to second-line ART with
PI
Single-dose nevirapine (sdNVP) is one 200-mg tablet of NVP.
A tail is the provision of two NRTIs, typically AZT/3TC, for a minimum of 7 days following sdNVP or
the cessation of any NNRTI-based regimen with the objective of minimizing NNRTI resistance.
If viral load is not available, continue NNRTI regimen and monitor clinically (and immunologically if
available).
Options A or B are viewed as equally effective for PMTCT in women who do not require therapy for
their own health and are recommended options in the 2010 update of Use of ARV drugs for treating
pregnant women and preventing HIV infection in infants.
From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision.
125
Table 31: ART options recommended for HIV-infected pregnant women who are
eligible for treatment
Target population
Preferred treatment options
AZT + 3TC + NVP
AZT + 3TC + EFV*
Pregnant women
Comments
Maternal antepartum daily ART,
starting as soon as possible
irrespective of gestational age, and
continued during pregnancy,
delivery and thereafter.
TDF + 3TC (or FTC) + NVP
Daily NVP or twice-daily AZT from
birth until 4 to 6 weeks of age
(irrespective of the mode of infant
feeding).
TDF + 3TC (or FTC) + EFV*
*Avoid use of EFV in the first
trimester and use NVP instead.
From: WHO Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants,
2010 version.
126
SOP 20: Counseling and support for adults and adolescents
living with HIV
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide counseling and support to all HIV positive WRA and their partners, as part
of an integrated HIV service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment and SRH
 Counselors
 Peer counselors, patient advocates, community support workers
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, follow-up/default register,
etc) as per national guidelines
3. Counseling materials as teaching aids and for distribution to patients
Procedure
 As part of every visit, review psychosocial aspects of HIV disease with female clients:
 Adequacy of partner/family support
 Stigma, discrimination
 Family violence
 Additional help required for household duties and child care
 Difficulties adhering to ART regimen or visit schedule
 Discuss realistic solutions and suggest sources of additional support — peer
educator, community home visitor, community-based organizations helping women
and families living with HIV.
 Reinforce clinic staff’s commitment to family-based care and suggest HIV testing for
partner/children/family members.
 Review importance of adherence to clinic visit schedule and referrals and treatment
adherence once ART or preventive treatment (CTX, INH) initiated.
127
 Assess for social issues such as client or family alcohol abuse, psychological or
mental health problems, family violence, joblessness or other issues.
 Discuss sexual and reproductive health (see SOPs 16–19):
 Explain that although ART appears to significantly decrease sexual transmission
of HIV, vigilance still required as unsafe sex while on ART regimen that is not
maximally effective can result in HIV transmission, especially drug resistant HIV.
Strongly recommend safer sex even while on ART to reduce risk of HIV
transmission or reinfection
 Evaluate reproductive intentions and discuss need for contraceptives to avoid
unplanned pregnancy; refer if required: occurrence of unwanted pregnancy while
on ART suggests unsafe sex and associated risks to both HIV-negative sexual
partners and infant
 Demonstrate proper use of male/female condoms and ensure adequate supplies
are available
 Discuss the importance of circumcision for male partners
 Schedule next appointment:
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
128
SOP 21: HIV prevention for people living with HIV
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To provide counseling to PLHIV to support them to reduce the risk of transmitting HIV
to partners — including safer sex and risk reduction counseling — as part of an
integrated HIV service package.
Responsibility
 Physician or clinical officer
 Nurse trained in HIV care and treatment and SRH
 Counselors
 Peer counselors, patient advocates, community support workers
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, follow-up/default register,
etc) as per national guidelines
3. Counseling materials as teaching aids and for distribution to patients
Procedure
 As part of every visit, discuss how to reduce risk of passing or acquiring HIV:
 Reduce the number of sex partners you have
 Use condoms correctly during all sexual encounters
 Practice safer sex — choose sexual activities that do not allow semen, fluid from
the vagina, or blood to enter the mouth, anus or vagina
 Avoid donating blood
 If pregnant, participate in PMTCT interventions — take ARVs during pregnancy,
delivery and breastfeeding; feed your infant safely (breastfeed or formula feed
exclusively for the first 6 months of life) and deliver in a healthcare facility
 Encourage excellent adherence to ART: clients whose HIV infection is well-controlled
with ART have a dramatically reduced risk of passing HIV to sex partners. Stress to
patients that HIV transmission can still occur even if a client is on ART, so he or she
should still use condoms every time.
 Describe symptoms of STIs and stress the importance of prompt treatment if STI is
129
suspected.
 Discuss discordance:
 It is common for partners of PLHIV to still be HIV negative (discordance)
 HIV negative partners in discordant couples are at very high risk of infection
 If discordant couple, explain effective risk reduction options including condoms,
abstinence, separation
 Dispel local myths that may impact on positive prevention, such as cleansing of HIV
infection through sexual intercourse with virgins or minors, belief that condoms
transmit HIV.
 Respond to concerns about sexual function.
 Emphasize that normal sexual activity can continue, with above stated precautions.
 Encourage questions from clients.
 Help patient assess current risk of transmission and make an individual risk reduction
plan.
 Counsel on consistent and correct use of condoms during every sexual encounter:
 Use condoms consistently, even if already infected with HIV or if both partners are
HIV-positive
 Use condoms for vaginal, anal and oral intercourse
 Put on condom before penetrative sex, not just before ejaculation
 Discuss the advantages/disadvantages of both male and female condoms
 Encourage use of water-based lubricants; discourage use of oil-based lubricants
with male condoms
 Demonstrate how to use both male and female condoms using model to
demonstrate correct use
 Request client to demonstrate correct use of condoms
 Discuss potential barriers to consistent and correct use of condoms; discuss
strategies to address these barriers
 Provide techniques/skills for negotiating condom use according to the needs
expressed by clients and role-play condom negotiation with client
 Provide condoms and discuss how client will assure a regular supply of condoms.
 Discuss and recommend disclosure and partner/family testing:
 Explore barriers and explore benefits of disclosure
 Develop individualized strategy for disclosure if client is ready
 Refer to PLHIV support groups or others for additional support, if required.
130
 Schedule next appointment:
 Schedule earlier appointment if required for follow-up of barriers identified
 Record appointment in follow-up register
 Document:
 Record all findings, actions, and discussions in patient record
 Complete all relevant registers as per national guidelines
131
Nutrition
Background
Malnutrition, in every form, presents significant threats to human health. Today the
world faces a double burden of malnutrition that includes both undernutrition and
overweight, especially in developing countries. Routine assessment of nutritional status
is an integral part of comprehensive HIV services.
Hunger and inadequate nutrition contribute to premature illness and early death for
many people with HIV, particularly if not yet on ART. Changes in nutritional status
result from a combination of factors. HIV infection can impair intestinal absorption of
nutrients and nutritional requirements also increase with increased severity of HIV
infection. Changes in appetite and side effects associated with use of ART or other
HIV-related drugs can also contribute to decreased nutritional intake, resulting in
malnutrition. Energy (calorie) requirements increase as HIV progresses from
asymptomatic to symptomatic:
 Asymptomatic clients with HIV require 10–15% more energy than people without HIV,
i.e., they require an extra snack or additional small meal each day just to maintain
their current weight.
 Symptomatic adults with HIV require 20–30% more energy intake — this translates to
another full meal each day or 2–3 additional snacks.
Wasting has been associated with decreased survival, making timely nutritional
assessment and appropriate intervention before substantial deterioration of nutritional
status occurs key.
Definitions
 BMI: stands for body mass index. BMI is an individual's body weight divided by the
square of his or her height or kg/m2. BMI can also be determined using a BMI chart,
which displays BMI as a function of weight (horizontal axis) and height (vertical axis)
using contour lines for different values of BMI or colors for different BMI categories.
Interpretation is as follow:
 BMI less than 16: severely underweight
 16–18.5: underweight
 18.5–25: normal
 25–30: overweight
 BMI of 30 or higher: obese
Policy
1. The HIV epidemic is occurring in populations where malnutrition is already endemic.
132
As an urgent priority, greater political, financial and technical support should be
provided for improving dietary quality and increasing dietary intake to recommended
levels. In addition, focused evidence-based nutrition interventions should be part of
all national AIDS control and treatment programs.
2. Nutrition counseling, care and support interventions for PLHIV will vary according to
nutritional status and the extent of disease progression. Prompt diagnosis and
treatment of HIV-related conditions, including use of ART when indicated, can
contribute to improved nutrition and health.
3. Support should also be given to ensure the preparation of training and educational
materials on nutritional care and support for people living with HIV.
Responsibility at health facility
 A single individual should be assigned at each health facility to ensure staff training
and quality assurance of all nutrition assessment, education, counseling and support.
This individual should also ensure that all services meet or exceed national policies,
practices and guidelines.
 All health workers responsible for providing patient care also need to be trained to
provide education, counseling, and/or support for nutrition assessment, education,
counseling and support.
133
SOP 22: Nutritional assessment
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose

To conduct nutritional assessment according to national guidelines for nutrition and
HIV and as part of an integrated HIV service package.
Responsibility
 Physician, clinical officer, or nurse
 Other health worker
 Nutrition counselor

Peer educators, patient advocates, and community support workers
Supplies
1. Counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, nutrition register, peer
educator register, follow-up/default register, etc) as per national guidelines
3. Equipment/supplies:
a. Adult weighing scale, calculator to determine BMI
4. Nutrition counseling materials as teaching aids and for distribution to patients
5. List of agencies that provide nutrition services by referral
Procedure
 Greet client.
 Review medical records and/or referral forms from other health services for any
previously identified nutritional deficits or nutrition interventions.
 Conduct directed patient history to assess:
 Date(s) of previous nutritional assessments if any
 HIV and non-HIV-related medications currently or previously taken and possible
associated nutrition-related side effects (anorexia, change in taste of foods,
inability to tolerate certain foods)
 Level of physical activity (field work, etc) and changes in activity level, ability to
perform activities of daily life
 Traditional herbal or other remedies used
134
 Presence of nutrition-related symptoms/signs or side effects including: weakness,
weight loss, anorexia, nausea, abdominal pain, diarrhea, fever, thrush, anemia,
oral lesions or pain, dysphagia
 Normal patterns of food intake and any recent appetite changes, use 24-hour
recall method if time allows
 Patient history or current substance abuse (alcohol, drugs)
 Any psychological considerations that might influence food intake (fear,
depression, hopelessness, suicidal tendency)
 Any family or social factors that might influence food intake (stigma, neglect,
family violence, family alcohol abuse, food availability or intra-familial food
distribution, food taboos, inadequate nutritional knowledge, inadequate
assistance with household duties)
 Conduct directed physical exam.
 Measure and record height and weight. Compare weight to previous weight if
available.
 Calculate BMI, and determine if measurements are within acceptable parameters:
 BMI = weight (kg) divided by height (m2) (see Table 33)
 Normal BMI is 18.5–24.9 kg/m2
 Identify or rule out AIDS wasting syndrome (10% weight loss from baseline body
weight with chronic diarrhea or weakness and fever for one month or more, in the
absence of illness other than HIV infection).
 Identify typical ARV-related changes in body shape (lipodystrophy or changes in fat
deposits and lean muscle distribution).
 Review most recent lab results to rule out anemia.
 Identify any other conditions that could influence nutritional status (OIs, psychological
disorders).

Schedule next appointment (keep in mind that nutritional assessment should be
repeated at least every 3 months for asymptomatic patients and every 2 months for
symptomatic patients):
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Document nutrition assessment and any other findings, actions, and discussions
in patient record; document referrals for additional nutritional support
 Complete all relevant registers as per national guidelines

Complete any nutrition monitoring forms and checklists.
135
Appendices
 Appendix C: How to do a 24-hour dietary recall
 Appendix D: Patient nutrition management form (adult)
 Appendix E: Nutritional assessment tool for PLWHIV
Table 32: Modern medications and recommended food intakes and side effects of
ARVs
Medication
(ARV)
Abacavir
(ABC) NRTI
Didanosine
(ddl) NRTI
Lamivudine
(3TC) NRTI
Food
recommendations
Avoid
Nausea, vomiting, fever, allergic
reaction, anorexia, abdominal pain,
diarrhea, anemia, rash, hypotension,
pancreatitis, dyspnea, weakness
and insomnia, cough, headache
Can be taken without
regard to food
Take 30 minutes
before or 2 hours
after eating. Take
with water only
Can be taken without
regard to food
Possible side effects
Alcohol, juice,
antacids
containing
aluminum or
magnesium
Anorexia, diarrhea, nausea,
vomiting, pain, headache,
weakness, insomnia, rash, dry
mouth, loss of taste, constipation,
stomatitis, anemia, fever, dizziness,
pancreatitis; do not take with antacid
containing aluminum or magnesium
Alcohol
Nausea, vomiting, headache,
dizziness, diarrhea, abdominal pain,
nasal symptoms, cough, fatigue,
pancreatitis, anemia, insomnia,
muscle pain, rash.
Limit alcohol
Nausea, vomiting, diarrhea,
peripheral neuropathy, chills and
fever, anorexia, stomatitis, anemia,
headaches, rash, bone marrow
suppression, pancreatitis. May
increase the risk of lipodystrophy.
Stavudine
(d4T) NRTI
Can be taken without
regard to food
Tenofovir
(TDF) NRTI
Take with a meal
Abdominal pain, headache, fatigue,
dizziness
Zidovudine
(AZT) NRTI
Better to take without
food, but if it causes
nausea or stomach
problems, take with a
low-fat meal. Do not
take with a high-fat
meal.
Alcohol
Anorexia, anemia, nausea, vomiting,
bone marrow suppression,
headache, fatigue, constipation,
fever, dizziness, dyspnea, insomnia,
muscle pain, rash
Efavirenz
NNRTI
Can be taken with
food, but do not take
Alcohol
Elevated blood cholesterol levels,
elevated triglycerides levels, rash,
136
Medication
(ARV)
Food
recommendations
Avoid
with a high fat meal
Nevirapine
(NVP)
NNRTI
Can be taken without
regard to food
Indinavir
(IDV) PI
Take on an empty
stomach, one hour
before or two hours
after a meal. Or take
with a light, non-fat
meal. Take with
water. Drink at least
1500 ml of fluids aily
to prevent kidney
stones.
Possible side effects
dizziness, anorexia, nausea,
vomiting, diarrhea, dyspepsia,
abdominal pain, flatulence
St John’s wort
Nausea, vomiting rash, fever,
headache, skin reactions, fatigue,
stomatitis, abdominal pain,
drowsiness, paresthesia; high
hepatoxicity
Grapefruit.
St John’s wort.
Nausea, abdominal pain, headache,
kidney stones, taste changes,
vomiting, regurgitation, diarrhea,
insomnia, ascites, weakness,
dizziness. May increase the risk of
lipodystrophy.
Lopinavir
(LPV) PI
Can be taken without
regard to food
St John’s wort
Abdominal pain, diarrhea,
headaches, headache, regard to
food weakness nausea; may
increase the risk of lipodystrophy
and diabetes
Nelfinavir
(NFV) PI
Take with meal or
light snack
St John’s wort
Diarrhea, flatulence, nausea,
abdominal pain, rash; may increase
the risk of lipodystrophy
Ritonavir
(RTV) PI
Take with meal if
possible
St John’s wort
Nausea, vomiting, diarrhea,
hepatitis, jaundice, weakness,
anorexia, abdominal pain, fever,
diabetes, headache, dizziness; may
increase the risk of lipodystrophy
Saquinavir
(SQV) PI
Take with meal or
light snack; take
within two hours of a
high fat and high
calcium meal
Garlic
supplements, St
John’s wort
Mouth ulceration, taste changes
nausea, vomiting, abdominal pain,
diarrhea, constipation, flatulence,
weakness rash, headache; may
increase the risk of lipodystrophy
From: Pronsky, Z., S.A. Meyer, and C. Fields-Gardner, HIV Medications Food Interactions, 2001.
Nerad, J., M. Romeyn, E. Silverman, J. Allen-Reid, D. Dietrich, J. Merchant, V. Pelletier, D. Tinnerello,
and M. Fenton, “General Nutrition Management in Patients Infected with Human Immunodeficiency
Virus.” Clinical Infectious Diseases. 2003:36.
“Optimizing Anti-HIV Medications,” The Cutting Edge, 2001. [www.tceconsult.org]
WHO. Scaling Up Antiretroviral Therapy in Resource-Limited Settings: Treatment Guidelines for a Public
Health Approach. 2003 Revision. Geneva, December 2003.
137
Table 33: Body mass index (BMI): Adults and adolescents
Vertex42, Spreadsheet Templates, Calculators, and Calendars, The Guide to Excel in Everything.
Available at: http://www.vertex42.com/ExcelTemplates/Images/body-mass-index-chart.gif
138
SOP 23: Determine level of nutritional support needed
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose

To determine appropriate level of nutritional support required according to national
guidelines for nutrition and HIV and as part of an integrated HIV service package.
Responsibility
 Physician, clinical officer, or nurse
 Other health worker
 Nutrition counselor

Peer educators, patient advocates, and community support workers
Supplies
1. Counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, nutrition register, peer
education register, follow-up/default register, etc) as per national guidelines
3. Equipment/supplies:
a. Adult weighing scale, calculator to determine BMI
4. Nutrition counseling materials as teaching aids and for distribution to patients
5. List of agencies that provide nutrition services by referral
Procedure
 If all findings within normal limits based on nutritional assessment (see SOP 22),
collaborate with patient and family to prepare a realistic patient nutrition plan to
maintain continued adequate nutrition intake, or refer for nutrition counseling.
 Encourage all adults with HIV to become actively involved in monitoring their own
nutritional status.
 If documented AIDS wasting syndrome or BMI extremely outside normal range, meet
with partner or family and schedule urgent joint medical and nutrition consultation.
 Schedule appointment for follow up medical and/or nutritional consultation and food
supplementation if:
 BMI less than 18.5 or unintended weight loss of 6–7 kg in one month regardless
of BMI
 Patients not on ART with weight loss 10% or more within 2–3 months (to consider
139
ART initiation)
 Patients with weight loss more than 5% of baseline weight within past 2–3 months
 If Hgb levels less than 11mg/dl, dispense or recommend iron folate supplementation,
increased consumption of iron-containing dietary sources, assessment of ART
regimen (AZT).
 If changes in body shape or muscle tone noted, consider ARV regimen change or
obtain medical consult to determine if side effects require change in ARV regimen.
 Depending on nutritional status of patient, document request for repeat nutritional
assessment and weight measurement at least every 3 months for asymptomatic
patients and every 2 months for symptomatic patients.
 Identify through discussion with patient, partner and family any household food
security issues or other family/socioeconomic factors that could influence nutritional
status.
 Counsel or refer to address household or community nutrition or food security
barriers identified, and to assist with linkages to food supplementation programs or
other available nutrition improvement programs and resources.

Schedule next appointment (keep in mind that nutritional assessment should be
repeated at least every 3 months for asymptomatic patients and every 2 months for
symptomatic patients):
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Record appointment in follow-up register
 Document:
 Document nutrition assessment and any other findings, actions, and discussions
in patient record; document referrals for additional nutritional support
 Complete all relevant registers as per national guidelines
 Complete any nutrition monitoring forms and checklists
140
SOP 24: Develop nutrition care plan
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To develop individualized patient nutrition care plan according to national guidelines
for nutrition and HIV and as part of an integrated HIV service package.
Note to health workers: all clinical staff should ensure that they have an
understanding of factors influencing nutrition and nutrition intake in their HIV patients,
local food preferences and food preparation methods, cultural norms that influence
household food distribution, local food availability and affordability (“purchase power”).
Responsibility
 Physician, clinical officer, or nurse
 Other health worker
 Nutrition counselor

Peer educators, patient advocates, and community support workers
Supplies
1. Counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, nutrition register, followup/default register, etc) as per national guidelines
3. Equipment/supplies:
a. Adult weighing scale, calculator to determine BMI
4. Nutrition counseling materials as teaching aids and for distribution to patients
5. List of agencies that provide nutrition services by referral
Procedure
 Support PLHIV to eat nutritious diet and maintain or gain weight by:
 Increasing amount and frequency of food consumed that are rich in
energy/calories, protein, fats and micronutrients
 Eating between-meal snacks when possible, even if this is not cultural norm
 Taking vitamin supplements if recommended and available
 Adjust food intake to correspond with food-drug interactions and food
141
requirements of ART and other HIV-related drugs (some ARVs should be taken
with food, iron supplements should not be taken with fiber-rich foods, etc)
 Encourage family members to actively observe patient’s nutritional status and provide
support for improved dietary intake.
 Assure that individual nutrition plan addresses specific household or community food
security barriers identified.
 Actively assist with referrals and linkages to food supplementation programs or other
community-available nutrition improvement programs and resources.
 Consult with or refer to nutritionist or nutrition counselor to assure receipt of above
nutrition planning if appropriate and available.
Advise and discuss with patients, and their families, other factors that may affect
nutritional and overall health status
 Recommend adequate water intake (8 glasses/day). All drinking water and water
used to swallow medicines should be boiled or filtered.
 Discuss practices that may interfere with food intake or absorption including alcohol
consumption, smoking or chewing tobacco, illegal drug use, excessive tea, coffee or
soft drinks.
 Discuss basic concepts of food and water safety, personal hygiene (hand washing
before eating or handling food, wash fresh fruits and vegetables in clean water,
thorough cooking of meats and safe food storage).
 Recommend regular physical activity to promote body strength and prevent loss of
muscle mass and tone.
 If living in hookworm-endemic area, recommend semi-annual de-worming treatment
for all household members, except women in the first trimester of pregnancy.

Schedule next appointment (keep in mind that nutritional assessment should be
repeated at least every 3 months for asymptomatic patients and every 2 months for
symptomatic patients):
 Schedule earlier appointment if required for follow-up of problems identified during
the visit
 Document:
 Document nutrition assessment and any other findings, actions, and discussions
in patient record; document referrals for additional nutritional support
 Complete all relevant registers as per national guidelines
 Complete any nutrition monitoring forms and checklists
142
Mental Health
Background
Purpose of SOPs 25, 26 and 27 is to support the assessment of patient mental health
and determine the appropriate level of mental health/psychosocial support required as
part of comprehensive care, treatment and support to adults with HIV.
Mental health and HIV are closely interlinked. Mental health problems, including
substance abuse, are associated with increased prevalence of HIV and can interfere
with treatment. Conversely some mental disorders (HIV encephalopathy, depression,
mania, cognitive impairment, and HIV-Associated Dementia) occur as a direct result of
HIV infection. Also, some OIs and some ARVs can have side effects that influence
psychiatric and mental health status.
Alcohol/substance abuse is considered mental health disorders. Screening for
substance use is particularly important in HIV-infected patients because both are risk
factors for acquisition and transmission of HIV infection. Addressing alcohol/substance
use can help patients improve adherence to HIV medications and adopt risk-reduction
behaviors, such as practicing safer sex.
Timely diagnosis and treatment of common mental health problems in HIV-infected
individuals, including alcohol abuse and its consequences, and referral to specialized
mental health and psychosocial support services when available presents an
opportunity to improve the health and well-being of people with HIV. Mental health
services should be an integral part of comprehensive HIV services, with close
collaboration at all levels to facilitate coordinated action among health services and
community-based resources.
Definitions
 Mental health refers to a psychological or emotional state of an individual.
 Mental illness is any disease or condition affecting the brain that significantly
influences or disrupts a person's thinking, feeling, mood, ability to relate to others and
daily functioning.
 Psychosocial support: The counseling and support that is provided to address the
range of social and psychological needs of families affected by HIV.
Policy
1. Management of individuals with HIV infection should be based on a family-care
model; the multidisciplinary team should assess the PLHIV in the context of the
family and ensure family members are linked to appropriate care and treatment
(including community psychosocial services as well as healthcare services).
2. Patients with HIV and their family members should be referred to other health
services or community services as needed. Care should be coordinated as much
as possible to reduce the burden of visits.
143
3. A chronic care model should be utilized so that clients are seen regularly and
routinely for monitoring and health promotion activities as well as seen for episodic
care in the event of acute illness.
4. A multidisciplinary team approach should be utilized for the care of clients living with
HIV. Teams may include a nurse, prescribing clinician, pharmacist, counselor,
social worker, community health workers, and others.
Responsibility at health facility
 A single individual should be assigned at each health facility to ensure all services
meet or exceed national policies, practices and guidelines. This individual should
also establish standards where no local or national standards exist and supervise
psychosocial support and family-centered care.
 Psychosocial support services are provided by all health workers.
144
SOP 25: Conduct mental health assessment
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To conduct mental health assessment as part of an integrated HIV service package.
Responsibility
 Physician, clinical officer, or nurse
 Other health worker
 Mental health and/or psychosocial support workers
 Social workers
 Peer educators
 Patient advocates
 Community support workers
Supplies
1. Counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, follow-up/default register,
etc) as per national guidelines
3. Equipment/supplies:
a. Mental health/psychosocial referral forms
b. Mental health status checklists
4. Mental health counseling materials as teaching aids and for distribution to patients
5. List of agencies that provide mental health services by referral
Procedure
 Greet client and observe overall affect, appropriateness of dress, hygiene/personal
grooming.
 Review medical records and/or referral forms for documented history of preexisting
mental health problems and previous treatment interventions.
 Conduct directed patient history to assess:
 Date(s) of previous mental health assessments and diagnoses if any
 Pre-existing long-term decreased mental status such as mental retardation
145
 Mental health-related medications currently or previously taken and possible
associated side effects
 Level of physical activity (field work, etc) and changes in activity level, ability to
perform activities of daily life
 Presence of mental health-related symptoms/signs including: weight loss,
anorexia, changes in affect or mood swings (affective lability), excessive worry,
sleep disturbances, changes in sexual desire or habits, decreased attention span
or concentration
 Traditional herbal or other remedies used
 History of or current substance abuse (alcohol, drugs)
 Any psychological considerations that might influence mental status (the impact of
HIV diagnosis, living with a chronic life-threatening illness, fear of inability to cope
with complicated visit schedule and treatment regimens, fear of shortened life
expectancy/death, concern over stigma and loss of social support depression,
hopelessness, suicidal tendency)
 History of disinhibition, often substance abuse-related (sexual contact with multiple
partners, abusive sexual practices, unprotected sex or low use of condoms)
 Any family or social factors that might influence mental health (stigma, neglect,
family violence (see Table 34), family alcohol abuse, inadequate social support)

Schedule next appointment:
 Schedule earlier appointment if required for follow-up of issues identified during
the visit
 Record appointment in follow-up register
 Document:
 Document mental health assessment and any other findings, actions, and
discussions in patient record; document referrals for additional mental health
support
 Complete all relevant registers as per national guidelines
 Complete any mental health/psychosocial monitoring forms, mental health status
checklists, as well as any referral forms
146
Table 34: Common indications for domestic violence mental health care for
people with HIV



Common
Presenting
Problems and
History in
Patients
Involved in
Domestic
Violence












Behavioral
Cues of
Domestic
Violence
Victims









Batterer’s
History and
Behavior





Stress and anxiety disorders including PTSD and panic attacks
Alcohol or substance dependence or use
Insomnia
Eating disorders
Fatigue, malaise, and vague or psychosomatic complaints
Chronic pain
Severe headaches
Depression
Trauma-related injuries
Suicidal ideation or attempts
Relationship problems
Exacerbation of chronic illnesses (e.g., asthma, migraines)
Change in appointment pattern
Flat or incongruent affectation
Fearfulness toward partner
Apologizes for or rationalizes partner’s behavior (even non-abusive
behavior)
Bases plans and decisions on what partner wants rather than on
his/her own wishes
Performs degrading, inhumane, or inappropriate tasks
Refers to partner’s temper frequently
Focuses on how he/she harmed partner
Flees from home or seeks shelter frequently
Suicide attempts
Intoxication, alcoholism, drug use
Aggressive or abusive toward partner, practitioner, or other staff
Overly attentive to partner
Cancels partner’s appointments
Aggressively presents self as victim
Visible defensive injury pattern
Refuses/resents needed medical or mental health care for partner
From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the
Primary Care Practitioner.
147
SOP 26: Conduct mental status examinations
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To conduct mental status and physical examinations (with focus on cognitive/motor
and substance abuse related impairments) as part of an integrated HIV service
package.
Responsibility
 Physician, clinical officer, or nurse
 Other health worker
 Mental health and/or psychosocial support workers
 Social workers
 Peer educators
 Patient advocates
 Community support workers
Supplies
1. Counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, follow-up/default register,
etc) as per national guidelines
3. Equipment/supplies:
a. Mental health/psychosocial referral forms
b. Mental health status checklists
4. Mental health counseling materials as teaching aids and for distribution to patients
5. List of agencies that provide mental health services by referral
Procedure
 Conduct directed mental status examination with focus on:
 General assessment: appearance, behavior, attitude, speech
 Affective impairment:
 Apathy, irritability, mania (heightened self-esteem or grandiosity, decreased
need for sleep, excessive often inappropriate speech (“flight of ideas”), anxiety
(excessive worry, feelings of loss of control, fear of rejection/isolation/death),
148
memory deterioration
 Insight, judgment, daily functioning: adequate understanding of HIV diagnosis
and progression of illness, risk of HIV transmission to others, medication and
visit adherence
 Mood: sadness, depression, ability to enjoy life, anxiety, irritability, suicidal or
homicidal ideation, violent urges or actions
 Behavioral impairment: psychomotor changes (slowed speech or response time)
 Substance-abuse related impairment: blackouts, retrograde amnesia (inability to
remember events that occurred when under influence of alcohol or drugs),
symptoms or signs of alcohol or drug withdrawal when patient attempts withdrawal
of abused substance (tremors, extreme anxiety, visual/auditory hallucinations,
psychomotor agitation, seizures)
 Conduct directed physical exam with focus on:
 Cognitive impairment: decline in memory, reasoning, judgment, concentration,
and problem solving: inability to remember simple word sequences or perform
simple tasks, to accurately identify date, year, day of week (temporal memory);
decreased verbal fluency (decreased conversation or inappropriate comments)
hallucinations or delusions (hearing voices), nightmares, paranoid ideation
 Motor impairment: unsteady gait, loss of balance, leg weakness, tremors,
hypoactive or hyperactive reflexes, nystagmus or other abnormalities of eye
motion, neurologic abnormalities (tremors, myoclonus, asterixis (abnormal tremor
or involuntary jerking movements) nystagmus, ataxia, decreased sensation to
pinprick or other stimulus, cranial nerve palsy)
 Substance-abuse related impairment: ascites, skin changes suggestive of
alcohol related vitamin deficiency (Vitamin B12/folate deficiency), malnutrition,
muscle wasting, peptic ulcer, gastritis
 Review recent CD4 count or order to determine level of immunosuppression:
 CD4 cell counts from 200 to 500/microL: HIV-associated cognitive and motor
disorders are common
 CD4+ count falls to less than 200 cells/microL: rule out AIDS dementia complex
or HIV associated dementia
 CD4 cell counts <200/microL: CNS mass lesions common. rule out OIs and
AIDS-associated tumors, such as primary CNS lymphoma
 Review lab results or order lab tests to rule out anemia, electrolyte or glucose
imbalances, liver enzyme abnormalities, syphilis
 Identify any other conditions or HIV-related central nervous system disorders that
could influence mental status:
 OIs (including toxoplasmosis, cryptococcosis, lymphoma, progressive multifocal
leukoencephalopathy (PML)), lymphoma
149
 Psychological disorders: encephalopathy, depression, mania, cognitive
disorder, HIV-associated dementia
 Review current ARV or other HIV and non-HIV related medication use and timing
of occurrence of possible medication side effects:
 Determine if medication type(s) or schedule need to be adjusted/changed to
control or diminish psychiatric symptoms or side effects, request consultation if
required (see Tables 35 and 36)
 If traditional herbal medications or treatments used, consider possibility of
psychiatric side effects/interactions with prescribed medications

Schedule next appointment:
 Schedule earlier appointment if required for follow-up of issues identified during
the visit
 Record appointment in follow-up register
 Document:
 Document mental health assessment and any other findings, actions, and
discussions in patient record; document referrals for additional mental health
support
 Complete all relevant registers as per national guidelines
 Complete any mental health/psychosocial monitoring forms, mental health status
checklists, as well as any referral forms
150
Table 35: Neuropsychiatric side effects of selected medications used in HIV
disease
Drug
Side Effects
Acyclovir
Visual hallucinations, depersonalization, tearfulness, confusion,
hyperesthesia, hyperacusis, thought insertion, insomnia
Amphotericin B
Delerium, peripheral neuropathy, diplopia
Lactam antibiotics
Confusion, paranoia, hallucinations, mania, coma
CTX
Depression, loss of appetite, insomnia, apathy
Cycloserine
Psychosis, somnolence, depression, confusion, tremor, vertigo, paresis,
seizure, dysarthria
Didanosine
Nervousness, anxiety, confusion, seizures, insomnia, peripheral
neuropathy
Efavirenz
Nightmares, depression, confusion
Foscarnet
Paresthesias, seizures, headache, irritability, hallucinations, confusion
Interferon
Depression, weakness, headache, myalgias, confusion
INH
Depression, agitation, hallucinations, paranoia, impaired memory,
anxiety
Lamivudine
Insomnia, mania
Methotrexate
Encephalopathy (at high dose)
Pentamidine
Confusion, anxiety, lability, hallucinations
Procarbazine
Mania, loss of appetite, insomnia, nightmares, confusion, malaise
Quinolones
Psychosis, delirium, seizures, anxiety, insomnia, depression
Stavudine
Headache, asthenia, malaise, confusion, depression, seizures,
excitability, anxiety, mania, early morning awakening, insomnia
Sulfonamides
Psychosis, delirium, confusion, depression, hallucinations
Thiabendazole
Hallucinations, olfactory disturbance
Vinblastine
Depression, loss of appetite, headache
Vincristine
Hallucinations, headache, ataxia, sensory loss
Zalcitabine
Headaches, confusion, impaired concentration, somnolence, asthenia,
depression, seizures, peripheral neuropathy
Zidovudine
Headache, malaise, asthenia, insomnia, unusually vivid dreams,
restlessness, severe agitation, mania, auditory hallucinations, confusion
From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the
Primary Care Practitioner.
151
Table 36: Interactions between HIV-related medications and psychotropic
medications: indications and contraindications
Medication
Contraindicated
Possible Dose
Adjustment
Fluoxetine and fluvoxamine Carbamazepine,
may increase PI
phenobarbital, phenytoin
concentration and toxicity.
levels rise: monitor levels
Carbamazepine,
and adjust prn.
phenobarbital, phenytoin,
primidone, St. John’s wort
reduce level of PI, and
concurrent use should be
avoided. Avoid pimozide if
possible.
Use With Caution
Amprenavir
Alprazolam,
diazepam,
midazolam,
triazolam, zolpidem
Clarithromycin
None identified
St. John’s wort may
decrease level of
clarithromycin.
Carbamazepine level
rises: monitor level and
adjust prn. Initial dose of
benzodiazepines (i.e.,
alprazolam, midazolam)
should be reduced, as
clarithromycin may
increase levels.
Delavirdine
Alprazolam,
midazolam,
triazolam
Fluoxetine, fluvoxamine
and nefazodone may
increase NNRTI level and
increase toxicity.
Carbamazepine,
phenobarbital, phenytoin,
St. John’s wort can lower
delavirdine levels: avoid
concurrent use if possible.
Avoid pimozide if possible.
Carbamazepine levels
may rise: monitor and
adjust prn.
Didanosine
(ddI)
None identified
Gabapentin levels
decreased by antacid: ddI
should be given 2 hours
before or after.
Methadone decreases
ddI: consider increased
dose.
Efavirenz
Alprazolam,
diazepam,
midazolam,
pimozide, triazolam
Fluoxetine, fluvoxamine,
and nefazodone may
increase NNRTI level and
increase toxicity. St. John’s
wort may decrease
efavirenz levels and should
be avoided.
Methadone levels
decreased: may need to
increase dose.
Carbamazepine levels
may rise: monitor and
adjust prn.
Fluconazole
None identified
None identified
Carbamazepine and
phenytoin levels rise:
monitor level and
decrease dose prn. Due
152
Medication
Contraindicated
Use With Caution
Possible Dose
Adjustment
to CNS effects, may need
to decrease dose of
benzodiazepines (i.e.,
alprazolam, midazolam,
triazolam), methadone, or
zolpidem. Levels of
amitryptyline and
nortriptyline may rise:
monitor and adjust prn.
Indinavir
Diazepam,
midazolam, St.
John’s wort,
triazolam, zolpidem
Fluoxetine, fluvoxamine,
and nefazodone increase
PI level and increase
toxicity. Carbamazepine,
phenobarbital, phenytoin,
and primidone reduce
indinavir level. Avoid
pimozide if possible.
Carbamazepine level
rises: monitor and lower
dose prn.
Ketoconazole
Alprazolam,
clonazepam,
diazepam,
midazolam,
triazolam
None identified
Carbamazepine and
ethosuximide levels rise:
monitor toxicity and lower
dose if necessary.
Lamivudine
None identified
None identified
None identified
Lopinavir/
Ritonavir*
Alprazolam,
buproprion,
clorazepate,
clozapine,
diazepam,
estazolam,
flurazepam,
midazolam,
pimozide, St.
John’s wort,
triazolam, zolpidem
Fluoxetine, fluvoxamine,
and PI levels may
increase. Mexiletine levels
rise and may cause greater
cardiac/neurologic toxicity:
use with caution.
Phenobarbital and
primidone levels may rise
and PI level fall: avoid
concurrent use if possible.
Desipramine levels may
rise significantly: consider
50% lower dose.
Meperidine and
methadone levels
decrease: may need
increased dose.
Carbamazepine,
clonazepam, nefazadone,
and sertraline: initial dose
should be reduced 70%.
Trazodone levels may
increase: start low.
Phenothiazines, SSRIs,
and TCAs should have
initial dose reduced by
50% and be monitored
closely for toxicity.
Valproic acid, phenytoin
doses may need to be
higher. Ethosuximide
level rises: may need to
lower dose.
153
Medication
Contraindicated
Possible Dose
Adjustment
Fluoxetine and fluvoxamine None identified
may increase PI level.
Carbamazepine,
phenobarbital, phenytoin,
primidone may decrease
PI: avoid concurrent use if
possible. Avoid pimozide if
possible.
Use With Caution
Nelfinavir
Diazepam,
midazolam, St.
John’s wort,
triazolam, zolpidem
Nevirapine
St. John’s wort
Fluoxetine and fluvoxamine Methadone levels
may increase NNRTI level. lowered: may need higher
dose. Carbamazepine
levels rise, PI level may
drop: avoid concurrent
use if possible.
Pyrimethamine
Lorazepam
increases risk of
hepatic toxicity
(monitor LFTs).
None identified
None identified
Rifabutin and
Rifampin
None identified
None identified
Methadone level
decreases and higher
dose may be needed.
Carbamazepine,
phenytoin, valproic acid
levels may decrease:
may need to increase
dose based upon levels.
Ritonavir
Alprazolam,
buproprion,
clorazepate,
clozapine,
diazepam,
estazolam,
flurazepam,
midazolam,
pimozide, St.
John’s wort,
triazolam, zolpidem
Fluoxetine, fluvoxamine,
and PI levels may
increase. Mexiletine levels
rise and may cause greater
cardiac/neurologic toxicity:
use with caution.
Phenobarbital and
primidone levels may rise
and PI level fall: avoid
concurrent use if possible.
Desipramine levels may
rise significantly: consider
50% lower dose.
Meperidine and
methadone levels
decrease: may need
increased dose.
Carbamazepine,
clonazepam, nefazadone,
and sertraline: initial dose
should be reduced 70%.
Trazodone levels may
increase: start low.
Phenothiazines, SSRIs,
and TCAs should have
initial dose reduced by
50% and be monitored
closely for toxicity.
Valproic acid, phenytoin
doses may need to be
154
Medication
Possible Dose
Adjustment
higher. Ethosuximide
level rises: may need to
lower dose.
Contraindicated
Use With Caution
Saquinavir
Diazepam,
midazolam, St.
John’s wort,
triazolam, zolpidem
Fluoxetine and fluvoxamine
may increase PI level and
toxicity. Phenobarbital and
primidone can lower PI:
avoid concurrent use if
possible. Avoid pimozide if
possible.
Carbamazepine level
rises (may need to lower
dose prn) and PI falls
when co-administered.
Stavudine
None identified
None identified
None identified
Zalcitabine
(ddC)
None identified
Disulfuram and phenytoin
may increase risk for
peripheral neuropathy.
None identified
Zidovudine
None identified
Methadone and valproic
acid increase zidovudine
levels: monitor for toxicity.
None identified
From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the
Primary Care Practitioner.
155
SOP 27: Develop mental health care plan
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To develop an individualized patient mental health care plan based on integrated
findings from mental status exam, physical exam and lab results, as part of an
integrated HIV service package.
Responsibility
 Physician, clinical officer, or nurse
 Other health worker
 Mental health and/or psychosocial support workers
 Social workers
 Peer educators
 Patient advocates
 Community support workers
Supplies
1. Counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, follow-up/default register,
etc) as per national guidelines
3. Equipment/supplies:
a. Mental health/psychosocial referral forms
b. Mental health status checklists
4. Mental health counseling materials as teaching aids and for distribution to patients
5. List of agencies that provide mental health services by referral
Procedure
 Based on results of mental status exam, physical exam, laboratory parameters and
other findings, determine need for:
 Initiation of ART (if findings indicate a new clinical stage 3 or 4 condition such as
HIV encephalopathy)
 Initiation of other medical treatment for specific psychiatric condition/mental illness
(antipsychotics, antidepressants, antianxiety agents), see Table 37
156
 Change in HIV-related medication(s)
 Substance abuse treatment/counseling, or routine mental health counseling
 Psychosocial support for patient and family
 Depending on mental health status of patient, treat or request medical or psychiatric
consultation to further assess and treat conditions diagnosed, especially in
symptomatic patients.
 If alcohol abuse/dependence, substance abuse, or family violence documented,
consider family consultation to determine need for active intervention to prevent or
address alcohol abuse-associated family violence or other harmful behaviors. Refer
to alcohol abuse counselor or program if available to develop a realistic plan for
abstinence/withdrawal from abused substance.
 Prepare a realistic patient mental health plan based on assessment and available
support services.
 Discuss mental health findings, options and follow-up actions required with patient
and family:
 Provide reassurance, and provide or refer for counseling and psychosocial support
sources for patient, partner and family
 Explain proposed drug treatment of mental illness and/or underlying medical
condition(s) diagnosed
 Encourage active family participation in improving patient’s mental status and
psychosocial well being
 Encourage patient to remain physically, mentally, and socially active as long as
possible

Schedule appointment:
 For follow up mental health consultation visit(s) if required
 For follow up psychosocial assessment visit and services if required
 With mental health appointments, it continue to be important to monitor
adherence and missed appointments to avoid loss to follow up
 Document:
 Document mental health assessment and any other findings, actions, and
discussions in patient record; document referrals for additional mental health
support
 Complete all relevant registers as per national guidelines
 Complete any mental health/psychosocial monitoring forms, mental health status
checklists, as well as any referral forms
157
Table 37: Drugs used to target symptoms of AIDS dementia complex
Category
Psychostimulant
agents (for
psychomotor
slowing, apathy,
and attention
deficits)
Drug
Dosage
Dextroamphetamine
5–15 mg/day
Methylphenidate
Initially 5–10 mg every
morning; up to 3-times-aday dosing; maximum
dose: 30–45 mg/day
Pemoline
18.75 -75 mg every day;
once-a-day dosing
Antipsychotic
agents
Haloperidol
0.5–2 mg/day; up to tid
Risperidone
0.5 -1 mg; up to tid
Antimanic agents
Lithium carbonate
600–1,200 mg/day up to
blood levels of 0.6–1.2
mEq/L.
Valproic acid
250 mg tid; titrate up to
blood level of 50–100
mg/mL
Carbamazepine to
4–12 µg/mL
200 mg bid; titrate up
Gabapentin
100 mg tid; titrate to effect
Olanzapine
2.5 mg qd; titrate up to 10
mg
Paroxetine
10–20 mg q hs
(up to 50 mg)
Sertraline
25–50 mg q am
(up to 200 mg)
Fluoxetine
10–20 mg q am
(up to 60 mg)
Citalopram
10–20 mg q am
(up to 40 mg)
Desipramine
25 mg bid; titrate to 180
ng/mL
Trazodone
50–100 mg hs
Antidepressants
(for depression)
Comment
Controlled substances
Use lowest effective
dose to avoid extrapyramidal effects,
anticholinergic effects,
or orthostasis; patients
with AIDS are quite
sensitive
Use with caution;
neurologic side effects
and diarrhea may occur
Use with caution; follow
liver function tests Can
cause leukopenia;
monitor WBC
Most sedating, so hs
dose often preferred
Most activating
Used mainly as a
sleeping aid; can be
calming for agitated
patient
From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the
Primary Care Practitioner.
158
SOP 28: Provide links to additional care sites
Date of creation or
Prepared by:
revision:
Reviewed by:
Approved by:
Purpose
 To determine the need for and manage the process of referral or transfer of patients,
partners, children or other family members within the same facility, between facilities
or levels of care, and to community sources of care and support for services beyond
the scope of care of primary care site.
Responsibility
 Physician, clinical officer, or nurse
 Triage staff
 Administrative staff
 Peer educator
 Patient advocates
 Community support workers
 Volunteers and other designated community members
Supplies
1. Examination and counseling areas that offer adequate privacy
2. Medical record and relevant registers (HIV client register, referral/transfer register,
peer educator registers, follow-up/default register, etc) as per national guidelines
3. Counseling materials as teaching aids and for distribution to patients
4. Two way referral forms and a list of agencies that provide mental health services by
referral
Procedure
Determine the need for referral/transfer, at initial visit and at each monthly clinic
visit
 Assess the patient to determine if additional treatment, care or support is required.
 Referral may be required for:
 HIV testing and counseling for partner, children or other family members
 Antenatal care clinic services if pregnancy occurs
 Maternal and child health clinic for testing of children in the family if not possible to
159
test infants/young children on-site
 Inpatient ward or special services (infectious disease, TB, gynecology, etc)
 Laboratory/radiology for further diagnostic work-up
 Facility-based support services such as peer educators
 Community support organizations
 Transfer may be required if:
 Patient requires chronic care beyond the scope of the primary care site
 Patient requests change of service location because of permanent move/
temporary change in primary household location
 Patient prefers to change treatment site for any other reason
 Determine specific types of referral/transfer required.
 Suggest an appropriate, realistic referral/transfer plan.
 Discuss the referral or transfer plan with the patient.
 Schedule a specific date and time for the patient to report to the referral or transfer
site that is realistic for the patient and family.
 Provide sufficient amount of medication(s) to allow for the referral or transfer to take
place, if required.
 Complete referral form containing reason for referral/transfer, summary of treatment
and care received to date.
 Give a copy of the referral form to the patient/family and instructions to present it on
arrival at the referral/transfer site.
 Discuss with patient and family to determine support required to facilitate
referral/transfer.
 Assist patients with location additional referral support if required.
Notify additional care site of referral/transfer plan and assure adherence to
referral
 Make initial contact with the site for notification of patient referral or transfer using
forms for two-way referral/transfer feedback process.
 Send form to referral site to be returned to your site at time of arrival/treatment of
patient including: date patient arrives for additional continuing treatment, treatment
provided, final treatment outcome.
 Contact the referral/transfer site to check if the patient completed the referral/transfer
utilizing two-way referral/transfer mechanism.
 Check incoming referral reports regularly to assure adherence with referral /transfer,
and that appropriate care was received.
160
 Initiate tracking/follow up process if no return information received within two weeks
to one month depending on circumstances.
 Assure that confidentiality is maintained throughout the referral/transfer process.

Schedule appointment, if appropriate, for routine follow up:
 Record appointment(s) in follow-up register
 Document:
 Document all referrals in patient record
 Complete all relevant registers as per national guidelines
161
Appendices
Appendix A: Patient adherence record form
Folder No:
Date:
/
/
(dd/mm/yyyy)
Treatment was initiated on:
/
/
Duration of treatment:
/
(dd/mm/yyyy)
(months / years)
Begin by telling the patient that, “Most people with HIV have many pills to take at different times
during the day. Many people find it hard to always remember to take their pills. It is important for
me to understand how you are really doing with your medicine. Don’t worry about telling me if
you don’t always take all your doses. I need to know what is really happening, not what you
think I want to hear.”
Self-Reporting
Please mark the client’s response to the following questions.
Question
Yes
No
Do you sometimes find it difficult to remember to take your medicine?
When you feel better, do you sometimes stop taking your medicine?
Thinking back over the past four days, have you missed any of your doses?
Sometimes if you feel worse when you take the medicine, do you stop talking it?
Visual Analogue Scale (VAS)
Ask the client to think back over the past four days and identify the times when he or she either
missed a dose or took it at the wrong time. Show the client a copy of this visual analogue scale,
or an unmarked enlarged version. While placing your finger on the appropriate place, tell the
client that if he or she had taken all medicine doses to point to 10. If the client missed all the
doses, he or she would point to 0 — in the meantime, you move your finger to 0. Now give the
client an opportunity to point out their level of adherence. The health care worker then marks the
visual analogue scale. If the scale is marked off at 4, then the percentage adherence would be
40 percent.
162
0
1
2
3
4
5
6
7
8
9
10
Score:
%
Pill Identification Test (PIT)
Ask the client to inspect each container and its contents. He or she should then tell you the
name of the medication, number of pills to take per dose, the times he or she takes the
medication, and whether there are any additional instructions.
Medication
Knows
the name
(Y / N)
Knows the
number of
pills per
dose (Y / N)
Time the medication is taken
Judged
Morning
Evening
correct
(hour)
(hour)
(Y / N)
Knows any
additional
instruction
Pill Count
 Yes*
Did the client return the medication containers?
 No
*If yes, check that the client only used medication from this container since the date of their last
visit. If leftover medication had been used or an emergency prescription obtained, then the
calculation will be invalid—omit and move to Adherence Assessment.
Dispensed  Returned
% Adherence =
X 100 =

X 100 =
%
Expected to be taken
Adherence Assessment
Self-reporting
VAS
PIT — Client knows
the…
Pill count
Overall adherence
No to all questions
Yes to 1 question
95% or more
Dose, time, and
instructions
95% or more
High
75–94%
Dose and time
75–94%
Moderate
Yes to 2 or more
questions
Less than 75%
Dose only or
confused
Less than 75%
Low
163
Adherence Support Measures
Code
AS01
AS02
AS03
AS04
AS05
AS06
Notes
Treatment preparednes
Treatment buddy or community health work
Home visit
Medication counseling—dosing regimen and
instructions
Medication counseling—show and tell
Medication counseling—safety
AS07
AS08
AS09
AS10
AS11
AS12
Life style inventory
AS13
AS99
Personalized printed medication information
Medication diary
Motivational interviewing
Reminder such as a pill box
Support groups
Printed medication information
Other—please specify under notes
Comments (Insert comments as needed)
Adherence Improvement Plan (Include details of plan agreed on with client)
164
Instructions for completing Patient adherence record form
Background
This tool has been designed to assist pharmacists, pharmacy assistants, nurses and doctors in
the assessment and monitoring of adherence to long term therapies such as ART. The
adherence record should be retained in the client’s medical records for future reference in
planning adherence improvement interventions.
The adherence assessment can be performed routinely. However if this is not possible it is
recommended that adherence be assessed whenever a viral load is performed, treatment
failure is suspected, adherence problems are suspected ,a step-up adherence intervention has
been initiated and/or when a change in regimen is being contemplated.
This medication adherence record is a multi-method tool comprised of four components that had
been previously validated. This approach has been adopted based upon the WHO
recommendation that states, “A multi-method approach that combines feasible self-reporting
and reasonable objective measures is the current state-of-the-art in measurement of adherence
behavior.”
The four sections of the tool include:
5. Self-report
6. VAS
7. PIT
8. Pill count
The tool’s fundamental premise is that the regimen, rather than the individual medicines, is the
unit for assessing adherence. Selective adherence to some but not all of the medications in the
combination regimen means that the intended benefits of combination therapy (pharmacological
synergy) are not achieved, and in the instance of infectious disease, may precipitate resistance.
Basic Methodology
The data elements of this adherence assessment tool must be completed by the health care
worker administering the tool and not the client.
Before assessing the client’s adherence levels, it is important to set the scene by informing the
client that this assessment is not punitive but rather aimed at helping them achieve optimal
adherence. A recommended approach would be to tell the client that:
“Most people with HIV have many pills to take at different times during the
day. Many people find it hard to always remember to take their pills. It is
important for me to understand how you are really doing with your medicine.
Don’t worry about telling me if you don’t always take all your doses. I need to
know what is really happening, not what you think I want to hear.”
165
In the self-report, the health care worker guides clients through a series of questions to which
they respond yes or no. An adherent client will respond no to all questions. This helps validates
responses since ordinarily clients tend to respond yes to any questions posed to them by a
health care professional to please them.
A visual analogue scale has been included to verify the verbal responses. In this question,
clients are asked to rate their adherence to their medication over the past four weeks. The client
then indicates on a graduated scale where they believe their adherence has been during this
period.
The pill identification test begins with the health care personnel familiarizing themselves with
the last prescription that was dispensed. This is then followed by the client being shown a
physical example or photograph of the same brand of the tablet, capsule, or bottle for liquid
preparations that the client had been given in the preceding month —this is key. The client then
attempts to name the product and describes:
 The number of tablets, capsules, and medicine measures that he or she consumes at each
dosing interval.
 The exact time when he or she takes the dose. (As the client describes these times, pay
careful attention to the spontaneity of the response and not merely the correctness on the
dosing times. Probe for further responses.)
 Additional instructions he or she follows when taking the medication such as remembering to
have a meal before taking the dose. (If the client does not provide the correct information use
open-ended questions to verify how they take their doses.)
Wait until the client has completed explaining all of the medications in the regimen before
providing corrective counseling for any medication that requires it.
In the pill count, the returned medication is counted and the percentage adherence is
calculated using the equation provided. Note that the denominator is the amount of medication
that the client is expected to have taken and not the amount that was dispensed.
Detailed Instructions
Folder No:
Date:
/
/
(dd/mm/yyyy)
The folder number and date are recorded to allow copies of the form to be kept in the client’s
folder. Changes in the client’s adherence can also be monitored over time. Ongoing monitoring
of adherence is important as adherence generally tends to decrease with time.
Treatment was initiated on:
/
/
(dd/mm/yyyy)
Duration of treatment:
/
(months / years)
166
Self-Report
Clients tend to answer yes to questions posed to them by their health care provider to please
them. Based upon this observation, the questions have been designed so that an adherent
client gives a no response.
Question
Yes
No
A. Do you sometimes find it difficult to remember to take your medication?
This question aims to test whether there are established dosing cues in
the client’s daily routine.
B. When you feel better, do you sometimes take a break from your
medication?
Clients frequently stop taking their medication when their presenting
health problem has been resolved.
C. Thinking back over the past four days, have you missed any of your
doses?
Try to get the client to think back over the past few days. It may help to
identify a routine daily event such as meals, work, or television
programs watched, and enquire about the nature of that event four days
previously. For example, ask the client what they had for dinner on
Tuesday.
D. Sometimes if you feel worse when you take the medicine, do you stop
taking it?
If the presenting health problem has not produced symptoms or the
problems have been resolved, and there are bothersome side effects
from the medicine, clients find it difficult to rationalize continued
adherence.
Assessing Adherence
Count the number of No answers to questions A through D.
 If all 4 answers are No, then the client is classified as being highly adherent.
 If there is 1 Yes answer, then the client is classified as being moderately adherent.
 Where there are 2 or more Yes answers, the client is classified as having low adherence.
Visual Analogue Scale (VAS)
Ideally, use a laminated visual analogue scale (ruler) that has been enlarged or the scale on the
questionnaire. Whichever form of the scale you use, it is important that you use an unmarked
one. While placing your finger on 10, tell the client to also point to 10 if he or she had taken all
medicine doses. If the client missed all the doses, he or she would point to 0 — in the
meantime, you move your finger to 0. For a client using the visual analogue scale for the first
time, it may help to ask the client to indicate where a theoretical client who managed to take all
the doses would point, then to indicate where the theoretical client who had missed all of his or
her doses would point. Note that during this demonstration we are using the third person. Now
ask the client to think back about the dosing of their medication over the past four days. Having
167
given the client time to reflect ask them to place their finger on the point on the scale (ruler) that
best reflects his or her adherence during this time.
0
1
2
3
4
5
6
7
8
9
10
Score:
%
Now score the percentage on the box as follows if the client chose 4, then the score will be 40
percent.
Pill Identification Test (PIT)
Familiarize yourself with the last prescription that was dispensed to the client. Pay careful
attention to the brand that was dispensed in order to identify the identical product that the client
has been using. Show the client a physical example or photograph of the identical tablet,
capsule, or bottle for liquid preparations that he/she was given in the preceding month.
Ask the client to inspect the contents of each container and its contents, and tell you the
 Medication’s name
 Number of pills to take per dose
 The actual times he or she takes the medication
 If there are any additional instructions relating to the medication such as store in a
refrigerator, take with food, or avoid other medications
Medication
Knows
the name
(Y / N)
Knows the
number of
pills per
dose (Y / N)
Time the medication is taken
Morning
(hour)
Evening
(hour)
Judged
correct
(Y / N)
Knows any
additional
instruction
Note: The grey shaded column is the judgment of the health care worker administering the questionnaire.
 In the left hand column under medication, record the medication that has been assessed—
feel free to use abbreviations, e.g., 3TC, to reduce the amount of writing.
 Ask the client to provide the name of the medication. Record the response by recording a Y
for yes (correct response) and an N for no (incorrect response). If the response is incorrect,
teach him or her the name of the medication. Note — the client’s response to this question is
not included in the adherence assessment.
 Ask clients how many tablets, capsules, or medicine measures they take in the morning and
then in the evening. If their response is correct for both, place a Y in the column; if either or
both of the dosing times are incorrect, place N in the box.
 Now ask the clients to identify the usual time they take their morning and evening doses.
Record the actual times in the boxes provided. As the client describes these times, pay
careful attention to the spontaneity of the response, not only the correctness of
168
responses in terms of the dosing times. If there is hesitation, it may mean that they are
taking their medication at inconsistent times (e.g., 1700h today, then 2000h tomorrow).
Explore with the client whether or not it is possible for them to take their medication at a
consistent time. This is achieved by taking a brief inventory of their daily activities during a
typical week day followed by differences in schedule over weekends. If the times they take
the medication are within reasonable limits (one hour) of the dosing interval, place a Y in the
column; if incorrect, place an N in the column.
Example: If the first dose of a 12-hour regimen is taken at 0700h, then ideally the evening
dose would be 1900h; however, if the client takes their medication any time between 1800h
and 2000h, it is considered acceptable for most medications. If you are uncertain about this,
contact a person knowledgeable in pharmacology.
 Where the regimen is associated with a particular additional instruction, ask the client if there
is anything special that they have to do when taking the dose such as the need to take the
dose before or after a meal. If the client does not provide the correct information use
open-ended questions to verify how they take their doses. If correct, place a Y in the
column; if incorrect, a N.
Wait until the client has completed providing responses on all of the medications in the
regimen before providing corrective counseling for any medication that may be required.
Example:
Time the medication is taken
D4T
Knows
the name
(Y / N)
Y
Knows the
number of
pills per
dose (Y / N)
Y
Morning
(hour)
0715h
Evening
(hour)
2000h
Judged
correct
(Y / N)
Y
Knows any
additional
instruction
Y
3TC
Y
Y
0715h
2000h
Y
Y
Efavirenz
Y
Y
0715h
N
Y
Medication
Pill Count
Did the client return the medication containers?
 Yes
 No
Calculated percentage adherence
Dispensed  Returned
% Adherence =
X 100 =

X 100 =
%
Expected to be taken
 If the client returns the container, then check the yes box; and if the client did not, check the
no box.
 For those clients who have not returned their medication container, skip the pill count
calculation and move directly to the adherence assessment section.
 Check that the client only used medication from this container since the date of his or her last
visit. If leftover medication had been used or an emergency prescription obtained, then the
calculation will be invalid and should not be completed.
169
 Record the quantity dispensed during the last visit in the space that says dispensed.
 Count the remaining tablets and write it in the space that says returned.
 Next count the number of days since the medication has been dispensed. Multiply the
number of days by the prescribed number of tablets to be taken in a day. Example: 2 tablets
twice daily = 2 x 2 = 4 tablets per day for 27 days = 4 x 27 = 108.
 The percentage adherence is then calculated as the number dispensed minus the number
returned which is then divided by the number of tablets the client should have taken.
Example: If 120 were dispensed and the client returned with 17 tablets and the regimen
required 2 tablets twice a day to be taken for 27 days, the percentage adherence is—
120  17
% Adherence =
X 100 =
95%
108
Adherence Assessment
Self-reporting
VAS
PIT — Client knows
the…
Pill count
Overall adherence
No to all questions
Yes to 1 question
95% or more
Dose, time, and
instructions
95% or more
High
75–94%
Dose and time
75–94%
Moderate
Yes to 2 or more
questions
Less than 75%
Dose only or
confused
Less than 75%
Low
Check the results in the columns provided:
 If all the results appear in the same column, e.g., “All No,” “VAS 95 % or more,” “Dose, Time,
and Instructions,” and the pill count was 95 percent or more, then the overall level of
adherence is “High.”
 Although you may not have responses to all the four methods, you can still use this tool.
Remember that each one of these measures indirectly assesses adherence but is slightly
over or under what the adherence really is. So, the more measures that can be recorded, the
stronger the probability that the adherence assessment accurately shows how the client
takes medicine. This multi-method approach provides data from different sources that can be
compared to assess client adherence (triangulation) to verify the true level of adherence.
 At the very minimum you should record the results of the self-report. However, this has a
tendency to measure higher levels of adherence than actually happened.
 When the results do not all line up in a single vertical column
 If they are spread over two columns, take the adherence level of the right hand column
as the estimated adherence.
 If they are spread over three columns, then use the middle level of adherence.
170
Example:
Self-reporting
No to all questions
Yes to 1 question
Yes to 2 or more
questions
95% or more
75–94%
Less than 75%
Dose, time, and
instructions
Dose and time
Dose only or
confused
95% or more
75–94%
Less than 75%
High
Moderate
Low
VAS
PIT – Client knows
the…
Pill count
Overall adherence
Note: We record the level of adherence as High, Moderate, or Low instead of as a percentage.
The percentage is important in a clinical trial; however, in clinical practice, the question we are
trying to answer is whether or not there is sufficient adherence to prevent resistance or whether
adherence support interventions are needed.
 If the level of adherence is high, record it in the clinic record and provide the client with
reinforcement.
 For moderate levels of adherence, discuss the result with the client and continue to measure
adherence levels. If moderate levels of adherence have been observed for three sequential
visits, institute an adherence support measure.
 If a low level of adherence or non-adherence has been observed:
 Refer the client to a pharmacist for a step-up adherence intervention such as motivational
interviewing.
 Monitor CD4 count as per usual and monitor viral load as the client is at risk of
developing resistance.
Adherence Support Measures
Review the clinic records as well as past adherence assessment records and verify with the
clients whether or not they had any additional aids to assist them in remembering to take their
medications and record the menu of measures in the boxes provided by checking off the
appropriate box. It is likely with any given client that more than one of the measures may have
been used.
Code
Notes
AS01
Treatment preparedness
AS02
AS03
Treatment buddy or community health work
AS04
AS05
AS06
Home visit
Medication counseling — dosing regimen and
instructions
Medication counseling — show and tell
Medication counseling — safety
171
Code
Notes
AS07
Life style inventory
AS08
AS09
AS10
AS11
AS12
AS13
Medication diary
AS99
Other — please specify under notes
Motivational interviewing
Reminder such as a pill box
Support groups
Printed medication information
Personalized printed medication information
Tick off the corresponding blocks for those adherence support measures that the client has
been exposed to. The notes section allows for an expanded description of other interventions or
the success or failures of the interventions. This record allows the pharmacist to decide on
adherence support measures in those clients who require an adherence improvement
intervention.
Comments (Insert comments as needed)
The comments section allows the pharmacist to record:
 A more detailed description of any identified adherence barriers
 Counseling points to facilitate incremental counseling
 Any pertinent information that would enrich future adherence counseling or other
improvement interventions
Adherence Improvement Plan (Include details of plan agreed on with client)
This block allows the pharmacist to develop an adherence improvement plans for those clients
who require it. It also serves to record planned future interventions for clients who are being
actively monitored for the need of additional adherence improvement interventions.
Steel, G., J. Nwokike, M. Joshi. Management Sciences for Health (2007). Development of a Multi-Method
Tool to Measure ART Adherence in Resource-Constrained Settings: The South Africa Experience, p 3143
172
Appendix B: Clinical algorithms
Acute Diarrhea (<3 Weeks)
Check vital signs. Is patient severely dehydrated?
Check orthostatics (lying down and standing) and look
for BP drop >15–20 mmHg or ↑pulse > 20
beats/minute
YES
Hx and Exam: duration, onset, stool appearance, bloody/non-bloody,
large/small volume, ABX use, other people affected, N/V, fever, abdominal
pain, frequency?
FEBRILE OR
BLOODY
DIARRHEA
RECENT ABX
USE
If severe,
check HLT,
BUN/Cr, WBC
Stool culture/
analysis
IV fluids
ASAP
Febrile? Bloody?
NO
SALMONELLA:
 Cipro 500 mg BD or Septrin
DS mg BD x 2/52
SHIGELLA:
 Cipro 500 mg BD x 5/7
CAMPYLOBACTER:
 Erythromycin 500 mg BD or
Cipro 500 mg BD x 5/7
AMEBIASIS:
 Flagyl 500 mg TID x 7–10
days followed by Diloxanide
500mg TID x 10 days
FATTY
(FLOATING)
Malabsorption –
check amylase
YES
ABX –
assoc.
diarrhea,
should
resolve
WATERY
DIARRHEA
Consider HIV
enteropathy –
supportive care (bland
foods, no caffeine or
lactose)
C. DIFFICILE:
 Flagyl 500 mg PO
TID x 7–10 days.
NO anti-motility
drugs
For all patients:
 Good hand washing, especially around children
 Boil water
 Avoid raw foods (meat)
STD workup
including
syphilis,
gonorrhea,
chlamydia, HSV
Stool
culture/
O&C
CRYPTOSPORIDIUM:
 Paromomycin 500 mg QID
x 4/52
MICROSPORIDIA:
 Most cannot be tx but can
try albendazole 400 mg BD
x 2–4 wks
CYCLOSPORA:
 Septrin DS 4 tabs OD x
10/7
ISOSPORA:
 Septrin DS 4 tabs OD x
10/7, then 2 tabs OD x 3/52
GIARDIA:
 Flagyl 500 mg TID x 7/7
If culture negative, consider
enteric viruses. Tx w/
supportive care – IVF,
antimotility drugs
If persistent sx, consider stool
AFB stain or blood cultures for
MAC
173
Chronic Diarrhea (3 or more stools/ day for 4 or more weeks)
Hx and Exam: onset, associated sx, weight loss,
abdominal pain, fever, bloody, CD4 count, medications
Assess vital signs. Is pt dehydrated?
Orthostatic? Hypotensive?
NO
YES
Is the diarrhea
bloody?
Does pt look critically ill? Are there
pulmonary sx or exam abnormalities?
NO
YES
NO
Order stool
O&P and
fecal WBC
Any recent ABX use
or hospitalizations
(+ fecal WBC)?
Does stool exam
(culture) clearly
identify Salmonella,
Shigella, or
Campylobacter?
See pg 2 of
algorithm.
Consider CXR
If CXR shows bilateral patchy infiltrates that
are consistent w/ ARDS, strongly consider
admission and tx for strongyloides hyperinfection syndrome, especially if pt has
cutaneous findings (serpiginous lesions)
Treat accordingly.
Salmonella:
 Septrin DS 2 tabs OD x 3/52
Shigella:
 Septrin DS 2 tabs OD x 5/7
Campylobacter:
 Erythromycin 1000 mg OD x 5/7
YES
NO, or stool
culture not
available
Does stool exam
show Entamoeba
YES
w/- fecal WBC?
Treat w/ ivermectin 12 mg OD x
3 days plus supportive care
and fluids. Continue monthly
suppressive tx w/ ivermectin 6
mg or albendazole 400 mg
Tx for E. histolytica:
 Metronidazole 500 mg TD x 10/7, then
paromomycin 500 mg QID x 7/7
NO
MAC → treat empirically:
1. Azithromycin 500 mg OD OR
clarithromycin 500 mg BD
AND
2. Ethambutol 15 mg/kg/day
AND
3. Ciprofloxacin 500 mg BD for
at least 4 wks.
Treatment failure is common.
Tx w/ Septrin DS
2 tabs OD x 3 wks
Septrin DS 2 tabs OD x 5 days
Improvement?
Give IVF
Tx as C. difficile:
 Metronidazole 500 mg
TD x 1/52
 No antimotility drugs
YES
YES
YES
Relapse within 4 wks
NO
Ciprofloxacin 500 mg BD x 5 days
Improvement?
CMV colitis:
1. Treat empirically w/ valgancyclovir
900 mg BD x 3–4 wks
NO
Erythromycin 500 mg BD x 5 days
Improvement?
NO

+
Recheck stool
leukocytes
Is CD4 <50?
174
Chronic Diarrhea (2)
YES
See pg 1 of
algorithm
Is the diarrhea bloody?
NO
Does pt describe bloating/
flatulence?
YES
Tx for giardia:
 Metronidazole 500
mg TD x 5 dys
NO
YES
Does pt have cough, abdominal pain, and
erythematous serpiginous lesions?
NO
Tx for strogyloides:
 ivermectin 12 mg OD x 3 dys
or albendazole 400 mg BD x 5
dys then monthly maintenance
of either ivermectin 6 mg or
albendazole 400 mg
Get stool O&C and fecal WBC
YES
Obvious cause identified on O&C
Treat
accordingly
NO
Septrin DS 1 tab 4x/ day x 10 dys (empiric tx of
Isospora/ Cyclospora)
YES
Improvement?
Continue Septrin DS 1 tab PO OD
NO
YES
Is CD4 <100 w/ abdominal pain
and no fecal WBCs?
Treatment for Cryptosporidiosis:
 Paramomycin 500 mg QID x 14 dys then 500 mg BD
for maintenance. Can use antidiarrheal drugs.
NO
Try albendazole 400 mg BD x 3 wks for
empiric tx of some types of microsporidia.
Improvement?
NO
Ensure pt is
on ARVs
Pt has 1) untreatable microsporidia, 2) viral chronic diarrhea,
3) AIDS enteropathy. Offer supportive care – small meals, bland
food, avoid caffeine/ lactose, provide antimotility drugs.
175
Cough < 2 Weeks (page 1)
Hx and Exam:
Pre-existing URI? Current other sx (fever,
SOB)? GERD? Medications?
Cough w/ severe dyspnea:
 Proceed to Page 2 of
Algorithm for Cough < 2
weeks
Cough w/ wheezing:
 Proceed to Page
2 of Algorithm for
Cough < 2 weeks

Dry cough? Afebrile? Normal physical exam?
YES
 Cough suppressants
 Return in 1–2 weeks if
Weight loss?
Hemoptysis?
no improvement
YES
 CXR
 Sputum AFB
+
 Anti-TB
therapy
Febrile? Sputum production?
Crackles?  WBCs?

Consider other
causes, i.e.,
pneumonia and
atypical TB
presentation
Get CXR
Focal Infiltrate:
 Tx as pneumonia w/ Augmentin
Bilateral patchy opacities:
 Tx as PCP (especially if low O2 saturation)
Effusion:
 Tap the fluid and tx accordingly for parapneumonic
effusion vs. TB
Air-fluid level:
 Tx as abscess w/ Augmentin or clindamycin x 3-4
weeks
Improvement
after one week?
Consider empiric antiTB therapy
Routine follow-up
For all patients:
 Smoking cessation
 Ensure patients are on appropriate prophylaxis
176
Cough < 2 Weeks (page 2)
History and Physical Examination
Cough w/ wheezing
Cough w/ severe dyspnea or  O2
saturation (94% or less)
YES
CXR
CXR
Focal Opacity
Suggestive of TB?
Normal
Bilateral
patchy
infiltrates
Start anti-TB therapy
 Treat w/ abx for
pneumonia
 Offer Ventolin
Pneumothorax
Also get surgery consult
for chest tube
inhaler
 Consider dx of asthma
 Offer Ventolin
 Consider a short (3-5 day)
Treat for PCP
course of prednisone
Add steroids if pt has O2 sat < 90%, looks
severely ill or has significant dyspnea
Improvement after 7 days?
YES
 Continue tx course
 Resume PCP prophylaxis
after tx is finished
NO
 Consider change to another regimen or add
doxycycline.
 Also consider other diagnoses, e.g.,
community-acquired pneumonia
177
Cough < 2 Weeks (page 2)
Hx and exam:
Fever, night sweats, weight loss, hemoptysis, GERD sx, sick contacts,
meds?, bronchial breath sounds, crackles, dull to percussion?
Is cough productive?
NO
YES
Pre-existing URI?
Pharyngeal cobblestoning on exam?
Fever?
Sputum production?
YES
Post-nasal drip. Tx
with antihistamines
YES
Discuss GERD,
conservative tx
measures:
  time between
dinner & HS
 
spicy/fatty/acidic
foods
YES
Improvement after
1–2 months?
NO
CXR
Focal
opacity
Normal, or patchy
bilateral opacities
Tx for pneumonia
but consider
atypical coverage
Treat for PCP
Sx worse at night?
Sour taste in mouth?
Cavitations,
effusion, hilar LAD,
military pattern
NO
Routine f/u
Treat for TB
NO
Any newly added
meds (like ACE
inhibitors)?
NO
6 wk trial of PPI or
H2 blocker
YES
Stop medication
Treat as asthma:
YES  Minimize
Wheezing?
Cough worse with exertion?
irritants
 Use albuterol
NO
MDI PRN
For all patients:
Smoking cessation
Crackles on exam?
 JVP?
Leg edema?
S3 or S4 on exam?
 heart size on CXR?
YES
EKG
Treat as CHF:
 Furosemide for diuresis
 Consider ASA/-blocker especially if evidence of
ischemic disease on EKG
178
Chest Pain
Hx and Exam: location, duration, radiation, quality,
associated sx, aggravating/ alleviating factors, past
medical hx, meds, family hx, habits
CP w/cough
No cough
Consider ischemic
disease w/ CHF; get
CXR/EKG. Tx HTN and
lipids if high. Give Lasix if
evidence of volume
overload.
L-sided pain?
Intermittent, worse with
exertion? (angina)
Associated w/
dyspnea, N/V,
diaphoresis?
Radiation into arm face
of neck?
If no suspicion of ischemic
heart disease, proceed to
cough algorithm
ST elevation
EKG +/CXR
ST depression, Q waves,
T wave inversions
Consider admission for
acute MI. ASA, βblockers, nitrates
(unless rt-sided),
morphine, oxygen.
NO
Sx worse at night?
Burning pain?
Sour taste in mouth
Sinus tachycardia or right heart
strain (S1, Q3 or 3)
YES
Consider GERD or
dyspepsia. PPI or H2blocker x 6–8 wks
Admit to hospital. ASA,
β-blockers, nitrates
(unless rt-sided),
morphine, oxygen.
Consider lytic therapy.
Consider PE, admit for
heparin + coumadin.
normal
NO
Consider
EKG
Low voltage on EKG, diffuse ST
elevation, rub on exam
abnormal
Consider coronary
problems (see rt
side of algorithm)
YES
PCP tx w/
Septrin,
steroids
Normal or diffuse patchy
opacities
CXR
focal
Acute pericarditis.
Tx w/ NSAIDs +/steroids
Fever?
Crackles on exam?
↓O2 saturation?
NO
Pain reproducible w/
palpation?
Recent viral URI?
Recent trauma or
overactivity?
YES
Muscular strain
or
costochondritis.
Tx w/ NSAIDs.
Tx for bacterial pneumonia
For all patients:
 If hypotensive, consider PE, esophageal perforation, pneumothorax, pericardial effusion w/ tamponade. Get CXR,
EKG. Admit pt to hospital.
 Smoking, EtOH cessation
179
Headache
Hx and Exam: duration, quality, location, associated sx, neurological sx, fever, good neurological exam, etc.
Common causes of HA identified?
 Hypertension
 Sinus infection
 Migraine
 Cluster
Treat appropriately:
 Tx HTN
 Abx if sinus infection or watch and
wait
 Pain meds, antiemetics for migraine
 Pain meds for cluster HA
YES
NO
Worst HA of life?
YES
Focal neurological findings?
YES
Start toxo treatment
NO
Meningeal signs?
Consider CT head for
subarachnoid hemorrhage
and admission
Conservative tx with
NSAIDs
Improvement after 4–7
days?
Improvement after 7 days?
NO
NO
YES
FEVER?
Continue tx
+
Consider CT scan then
LP if no mass lesions
YES
Tx w/ PCN
Is patient hypotensive,
tachycardic, critically ill?
YES
NO
NO
Tx for sepsis → pan
culture, broad
spectrum ABX
Tailor ABX based on
organism identification
CT scan of head
Get CSF labs:
+PMNs → tx as
meningitis
+AFB or lymphocytes →
tx as TB meningitis
+India ink, high opening
pressure, low # of PMNs
→ tx as cryptococcal
meningitis
+EBV → tx as CNS
lymphoma
Check malaria,
typhoid tests
CT results:
 Lesions with mass
effect → consider toxo
or CNS lymphoma
 Multifocal areas of
demyelination →
consider PML
 Encephalopathic
changes → consider
HIV encephalopathy
Check VDRL

YES
Resume
routine
follow-up
YES

+
Consider CT,
then do LP
Treat
accordingly
If mass lesion present →
consider steroids along with
appropriate therapy
For all patients:
 Ensure all patients are
on HAART and
prophylactic medicines
180
Hypertension
Any BP measurement > 210/120
BP checks done at rest
Recheck BP
Ask about
drug/ETOH
overuse or
withdrawal
ETOH
withdrawal
Benzos
Consider admit
cocaine
Benzos
No -blockers
NONE
Check for end-organ damage:
 Fundoscopic exam
 EKG
 Renal function/UA
 Mental status ’s
 Pulmonary edema
 Chest pain
YES
 IV anti-HTN
meds to  DBP
to 100–110
over 1–2 hrs
 Avoid
nifedipine
Good hx and exam:
 Onset if known
 Sx
 Family/social hx
 Cardiac/eye exam
Age of pt
<30, >60
Age of pt
30–60
Start with same therapy but
consider a sooner workup for
2 HTN if pt is < 30 or > 60 yrs
NO
PO anti-HTN
No
blockerFor all
patients:
Lifestyle
modificatio
n
counseling

 Pt now has the dx of HTN.
smoking/E
 Treat with oral agents asTOH
output to
keep BP < 135/80 diet/exercise
 sodium
 weight
s
y 25% every 4–
6 hours
For all patients:
 Lifestyle modification
counseling
  smoking/ETOH
 diet/exercise
  sodium
  weight
3 BP measurements  140/90
Labs to consider:
 blood glucose
 UA for protein
 renal labs
 thyroid
 lipids
 EKG
Lifestyle changes:
  smoking/ETOH
 good diabetes control
  weight
 diet, exercise
Don’t start meds @ 1st visit
If BP still  after 1–2 months,
start HCTZ 12.5 mg PO OD,
then  to 25 mg PO OD
If further BP control needed,
slowly add CCB, ACEi (esp. if
+proteinuria), -blockers
If 3 or more medicines are used,
consider causes of 2 HTN:
 Hyperaldosteronism
 renal disease
 pheochromocytoma
 renal artery stenosis
 Cushing’s syndrome
Check labs, consider renal US,
renal artery duplex or CT abd/pelvis
181
Oral Lesions
Hx and Exam: duration, painful or
painless, associated sx, meds, CD4 count.
White pseudomembranous
patches on
buccal mucosa/
tongue
Ensure patient
on ARVs if
CD4< 200
YES
Painful
swallowing?
YES
NO
Systemic tx:
fluconazole 200mg
OD, can ↑ up to
800mg OD if
needed
NO
Erythematous lesions or
angular cheilitis
YES
Oral thrush:
 fluconazole 200mg x
1, then 100mg OD x
7/7
 nystatin swish/ spit
5mL PO QID x 7/7
 nystatin tablets
500,000 IU QID
Do KOH if
possible
NO
White lesions w/ folds located
on lateral edge of tongue
YES
Oral hairy leukoplakia:
no tx
YES
HSV: acyclovir 200
mg 5x/day x 7/7
YES
Herpes zoster: acyclovir
800mg 5x/ day x 7 days
YES
KS: no systemic
treatment
YES
Aphthous stomatitis: can try short course of prednisone or
tetracycline 2500 cc dissolved in water (gargle and spit)
YES
Ulcerative or necrotizing gingivitis:
 Flagyl 500 mg TID x 7/7
 Pen V 500 mg QID x 7/7
NO
Small vesicles in groups,
painful, erythematous base
NO
Vesicles in dermatomal
distribution
NO
Papules, macules, nodules
that are red, purple, black
Ensure patient is
on ARVs
NO
Oral ulcers, no vesicles,
painful
NO
Gum inflammation/
destruction w/ bleeding
182
Peripheral Neuropathy
Hx and Exam:
Onset, duration, location, uni- vs. bilateral, hx of DM/ETOH/smoking, ARV hx, sensation testing
Temporal association w/starting
meds?
DM w/ poor control?
 Reinforce
d4T/ddI
 Topical
lidocaine
 Capsaicin
cream
 Amitriptylin
e 25 mg
daily, can
 as
tolerated
glycemic control
 Start DM meds if
not yet started:
use low dose oral
meds first
INH
Pyridoxine
50 mg OD
No
improvement:
 dose to
100 mg OD
If no improvement:
 Topical lidocaine
 Capsaicin cream
 Amitriptyline
Heavy ETOH use
 Counsel to 
ETOH use
 Check B2,
folate
 Give thiamine,
Vitamin B
complex
 Advise
smoking
cessation
+ Hx of STDs or
syphilis
Improvement?
YES
Follow
patient
closely
NO
Consider :
d4T  AZT
ddI  3TC
Check VDRL:
 If +, tx w/ penicillin
No obvious precipitant
Check TSH, vitamin B12,
folate, RPR
Normal
Abnormal
Treat
accordingly
 Consider HIV neuropathy
 Start ARV if CD4 < 200
NO
Weakness present?
Consider referral for EMG,
especially if asymptomatic
 Consider CT scan, then LP
 If CMV+, consider
gangcyclovir
 Consider EMG referral
 Consider steroids
For all patients:
Daily foot care and foot checks, no barefoot walking,  ETOH/tobacco
183
Rash, Generalized (page 1)
Hx and exam:
Onset, location, sx (itching, pain), spread, fever, other systemic sx, medications, CD4 count
NO
Recently added medications?
Proceed to page 2
of rash algorithm
YES
 Stop medication
 Give 0.3 mg epinephrine
 Pt should be in
Wheezing, laryngeal
edema, tongue swelling,
nausea/vomiting, shock
YES
emergency
 No rechallenging
NO
YES
Was Septrin recently started?
NO
Were ARVs recently started?
< 30% of body affected,
pruritic, +/- low-grade
fever
Fever and systemic sx:
Cough, GI sx, arthralgias,
lymphadenopathy
Treat
symptomatically.
If severe rash, stop
Septrin and change
to Dapsone for PCP
prophylaxis.
Fever, skin
blistering, mucous
membrane
involvement
YES
 Supportive therapy with antihistamines
and topical steroids.
 Do not need to stop drug if sx are mild.
Is pt on
nevirapine?
NO
Is pt on abacavir?
YES
Do sx worsen after
each dose?
YES
SEVERE SX (blistering,
mucous membrane
involvement):
 Stop NVP
  to EFV
MILD SX:
  dose to 200
mg OD
 Follow closely
 ABC
hypersensitivity.
 Stop ABC and
do not
rechallenge.
 Stop the
offending ARV
 Tx as SJS or
TEN
 Admit for
supportive care
(treat as if it’s a
burn)
 Avoid the
offending ARV
(no rechallenge)
184
Rash, Generalized (page 2)
No new or recent medicines
Treat as seborrheic dermatitis:
 Ketoconazole cream BD +/ketoconazole shampoo 2x/week
YES
Erythematous or white scaly/flaky patches,
usually on forehead/scalp, sparing nose
NO
NO
Umbilicated papules, nonpruritic
Treat as candidiasis:
 Topical antifungals BD
 Fluconazole 100-200 mg OD OR
 Ketoconazole 200-400 mg OD
YES
Beefy red areas, moist, may be more
common in intertriginous areas
NO
Molluscum Contagiosum. No specific tx.
Fever?
Pulmonary sx?
YES
Meningeal signs?
Disseminated Cryptococcosis.
YES
NO
Macules/papules, involving
palms/soles, nonpruritic
+ India
Ink
YES
Systemic sx?
Recent hx of painless genital ulcer?
VDRL
+
PCN tx
Cryptococcal meningitis:
 Ampho B + flucytosine x
14 days then Fluconazole
400 mg OD x 10 weeks,
then 200 mg OD lifetime
NO
YES
Normal hyperpigmentation.
Pt should be
reassured.
NO
Red papules that evolve into larger
papules/nodules
YES
Consider KS
if CD4 low
+ India
Ink
 Fluconazole
400 mg OD
x 8 weeks
then 200
mg OD
Folliculitis:
 Tx initially with conservative measures.
 Can also try dicloxacillin
 Avoid Vaseline on arms and legs.
YES
Papules/pustules on arms, legs, scalp
Perform LP
NO
Bacillary angiomatosis:
 Tx with erythromycin 500 mg QID x 3
mo, or doxycycline 100 mg OD x 3 mo
YES
NO
Small pink or normal skin colored
papules, excoriations, pruritic, found
in interdigital areas, waistline, chest,
back, abdomen
NO
Papules/pustules on body, severely ill
YES
Consider disseminated miliary TB:
 Tx for extrapulmonary TB
No local tx
YES
Are large areas of the body
involved? Are lesions
crusted/hyperkeratotic?
Norwegian scabies:
YES  Isolate
 Ivermectin 200 g/kg PO x
1 + benzyl benzoate lotion
NO
Scabies:
 Permethrin cream or
ivermectin
 Tx entire family
 Wash all clothes
185
Appendix C: How to do a 24-hour dietary recall
Dietary assessment is important to assess whether the quantity and diversity of food consumed
is adequate to provide enough energy and the essential nutrients. The assessment can be done
using the form below. Use the following questions to guide you.
1. Ask the client/caregiver what they ate and/or drank the previous day. Start by asking the
foods eaten during a) breakfast b) lunch c) dinner d) Food and/or beverage eaten between
the break snack e) other (specify).
2. Include everything that they ate and drank, including foods and drinks that were not
prepared or consumed at home — include even juices, soda, milk, snacks, fruits, or other
foods. WHEN RESPONDENT STOPS, ASK: Anything else?
3. Ask for the description of food and drinks:
a. Was the food prepared at home or bought? What were the ingredients of each of the
foods?
b. Ask how the food was cooked (boiled, fried, stewed, roasted)?
c. Ask for other ingredients added to the food, either during preparation or after (e.g. salt,
sugar, spices, etc).
4. For each food item ask how much they actually ate/drank?
a. Volume: How much? (Tsp, Tbsp, cup) or
b. Weight: What was the weight of the portion eaten? (Only if applicable)
c. Number: How many did they eat?
d. Size: What size were they? [Big, large, medium, small] Use plate size to estimate
quantities or use food atlas if available
e. Shape: What shape were they? [Cubed, rounded, oval…]
5. REVIEW: to make sure all food items eaten the previous day are recorded.
The table below can be used to record the foods eaten at different times.
Dietary recall can then be used to compute the client’s food diversity. The patient should have
eaten foods in each of the different food groups: (1) cereals, tubers and breads (2) oils, butter,
ghee and fats (3) meats, fish, dairy, and beans/nuts, (4) fruits and vegetables and (5) water.
The health worker can estimate whether the client ate enough food given his/her age, body size,
activity level, and sex.
One can also find out whether the reported frequency, kind of foods, amounts, etc. reflect the
usual feeding patterns or not. If not, is it more or less?
186
24-Hour Recall Assessment Form
Name:
MEAL TIME
Age:
Sex:
ITEM EATEN (FOOD AND DRINKS)
Ref. No.:
QUANTITY
BREAKFAST
SNACKS BETWEEN
BREAKFAST AND LUNCH
LUNCH
SNACKS BETWEEN
LUNCH AND DINNER
DINNER
SNACKS BEFORE/AFTER
BEDTIME
NOTES
Nutritionist:
Signature:
Date:
From: Republic of Kenya, Ministry of Health, NASCOP. (May 2007). Nutrition and HIV/AIDS: A Tool Kit for Service Providers in
Comprehensive Care Centres.
187
Appendix D: Patient nutrition management form (adult)
Reference No.:
Date:
Name:
Visit Number: [
Age (yrs):
]
]
Sex:
Risk Factors (in last month?)
Excellent/
No problem
Good/
Not serious
Poor/Severe
Adequate Dietary practice put
in place to manage it if poor?
Y or N (or Not Quite?)
Appetite
Nausea and vomiting
Sore mouth or when eating
is painful
Changed taste of foods
Constipation and bloating
Colds, coughs
Anemia
Diarrhea
Others
++Judge whether dietary approach used is appropriate.
Do you take alcohol?
 Yes
 No
Do you smoke?
 Yes
 No
Quantity
Physical Activity:
Ability to perform basic work since last
session:
 Low
 Medium
 High
 Much Better
 Better
 Worse
Medical History: What medicines are you taking?
ARVs being taken
Any Dietary Implications
Observed the dietary implications?
(Y, N, Not Always)
1.
2.
3.
Other Medicines
1.
2.
3.
188
Anthropometric, Biochemical and Dietary Assessments
Has client been weighed at least
twice in the last 6 months?
 Yes
 No
Blood pressure
Patient knows target weight?
 Yes
 No
Glucose
Last weight (LW):
(kg)
Hours postprandial
Current weight (CW):
(kg)
Cholesterol
Height:
(m)
Triglycerides
MUA:
Current BMI:
Body fat%
Weight Change (CW-LW):
(kg)
Dietary action
Consumed at least three meals in the last 3 days AND
at least a snack in last 24 hours
Consumed 1) fruit AND 2) vegetable AND 3) foods
prepared with oils, fats; AND EITHER 4a)
meat/fish/eggs/milk? OR 4b) nuts/legumes on the day
prior to the client’s visit to the site in last 24 hours
Drunk at least 8 glasses of boiled/clean safe water in
last 24 hours
Fat Mass
Yes / No
If not, why?
 Yes  No
 Yes  No
 Yes  No
Nutritional Management Plan
Weight targets?
Recommendation on Dietary symptom management?
Recommendation on drug-food interaction?
Recommendation on food intake (energy increase, food
diversity, food accessibility)
Any micronutrients given?
Any demonstration made?
Referral made?  Yes
 Yes
Type:
 Yes
 No
Over how long (months)
 No
Any food supplements
distributed?
Why?
Which?
How much?
 No
 Yes
 No
If YES, to who?
Screened by:
Signature:
Counseled by:
Signature:
From: Republic of Kenya, Ministry of Health, NASCOP. (May 2007). Nutrition and HIV/AIDS: A Tool Kit for Service Providers in
Comprehensive Care Centres.
189
Appendix E: Nutritional assessment tool for PLWHIV
Form to Monitor Nutrition Status Over Time
Name:
Age:
Sex:
In the form below, write down when patient was weighed. Take weight without shoes and
wearing similar light clothes each time. Note any events, illnesses, or changes in eating habits
and amount of foods eaten, etc. that might have caused weight loss. Where possible also note
CD4 counts and hemoglobin (Hb).
BMI is calculated as weight (kg)/height (meters²).
Date of
visit
Height
(cm)
Weight
(kg)
Amount
weight
Increase↑ or
Decrease↓
BMI
CD4
Hb
Remarks
(specify
any
changes)
From: Republic of Rwanda, Ministry of Health. National Guidelines for Food and Nutritional Support and
Care for People Living with HIV/AIDS in Rwanda. Adapted from FAO, Living Well with AIDS, Rome:
2002.
190
Illustrative examples of national adaptations
Illustrative Examples of national level adaptation of WHO Antiretroviral therapy for HIV
infection in adults and adolescents: recommendations for a public health approach 2010
(or 2009 versions prepared after release of 2009 WHO Rapid Advice) can be found in
the following documents:

National Department of Health, South Africa (2010). Clinical Guidelines for the
Management of HIV & AIDS in Adults and Adolescents

NASCOP (2010). Revised National ART Guidelines Kenya.
191
List of tables and figures
Table 1: WHO recommendations at a glance, WHO Antiretroviral Therapy for
HIV infection in Adults and Adolescents: Recommendations for a public health
approach, 2010 revision ................................................................................................ 11
Table 2: Summary of changes, WHO Antiretroviral Therapy for HIV infection in
Adults and Adolescents: Recommendations for a public health approach, 2010
revision .......................................................................................................................... 12
Figure 1: Recommendations at a glance, AIDS Institute New York State
Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary
Care Practitioner ........................................................................................................... 22
Table 3: Criteria for ART initiation in specific populations, WHO Antiretroviral
Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision ........................................................................... 23
Table 4: WHO clinical staging of HIV disease in adults and adolescents, WHO
Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision ................................... 23
Table 5: When to start ART, WHO Antiretroviral Therapy for HIV infection in
Adults and Adolescents: Recommendations for a public health approach, 2010
revision .......................................................................................................................... 33
Table 6: What ART to start, WHO Antiretroviral Therapy for HIV infection in
Adults and Adolescents: Recommendations for a public health approach, 2010
revision .......................................................................................................................... 34
Table 7: Treatment adherence partners ....................................................................... 40
Table 8: Global technical treatment recommendations ................................................ 45
Table 9: Preferred first-line ART in treatment-naïve adults and adolescents,
WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision ................................... 46
Table 10: Dosages of recommended ARV, WHO Antiretroviral Therapy for HIV
infection in Adults and Adolescents: Recommendations for a public health
approach, 2010 revision ............................................................................................... 47
Table 11: Acceptable ARV regimens for treatment-naïve patients, Panel on
Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of
ARV agents in HIV-infected adults and adolescents. Department of Health and
Human Services (DHHS) .............................................................................................. 48
Table 12: ARV components not recommended as initial therapy, Panel on
Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of
192
ARV agents in HIV-infected adults and adolescents. Department of Health and
Human Services (DHHS) .............................................................................................. 50
Table 13: ARV regimens or components that should not be offered at any time,
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the
use of ARV agents in HIV-infected adults and adolescents. Department of Health
and Human Services (DHHS) ....................................................................................... 51
Table 14: Laboratory monitoring before, during and after initiating ART, WHO
Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision .................................... 55
Table 15: Initiation of CTX prophylaxis among adults and adolescents living with
HIV, WHO. Guidelines on Co-trimoxazole prophylaxis for HIV-related infections
among children, adolescents and adults: recommendations for a public health
approach. Geneva 2006 ................................................................................................ 61
Table 16: Summary of recommendations for discontinuing primary CTX among
adults and adolescents, WHO. Guidelines on Co-trimoxazole prophylaxis for HIVrelated infections among children, adolescents and adults: recommendations for
a public health approach. Geneva 2006 ........................................................................ 62
Table 17: CTX toxicity grading scale for adults and adolescents, WHO.
Guidelines on Co-trimoxazole prophylaxis for HIV-related infections among
children, adolescents and adults: recommendations for a public health approach.
Geneva 2006 ................................................................................................................ 63
Figure 2: Algorithm for diagnosis of TB in ambulatory HIV-positive patient,
EGPAF Phase 1 Toolkit: Understanding the Revised WHO Recommendations
and Supporting Their Adaptation into National Guidelines, 2010 .................................. 67
Figure 3: Algorithm for TB screening in adults and adolescents living with HIV in
HIV-prevalent and resource-constrained settings, WHO Guidelines for intensified
tuberculosis case finding and isoniazid preventive therapy for people living with
HIV in resource constrained settings, 2011 ................................................................... 68
Table 18: Diagnostic criteria for staging of HIV-related clinical events, WHO
Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision .................................... 71
Table 19: Measures for facility-level TB infection control, WHO policy on TB
infection control in health-care facilities, congregate settings and households,
2009 .............................................................................................................................. 79
Table 20: Grading of selected clinical and laboratory toxicities, WHO
Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision .................................... 83
Table 21: Toxicities and recommended drug substitutions, WHO Antiretroviral
Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision ........................................................................... 86
193
Table 22: ARV-related adverse events and recommendations, WHO
Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision .................................... 88
Table 23: Symptom-directed toxicity management, WHO Antiretroviral Therapy
for HIV infection in Adults and Adolescents: Recommendations for a public health
approach, 2010 revision ................................................................................................ 89
Table 24: ART switching criteria, WHO Antiretroviral Therapy for HIV infection in
Adults and Adolescents: Recommendations for a public health approach, 2010
revision .......................................................................................................................... 92
Figure 4. Targeted viral load strategy for failure and switching, WHO
Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision .................................... 93
Figure 5: Routine viral load strategy for failure and switching, WHO Antiretroviral
Therapy for HIV infection in Adults and Adolescents: Recommendations for a
public health approach, 2010 revision .......................................................................... 94
Table 25: Preferred second-line ART options, WHO Antiretroviral Therapy for
HIV infection in Adults and Adolescents: Recommendations for a public health
approach, 2010 revision ................................................................................................ 99
Table 26: ART switching criteria, WHO Antiretroviral Therapy for HIV infection in
Adults and Adolescents: Recommendations for a public health approach, 2010
revision ........................................................................................................................ 100
Table 27: Monitoring ART in those at higher risk of adverse events, WHO
Antiretroviral Therapy for HIV infection in Adults and Adolescents:
Recommendations for a public health approach, 2010 revision .................................. 100
Figure 6: d4T toxicity assessment, Republic of Kenya, Ministry of Health,
NASCOP ..................................................................................................................... 101
Table 28: Toxicities of third-line ARVs, WHO Antiretroviral Therapy for HIV
infection in Adults and Adolescents: Recommendations for a public health
approach, 2010 revision .............................................................................................. 105
Table 29: STD treatment guidelines table for adults and adolescents, California
STD/HIV Prevention Training Center California Department of Public Health STD
Control Branch, 2011 ................................................................................................. 115
Table 30: ART regimens recommended for women with prior exposure to
PMTCT regimen, WHO Antiretroviral Therapy for HIV infection in Adults and
Adolescents: Recommendations for a public health approach, 2010 revision ............. 126
Table 31: ART options recommended for HIV-infected pregnant women who are
eligible for treatment, WHO Antiretroviral Drugs for Treating Pregnant Women
and Preventing HIV Infection in Infants, 2010 version. ................................................ 127
Table 32: Modern medications and recommended food intakes and side effects
of ARVs, Tanzania National Guidelines ...................................................................... 137
194
Table 33: Body mass index (BMI): Vertex42, Spreadsheet Templates,
Calculators, and Calendars, The Guide to Excel in Everything. Available at:
http://www.vertex42.com/ExcelTemplates/Images/body-mass-index-chart.gif ............ 139
Table 34: Common indications for domestic violence mental health care for
people with HIV, AIDS Institute New York State Department of Health. HIV
Infection: HIV Clinical Guidelines for the Primary Care Practitioner ............................ 148
Table 35: Neuropsychiatric side effects of selected medications used in HIV
disease, AIDS Institute New York State Department of Health. HIV Infection: HIV
Clinical Guidelines for the Primary Care Practitioner................................................... 152
Table 36. Interactions between HIV-related medications and psychotropic
medications: indications and contraindications, AIDS Institute New York State
Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary
Care Practitioner ......................................................................................................... 153
Table 37: Drugs used to target symptoms of AIDS dementia complex, AIDS
Institute New York State Department of Health. HIV Infection: HIV Clinical
Guidelines for the Primary Care Practitioner ............................................................... 159
195
References and resources
SOP 1: Registration and enrollment
Centers for Disease Control and Prevention National Center for STD HIV Viral Hepatitis and TB
Prevention, Global AIDS Program (November 2007). Couples HIV Counseling and Testing
Intervention and Curriculum
Global Network of People Living with HIV/AIDS (GNP+) (September 2009). Positive Health,
Dignity and Prevention Technical Consultation Report 27-28 April 2009, Hammamet, Tunisia
Ministry of Health and Social Welfare, Tanzania (March 2009). Standard Operating Procedures
for HIV Testing and Counseling (HTC) Services Tanzania
Uganda Ministry of Health, the Republic of Uganda (2005). HIV Counseling and Testing: A
National Counselor Training Manual
WHO HIV Testing and Counselling (TC) toolkit
http://www.who.int/hiv/topics/vct/toolkit/en/index.html
SOP 2: Initial assessment visit to determine eligibility
SOP 3: Clinical Visit — clients not eligible for ART
SOP 4: Clinical Visit — clients eligible for ART
SOP 6: ART regimen selection
SOP 8: Provide CTX prophylaxis
SOP 9: Provide INH preventive therapy
SOP 10: Management of common symptoms and complications of HIV
SOP 11: Management of common HIV-associated coinfections
SOP 12: Recognition of adverse events and ART toxicity
SOP 13: Recognition of treatment failure and when to switch ART regimens
SOP 15: Switching to third-line ART regimens
SOP 19: ART and HIV-related treatment for WRA
Bartlett, John, J. Gallant and Paul Pham (2009-2010). Medical Management of HIV Infection.
Johns Hopkins School of Medicine Baltimore
Department of Health and Human Services (DHHS), Panel on Antiretroviral Guidelines for
adults and Adolescents (January 10, 2011). Guidelines for the use of ARV agents in HIVinfected adults and adolescents; 1-166
Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) (May 2010). Phase 1 Toolkit:
Understanding the Revised WHO Recommendations and Supporting Their Adaptation into
National Guidelines. Washington, DC.
Family Health International Collaborative TB/HIV Services (October 2009). Standard Operating
Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites
196
Guide to Primary Care of People with HIV/AIDS
http://www.hab.hrsa.gov/tools/primarycareguide/index.htm
HIV Medicine Association of the Infectious Diseases Society of America (2009). Primary Care
Guidelines for the Management of Persons Infected with Human Immunodeficiency Virus:
2009 Update. Clinical Infectious Diseases 2009; 49:651–681
World Health Organization (2010). Antiretroviral therapy for HIV infection in adults and
adolescents: recommendations for a public health approach
World Health Organization, Department of HIV/AIDS; Stop TB Department (2011). Guidelines
for intensified tuberculosis case finding and isoniazid preventive therapy for people living
with HIV in resource-constrained settings
World Health Organization, Department of HIV/AIDS (2010). Priority interventions: HIV/AIDS
prevention, treatment and care in the health sector
SOP 5: Treatment readiness and adherence counseling
Bannet Ndyanabangi (February 2006). Adherence to ART PowerPoint presentation.
Management Sciences for Health (MSH): Nairobi
Horizons/Population Council International Centre for Reproductive Health (2004). Adherence to
antiretroviral therapy in adults: A Guide for Trainers. Coast Province General Hospital,
Mombasa Ministry of Health, Kenya.
Kobin AB, Sheth N.U., (2011). Levels of Adherence Required for Virologic Suppression among
Newer Antiretroviral Medications. The Annals of Pharmacotherapy 2011; 45(3): 372-379.
Mayer Kenneth H. et al. (2011). Pharmacy Adherence Measures to Assess Adherence to
Antiretroviral Therapy: Review of the Literature and Implications for Treatment Monitoring
Clin Infect Dis. (2011) 52(4): 493-506 first published online January 18, 2011
Steel G., Nwokike J., Joshi M. (August 2007). Development of a Multi-Method Tool to Measure
ART Adherence in Resource-Constrained Settings: The South Africa Experience Rational
Pharmaceutical Management Plus Program. Management Sciences for Health: Arlington,
VA (Patient adherence record form p. 31-34 and Instructions for completing patient
adherence record p. 35-43)
World Health Organization (2009). Pharmacological treatment of mental disorders in primary
health care
World Health Organization (2008). Mental Health Gap Action Programme: scaling up care for
mental, neurological and substance use disorders
World Health Organization (2007). Chronic HIV care with ART and prevention: Integrated
Management of Adolescent and Adult Illness, Integrated Management of Childhood Illness
interim guidelines for health workers at health centre or district hospital outpatient clinic.
World Health Organization Mental Health homepage http://www.who.int/mental_health/en
197
SOP 8: Provide CTX prophylaxis
The following reference is in addition to those listed for SOPs 2, 3 and 4:
World Health Organization, Department of HIV/AIDS (2006). Guidelines on co-trimoxazole
prophylaxis for HIV-related infections among children, adolescents and adults:
recommendations for a public health approach.
SOP 14: Switching to second-line ART regimens
Bartlett, John, J. Gallant and Paul Pham (2009-2010). Medical Management of HIV Infection.
Johns Hopkins School of Medicine Baltimore
Department of Health and Human Services (DHHS), Panel on Antiretroviral Guidelines for
adults and Adolescents (January 10, 2011). Guidelines for the use of ARV agents in HIVinfected adults and adolescents; 1-166
HIV Medicine Association of the Infectious Diseases Society of America (2009). Primary Care
Guidelines for the Management of Persons Infected with Human Immunodeficiency Virus:
2009 Update. Clinical Infectious Diseases 2009; 49:651–681
Renaud-Théry, F. (15 February 2011). Annual 2010 Survey on ARV Use and Trends in
Implementation of WHO 2010 ART Recommendations PPT (presented at WHO & UNAIDS
Annual Consultation With Pharmaceutical Companies — Global Forecasts of Antiretroviral
Demand 2011-2012, Geneva, 9&10 December 2010)
World Health Organization (2010). Antiretroviral therapy for HIV infection in adults and
adolescents: recommendations for a public health approach
World Health Organization, Department of HIV/AIDS (2010). Priority interventions: HIV/AIDS
prevention, treatment and care in the health sector
SOP 16: Contraception
SOP 17: STI screening for adults and adolescents
SOP 18: Cervical screening
SOP 20: Counseling and support for adults and adolescents living with HIV
SOP 21: HIV prevention for people living with HIV
Anderson, Jean (2005). A guide to the Clinical Care of Women with HIV. Health Resources and
Services Administration (HRSA) US Department of Health and Human Services
http://www.hab.hrsa.gov/
Centers for Disease Control and Prevention (2010). Sexually Transmitted Diseases Treatment
Guidelines, MMWR 2010; 59
Ministry of Health Botswana (2008) STI Treatment Algorithms Botswana National HIV/AIDS
Treatment guidelines
198
World Health Organization (2007). Training modules for the syndromic management of sexually
transmitted infections. -- 2nd ed., “Module 3, History-taking and Examination”. Available at:
http://www.who.int/reproductivehealth/publications/rtis/9789241593407/en/index.html
World Health Organization Geneva (2006). Comprehensive cervical cancer control: a guide to
essential practice
World Health Organization (2003). Guidelines for the management of sexually transmitted
infections.
SOP 22: Nutritional assessment
SOP 23: Determine level of nutritional support needed
SOP 24: Develop nutrition care plan
Department of Health South Africa (2001). South African National Guidelines on Nutrition for
People Living with TB, HIV/AIDS and other Chronic Debilitating Conditions
East, Central and Southern African Health Community Secretariat (ECSA-HC), Food and
Nutrition Technical Assistance (FANTA) AED, USAID/East Africa (2008). Nutrition Care for
People Living with HIV and AIDS: Training Manual for Community and Home-Based Care
Providers Facilitators Guide and Participant Handouts Uganda.
East, Central and Southern African Health Community Secretariat (ECSA-HC), Food and
Nutrition Technical Assistance (FANTA) AED, USAID/East Africa (August 2008). Nutrition
and HIV/AIDS: A Training Manual for Nurses and Midwives.
Ministry of Health Kenya (May 2007). Nutrition and HIV/AIDS: A Toolkit for Providers in
Comprehensive Care Centers
Ministry of Health Republic of Rwanda (2006). National Guidelines for Food and Nutritional
Support and Care for People Living with HIV/AIDS in Rwanda
USAID (February 2007). Recommendation for the Nutrient Requirements for People Living with
HIV/AIDS
World Health Organization (2003). Technical Consultation on Nutrient Requirements for People
Living with HIV/AIDS
World Health Organization (2003). Nutrient requirements for people living with HIV/AIDS: report
of a technical consultation, Geneva, 13–15 May 2003
199
SOP 25: Conduct mental health assessment
SOP 26: Conduct mental status examinations
SOP 27: Develop mental health care plan
AIDS Institute New York State Department of Health. Mental Health Care for People With HIV
Infection: HIV Clinical Guidelines for the Primary Care Practitioner
Africa Mental Health Foundation website: http://www.africamentalhealthfoundation.org/
American Psychiatric Association Steering Committee on Practice Guidelines. Practice
Guideline for the Treatment of Patients With HIV/AIDS
World Health Organization (2008). HIV/AIDS and Mental Health. Report by the Secretariat
Executive Board 124th Session
World Health Organization (2005). Mental health & HIV/AIDS therapy series
World Health Organization in collaboration with the Victorian Health Promotion Foundation and
the University of Melbourne (2005). Promoting mental health: concepts, emerging evidence,
practice:
200