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Authors: Serge Agbo, MD, MPH and Sabrina Eagan, MSN, MPH 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: Clement Adje, Judith Kose, Selina Mathias, Martha Mukaminega, Appolinaire Tiam, Thabile Vezi Moses Walakira, Damilola Walker Lois Eldred and Celine Gounder from CREATE-Johns Hopkins University. 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 Anne Reilly 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.................................................................................................................... 6 Introduction ............................................................................................................................................... 8 Part 1: Organization of TB services in HIV care and treatment settings .. 12 SOP 1: TB-HIV care and treatment operational overview ................................................................... 15 SOP 2: Transferring or referring patients.............................................................................................. 20 SOP 3: Record keeping ........................................................................................................................ 22 SOP 4: Data management and quality improvement .......................................................................... 24 Part 2: Delivery of TB-HIV services in health facilities............................... 26 SOP 5: TB infection control ................................................................................................................... 32 SOP 6: TB screening in HIV-infected individuals ................................................................................. 37 SOP 7: TB diagnosis in HIV-infected individuals................................................................................... 42 SOP 8: TB treatment .............................................................................................................................. 51 SOP 9: CTX prophylaxis to HIV positive patient with active TB disease ............................................ 57 SOP 10: TB-ART co-treatment regimens.............................................................................................. 60 SOP 11: TB-HIV Treatment monitoring................................................................................................. 67 SOP 12: Isoniazid Preventive Therapy.................................................................................................. 73 SOP 13: Promoting and monitoring treatment adherence, directly observed therapy (DOT)............. 77 SOP 14: Monitoring and managing TB treatment and ART ................................................................. 87 SOP 15: Determining TB treatment outcome ....................................................................................... 94 SOP 16: Diagnosis and treatment of resistant TB ..............................................................................100 SOP 17: Treatment supporter training and responsibilities ................................................................107 SOP 18: TB and HIV co-infection patient education ...........................................................................113 References ................................................................................................ 118 List of tables and figures ........................................................................... 121 Appendices ............................................................................................... 124 Appendix 1: TB Treatment Card ..........................................................................................................125 Appendix 2: HIV Care / ART card........................................................................................................126 Appendix 3: Sample TB-HIV referral/transfer form .............................................................................127 Appendix 4: Sample report on TB-HIV notifications............................................................................128 Appendix 5: Sample infection control (IC) assessment tool ...............................................................129 Appendix 6: Visual representation of sputum collection procedure....................................................130 Page 4 Appendix 7: TB screening tool for children (ICAP)..............................................................................131 Appendix 8: Sample TB screening tool for adults (1)..........................................................................132 Appendix 9: Sample TB screening tool for adults (2)..........................................................................133 Appendix 10: Sample AFB request form .............................................................................................134 Page 5 Acronyms and abbreviations AFB AIDS ALT ART ARV AZT BCG BMU Acid‐fast bacilli Acquired immune deficiency syndrome Alanine amino transferase Antiretroviral therapy Antiretroviral drugs Zidovudine (also known as ZDV) Bacillus Calmette-Guérin Basic management unit BMI Body mass index CBO CD4 CDC COPD CTC CTX CXR d4T Community‐based organization Cluster of differentiation 4 US Centers for Disease Control and Prevention Chronic obstructive pulmonary disease Care and treatment clinic Cotrimoxazole Chest x-ray Stavudine DOT DR DR-TB DST EFV ETB FBC FDC FHI Directly observed therapy Drug resistant Drug resistant TB Drug susceptibility testing Efavirenz Extrapulmonary tuberculosis Full blood count Fixed dose combination Family Health International HIV IC IDU IDV IMAI INH IRIS 3TC Human immunodeficiency virus Infection control Injection drug user Indinavir Integrated management of adult illness Isoniazid Immune reconstruction inflammatory sydrome Lamivudine Page 6 LPV MDR-TB NNRTI NRTI NTP NVP PI PLHIV PMTCT PTB Lopinavir RFT RIF SOP SSM STI TB TBLN TDF TLC Renal function test Rifampicin Standard operating procedure Sputum smear microscopy Sexually transmitted infection Tuberculosis Tuberculosis lymphadenitis Tenofovir Total lymphocyte count TST VCT WHO XDR-TB Tuberculin skin test Voluntary counseling and testing World Health Organization Extremely drug resistant tuberculosis Multi‐drug resistant tuberculosis Non‐nucleoside reverse transcriptase inhibitor Nucleoside reverse transcriptase inhibitor National tuberculosis program Nevirapine Protease inhibitor People living with HIV Preventing mother‐to‐child transmission Pulmonary tuberculosis Page 7 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 integrating TB activities into HIV service delivery points in tertiary, secondary and primary (community-based) level of care. This template is intended to be used along with the EGPAF toolkit, the WHO 2010 recommendations and other resources to help each country team develop appropriate local materials. What is the purpose of these templates? SOPs provide a comprehensive framework of operational guidelines to assist in the translation of recommended guidelines and 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. Country-level TB and HIV services are provided in a wide range of settings with varying levels of human, material, and financial resources. These SOPs were developed to be adapted and utilized at national, regional and local levels. 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 TB and HIV service delivery even when local conditions and resources require referral and use of several care sources. SOPs are useful to: Facilitate comprehension of technical information related to TB-HIV care and treatment and maintain consistency in its application to daily practice. Increase health team’s capacity to deliver integrated TB and HIV services and care. Assist health team to deliver integrated TB-HIV services that comply with national guidelines, policies and protocols. Provide a facility-specific record of standards of service delivery. 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 health worker mistakes and omissions that may harm patients. SOPs can also: Page 8 Support staff to conduct 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. Promote “family-centered care” age-specific care approach. 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 TB-HIV SOPs were prepared by a team of EGPAF, JSI and JHU technical staff in the US. The final version was prepared following additional review of the draft for completeness and technical accuracy by staff in the US and country offices in Africa and where the Foundation is working. The SOPs were developed following extensive review of many excellent global documents, particularly the Family Health International’s SOPs for the Implementation of TB Activities at HIV/AIDS Service Delivery Sites released in October 2009. This document was updated with the World Health Organization (WHO) guidelines and policies on collaborative TB-HIV activities released during 2009–2010. The clinical sections were adapted primarily from the international guidelines for TB and HIV comanagement developed by WHO as well as other key clinical documents noted throughout the text and cited in the references. Procedures describing the organizational functioning of TB and HIV services were adapted from Family Health International SOPs written by Leine Stuart, PhD, MSN, ACRN. A complete list of the references reviewed to inform the development of these SOPs is provided. 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 recent (2010-2011) 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 TB-HIV interventions. Page 9 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 TB-HIV service delivery even when the continuum of care is provided by multiple care sources. Page 10 What is the audience for the TB-HIV SOP template? Audience for the TB-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 (QI officer, M&E officers…) These SOPs are intended for TB and HIV service points that refer clients to higher level HIV Care and Treatment Clinics (CTCs) that provide more extensive tertiary HIV 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 and national TB treatment guidelines for second and third line treatment regimens when required as well as the management of M(X)DR TB in specialized settings. What are the objectives of the TB-HIV SOP template? This set of SOPs on TB-HIV addresses both HIV service delivery and treatment objectives. Service delivery objectives include the following global health priorities: Provide a comprehensive continuum of TB-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 TB-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 TB and HIV diagnosis, assessment of antiretroviral therapy (ART) eligibility and treatment initiation for co-infected TB-HIV patients. Prevent progression of TB and HIV disease and avert TB and AIDS-related deaths. 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. Page 11 Part 1: Organization of TB services in HIV care and treatment settings Background Tuberculosis (TB) is an infectious disease caused by the bacillus Mycobacterium tuberculosis. It typically affects the lungs (pulmonary TB) but can affect other sites as well (extrapulmonary TB). The disease is spread in the air when people who are sick with pulmonary TB expel bacteria, for example by coughing. In general, a relatively small proportion of people infected with Mycobacterium tuberculosis will go on to develop TB disease; however, the probability of developing TB is much higher among people infected with the human immunodeficiency virus (HIV). TB is also more common among men than women, and affects mostly adults in the economically productive age groups; around 2/3rds of cases are estimated to occur among people aged 15–59 years. According to the WHO 2011 global TB report, in 2010, there were approximately 8.8 million new cases of TB, 1.1 million deaths from TB among HIV-negative people and an additional 0.35 million deaths from HIV-associated TB. Important new findings at the global level include the following: The absolute number of TB cases has been falling since 2006. The number of new TB cases (incidence rates) has been falling since 2002. In 2009 there were almost 10 million children who were orphans as a result of parental deaths caused by TB. Definitions Basic HIV management unit (BMU): a service delivery site where HIV care and treatment is provided, a BMU can also be referred to as a CTC or HIV clinic. Depending on the setting, the CTC is typically linked to other services within or outside of the facility including TB services (TB clinic), laboratory and pharmacy for the delivery of comprehensive HIV services. The BMU provides the following services directly or by referral (as defined by the national TB and HIV/AIDS program and policy guidelines): Educate and counsel on HIV, TB, disease progression of both TB and HIV, and how TB and HIV are interrelated; Screen and test for TB in HIV-infected individuals; Orient clients on the TB and HIV co-treatment program; Provide prophylaxis and clinical management for opportunistic infections and other HIV-related co-morbidities, including TB according to national guidelines; Page 12 Provide routine clinical care; Manage pain and other distressing symptoms; Monitor patients on anti-TB medication, INH, or TB-ART; and provide adherence support, education and counseling; Record and report TB and other opportunistic infections according to national TB and HIV program guidelines and the locally established system; Provide referrals to other complementary services. Core services of the BMU including the following (at a minimum): Triage and patient registration, which can be conducted by 1 staff member, depending on staffing and patient volume; Clinical consultation, which is provided by trained clinical staff and executed as recommended by national policy guidelines; Medical record keeping, including use of standardized registers and forms required by the national TB program (NTP) and HIV program; Referrals and linkages both within a health facility, and outside to other services such as radiology or home-based care; Quality assurance as per national Quality assurance and improvement guidelines; Pharmacy services (provided directly or by referral) to dispense drugs such as anti-TB medications, ART, opportunistic infection prophylaxis (e.g., CTX), and other HIV-related medications and palliation; Laboratory services (provided directly or by referral). All services at the BMU are guided by a TB infection control implementation plan, which includes 4 levels of control: managerial, administrative, environmental, and respiratory. Referral: The process of sending a patient to receive care or start treatment at another site or facility. Transfer: The process of moving a TB patient registered in one site’s TB register to continue treatment in another area on a different TB register. A transfer of care occurs when the referring clinician transfers the responsibility for the patient’s complete care of a particular condition to a receiving clinician. Monitoring and evaluation: monitoring and evaluation includes tracking data on an individual patient basis in the medical chart at both the site and facility levels; collecting data for district/provincial and country-level reports; clinical monitoring and mentoring to improve patient care, enhance health worker education and evaluate quality of care and service coverage. Policy WHO’s overall goal for the Stop TB Strategy is to dramatically reduce the global burden Page 13 of TB by 2015. The objectives to support achieving this goal are: Achieve universal access to high-quality care for all people with TB. Reduce the human suffering and socioeconomic burden associated with TB. Protect vulnerable populations from TB, HIV and drug-resistant TB. Support development of new tools and enable their timely and effective use. Protect and promote human rights in TB prevention, care and control. Many countries have set national policy that will support them to achieve the WHO goal and objectives. Global and national policy tend to include the following components: Pursue high-quality DOTS expansion and enhancement. Address TB-HIV, MDR-TB, and the needs of poor and vulnerable populations. Contribute to health system strengthening based on primary health care. Engage all health workers. Empower people with TB, and communities through partnership. Enable and promote research. Responsibility at health facility A single individual should be assigned at each health facility to lead the establishment and supervision of TB-HIV services. This individual would also be responsible for ensuring that quality assurance and improvement measures related to TB-HIV services are conducted according to national guidelines. TB-HIV care, treatment and support should be conducted only by health workers who have received training. These health workers should be provided with regular on-site clinical mentoring to ensure the continued quality of these services. Members of the comprehensive TB-HIV care team will vary according to level of care (facility, primary healthcare site, or community-based care site) and resources available to the site or facility, by site-specific guidelines, and by national guidelines. Page 14 SOP 1: TB-HIV care and treatment operational overview Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To provide an overview of the recommended sequence of care to ensure that patients with HIV and TB receive quality care and treatment in an environment that is safe for both patients and health workers. Responsibility Triage nurse, registration and intake staff Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Pharmacist Nutritionist Laboratory technician Adherence counselors and other treatment supporters Home-based care workers or volunteers Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. TB treatment referral/transfer form (Appendix 3), any other forms required by site protocol or national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale 4. Cotrimoxazole (CTX), ARV and TB medications 5. Laboratory test referral request form if required Procedure For all HIV-infected individuals the following sequence of care is recommended to Page 15 ensure the patient safety, quality care and treatment whether by direct care provision or coordinated referral. Triage at every baseline and follow-up visit which Includes: Registering the patient; Taking the patient’s history; Taking the patient’s vital signs; Fast-tracking acute cases and TB suspects (referred patients or coughers); Documenting findings in the medical chart; Prioritizing patients in order of arrival/appointment time as well as clinical status. Conduct general assessment (nurse, physician and/or clinical officer) which includes: Vital signs; Clinical review of signs and symptoms; Medication review (including prophylaxis); Adherence; Medication side effects; Complications; Clinical staging as per national guideline. Screen for TB in all patients at every visit (see Table 1, below): Specifically monitor TB-related symptoms and treatment side effects (if patient is already on treatment); Repeat clinical staging if new signs of clinical stage 4 disease occur and if the patient is losing weight. Provide education and support. The entire clinical staff at every visit or patient interaction will provide ongoing support and encouragement to: Participate in treatment; Discuss disease disclosure issues; Explain treatment and follow-up care; Support chronic HIV care needs; assess and support adherence to care, prophylaxis, and ART; Provide prevention with positives messages and education. Provide family-centered care (nurse, physician and/or clinical officer). See Table 2, below. Assess family status: Ask about the health of other household members; Page 16 Assess and treat for TB household friends and family (infants, children, and adults) Assess the HIV status of children in the patient’s household; Assess pregnancy status of patients and household members; Discuss family planning. Provide opportunistic infection prophylaxis: CTX (SOP 9); INH preventive therapy (SOP 12); Fluconazole prophylaxis (if indicated, e.g., following cryptococcal meningitis acute infection). Provide ART: Assess eligibility according to national guidelines (see companion SOP document entitled: “Integrated, family-centered care and treatment for HIV positive adults in low-resource settings: A template for developing SOPs”); Assess for other opportunistic infections that may need treatment prior to ART initiation; Assess mental health status, including drug and alcohol use; Assess substance use status; If on ART, monitor for signs/symptoms of IRIS, other opportunistic infections and medication side effects. Manage chronic problems: Clinic staff will check for persistent diarrhea, fever, weight loss, injecting drug use, and drug substitution therapy and also attend to palliative care needs. Provide prevention for positives education and counseling: Prevention of HIV transmission: Safer sex, condoms. Disclosure support. Harm reduction plans for substance users, IDUs and others at risk. Household and caregiver precautions. Reproductive health options, family planning, PMTCT; Positive living, such as nutrition support and exercise, having a positive outlook toward living and life, keeping the soul and spirit healthy. Provide referrals, as needed. Schedule routine follow-up: Schedule earlier appointment if required for follow-up of problems identified during Page 17 the visit; Record appointment in follow-up register. Document: Record all findings, prescribed medications and discussions in TB Treatment Card, HIV Care/ART Card, and medical record; Complete all relevant registers as per national guidelines; Complete paperwork for laboratory tests or other referrals, if applicable. Table 1: TB assessment Step Symptom screen for TB at every clinic visit or acute care appointment. Categorize patient as: TB suspect; Having TB disease; TB exposed; Having latent TB. For TB disease: Determine disease site, TB type, TB treatment category, TB-ART co-treatment plan, family status and HIV status of partner(s) and children; Decide TB or TB-ART treatment plan; Prepare TB treatment card, update HIV care card and medical record; Educate patient and family on TB and HIV; Prescribe and give: CTX to the patient; INH to patient’s household contacts including children <5; BCG to patient’s contacts <2 years. Prepare for and support treatment plan adherence: Prepare for self-management; Determine treatment supporter and DOT plan. Support patient throughout entire TB treatment, including treatment interruptions. DOT; Page 18 Manage side-effects; Continue TB-HIV education. Monitor TB and ART treatment. Determine TB treatment outcome. Adapted from: WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI). Table 2: Providing family-centered care Family-centered care includes: Information and education about the family-centered care approach during initial registration. Weekly clinic team meetings to: Discuss the health status and needs of treated family members; Develop strategies to care for and support the family. Regular record keeping: a designated team member (e.g., case manager, nurse) documents care and support interventions in the medical records of both pediatric and adult family members treated in the clinic. TB intensified case-finding. Page 19 SOP 2: Transferring or referring patients Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To determine the need for and manage the process of referral or transfer of patients, 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 the BMU. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Community health workers, peer workers, volunteers or another cadre of non-clinical staff Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. TB treatment referral/transfer form (Appendix 3), any other forms required by site protocol or national guidelines Procedure At each monthly clinic visit, assess patient for care and support needs. Needs may be physical, emotional or spiritual; they may be identified by clinical or non-clinical staff: A patient requires a referral if he or she has a care need that cannot be met at the BMU, for example, he or she requires further diagnostic work-up, or has emergent, or acute care or support needs beyond the scope of the site (see “Definitions” on page 14); A patient requires a transfer if he or she requires chronic care (e.g., treating MDR TB) beyond the scope of the site, or if the patient reports that they are moving out of the catchment area (see “Definitions” on page 14); Referrals and transfer may be to an internal or external department or communitybased agency. Regardless of where a patient is referred, the process is similar. Develop a referral/transfer plan that defines the patient’s needs and the steps to meet those needs. Discuss the referral or transfer plan with the patient. Update the plan at each visit according to the patient’s needs. Page 20 Make the referral by: Escorting the patient to the referral site; Providing the patient with the name, address, phone number, name of contact person, and hours of operation of the referral site; or Contacting the referral site yourself by phone, e-mail or text and making an appointment for the patient; Once the appointment has been made, the referral site should coordinate the delivery of services to meet the patient’s needs. Provide enough medications if this is a transfer of care and treatment. Where available, utilize community health workers, peer workers, volunteers or another cadre of non-clinical staff to assist patients with referral arrangements and to provide education and support. After the date/time of the patient’s appointment at the referral/transfer agency, track the referral by contacting the referral/transfer site to check if the patient attended as expected (i.e., arrived as agreed for their appointment). Track the referral by phone, facility visit, return slips, or return escort confirmation. Agree with the referral agency a communication plan so that the BMU is kept abreast of the referral agency’s key findings and outcomes. Ensure patient confidentiality is maintained during a referral/transfer; always protect the confidentiality of patient records. 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: Record referral in TB Treatment Card, HIV Care/ART Card, Adult Follow-up Visit Form (or other designated form per facility standard), and medical record. Medical record should also include documentation on the need underlying the referral; Complete all relevant registers as per national guidelines; Include in the medical record the outcome of the referral including any feedback or documentation received from the referral site (Appendix 3). Page 21 SOP 3: Record keeping Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To support the timely and correct completion of all TB-HIV patient records, including medical records and forms. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Registration clerk Any other health worker providing patient services (e.g. pharmacist, nutritionist, laboratory technician, counselor, adherence counselors and other treatment supporters, and home-based care workers or volunteers) Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. TB treatment referral/transfer form (Appendix 3), any other forms required by site protocol or national guidelines Procedure Create a medical record for each patient seen at the site or facility. For patients with a pre‐existing record at the site/facility, integrate the old file into the new one. This record will be stored at the facility. Maintain forms required by national or agency policy in the patient’s medical record, examples of forms that may be required include the following (where available, always use standard facility forms): Triage Nurse Assessment Form. Clinical Care: Initial Adult/Pediatric Assessment Form. TB Treatment Card (Appendix 1). HIV Care/ART Card (Appendix 2). Clinical Care/Antiretroviral Therapy: Adult Follow‐Up Form. Pre‐Start Counseling Form. Page 22 Adherence Monitoring Form. Laboratory Investigation Result Forms. All referral forms (Appendix 3). Always document findings and services provided immediately — during the actual patient visit. Documentation in the medical record and on standardized forms should be completed during or immediately after registration, the provision of clinical care, prescribing, counseling, when referrals are made, and once the next appointments is set. Complete all relevant registers as per national guidelines: TB Register; Laboratory Register. Submit patient’s medical record to BMU staff responsible for registration and records, to: Facilitate the patient’s attendance at the TB-HIV program (make appointments and follow up on missed appointments); Ensure that the patient’s medical record is available for each visit and that the appropriate forms are included in the file; Review the patient’s medical record, including all relevant forms, after each patient visit to assure their completion. The forms should be returned to the appropriate health worker for completion if data is missing. Page 23 SOP 4: Data management and quality improvement Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To ensure the accurate and timely collection of data for monitoring and evaluation of patient care as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Data clerk Any other health worker providing patient services (e.g. pharmacist, nutritionist, laboratory technician, counselor, adherence counselors and other treatment supporters, and home-based care workers or volunteers) Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. National reporting forms Procedure Ensure the collection of core indicators for monitoring and evaluation TB-HIV activities in accordance with the ministry of health's monitoring and evaluation plan (see Table 3, below, for examples of indicators and Appendix 4 for a sample quarterly reporting form and report on TB-HIV notifications): On a monthly basis, collect and report data on defined indicators (data clerk); On a quarterly basis, organize the quarterly report (data clerk); Convene periodic (monthly or quarterly) meetings with relevant staff to discuss deficiencies identified by the reports (program manager). Meeting agenda would include discussion of changes to clinic practice to improve patient care and site function. Evaluate patient satisfaction: Develop or modify a Patient Satisfaction Survey; the survey should include space to provide feedback about the care received, including suggestions for improvement and additional concerns; Page 24 Ensure all patients receive a copy of the survey; surveys can, for example, be distributed at check-in or upon visit completion; Appoint a designated site staff member, such as the registration clerk or data manager, to collect, tally, and analyze the survey data on a regular basis; Use the data and comments to improve or change site practice as needed, as well as to commend staff if feedback is positive; Report or present to patients in a poster or newsletter, ways in which their feedback was used by the site. Table 3: Examples of process indicators Process indicators for TB-HIV activity monitoring Percent of HIV patients screened for TB at their last visit. Percent of ART patients screened for TB at their last visit. Percent of HIV patients who are TB suspects at enrollment that are appropriately evaluated using national guidelines. Percent of HIV patients who are TB suspects at the last visit in HIV care that are appropriately evaluated using national guidelines. Percent of ART patients who are TB suspects at the last visit in ART care that are appropriately evaluated using national guidelines. Percent of HIV patients diagnosed with active TB at enrolment (started) on CTX. Adapted from: ICAP (November 2010). TB-HIV Standards of Care, Standard Operating Procedures for assessing TB-HIV SOCs. Page 25 Part 2: Delivery of TB-HIV services in health facilities Background Infection control (SOP 5) HIV-infected health workers are at increased risk of TB infection and active disease because of frequent exposure to TB suspects and undiagnosed individuals with TB disease in the workplace. Any pulmonary TB patient during the first 2 weeks of treatment is considered infectious. A TB patient is considered non-infectious after: Having 2–3 consecutive negative sputum smears on 2 different days while on TB treatment; Completing at least 2 weeks of DOTS with appropriate anti-TB treatment; Completing a diagnostic evaluation at the end of full TB treatment course. TB screening (SOP 6) As TB is the most frequent opportunistic infection in HIV-infected persons, routine and symptom-based TB screening and testing is particularly important. WHO recommends detecting possible TB cases as early as possible — typically using a simple questionnaire developed by the NTP. TB screening does not mean making a TB diagnosis, but it is the first step towards making a diagnosis. People suspected of having TB should receive a thorough diagnostic evaluation, with timely results, and begin appropriate evaluation treatment, either to cure active TB or to prevent it. Regular TB screening can lead to early detection of TB and screening is the gateway to INH preventive treatment. TB diagnosis (SOP 7) Evaluate TB suspects in an outpatient setting whenever possible. Diagnosing TB in HIV-infected children is difficult. Recognizing signs, symptoms and identifying exposure to active TB cases often prove more definitive than sputum sample, tuberculin skin test (TST), and CXR results. Diagnostic tests include the following: Sputum smear microscopy (SSM): Two methods are available for the direct Page 26 examination of sputum: conventional staining with carbol-fuschin [Ziehl–Neelsen (ZN)] or Kinyoun stain using light microscopy and auramine-based stains (auramine O or auramine–rhodamine) based on fluorescent microscopy. Both methods rely on the retention of stain following the application of acid. SSM is the most commonly available laboratory test for TB diagnosis in resource-limited settings. Mycobacterial culture: Traditional solid-phase sputum culture techniques such as Löwenstein–Jensen culture remain the gold standard diagnostic test for TB in most resource-limited countries. For most systems, culture becomes positive within 3–4 weeks, although those from smear-positive sputum are detectable earlier, within approximately 14 days. Although time to diagnosis may be shortened using automated liquid systems, most studies highlight the incremental benefit of using a combination of liquid and solid-phase culture to increase the overall culture positivity. GeneXpert MTB/RIF: Based on the Cepheid GeneXpert platform, a highly sensitive, rapid and simple-to-use nucleic acid amplification test. The Xpert® MTB/RIF purifies, concentrates, amplifies (by real-time PCR) and identifies targeted nucleic acid sequences in the TB genome, and provides results from unprocessed sputum samples in 90 minutes, with minimal biohazard and very little technical training required to operate. This test, endorsed by WHO in December 2010, also identifies resistance to rifampicin. Chest x-ray (CXR): CXRs are used to check for lung abnormalities in people who have signs and symptoms of TB disease in the lungs. Although CXRs may suggest that TB disease is present, a CXR alone cannot definitely diagnose TB. All PLHIV should have a CXR as part of the initial work-up of the respiratory system. The first screening for PTB is still SSM then a CXR is necessary to help in diagnosing PTB. This test is performed according to national protocols on patients when SSM is negative. The other indications for CXR are: suspected complications of PTB (pleural effusion, pneumothorax, pericardial effusion and haemoptysis (coughing up blood)). Specialized tests such as computerized chest tomography and bronchoscopy are not recommended for the routine diagnosis of pulmonary TB. Mycobacterial culture or GeneXpert MTB/RIF testing is especially important among HIV-infected children; pulmonary TB (PTB) in HIV-infected children is often smearnegative. In patients with advanced HIV infection, atypical TB presentation is more common (e.g., non-cavity, lower- and mid-lobe involvement, extrapulmonary disease) alongside with other clinical symptoms such as prolonged fevers and low BMI. The highest risk of extrapulmonary disease is in advanced HIV disease (e.g., when CD4 < 50 cells/mm³); TB meningitis is fatal if untreated thus if suspected, diagnose and treat immediately. When diagnosing TB in HIV-infected individuals, always define the disease classification (site), the type of patient, and their HIV clinical status as recommended Page 27 in national guidelines. TB treatment (SOPs 8 and 10) The first priority for HIV-positive TB patients is to initiate TB treatment, followed by CTX and then ART. TB patients with HIV and all TB patients living in HIV-prevalent settings should receive daily TB treatment at least during the intensive phase. TB patients who are living with HIV should receive at least the same duration of TB treatment as HIV-negative TB patients. Ensure completion of full TB treatment with good adherence. Do not begin a TB treatment trial: decisions to start co-infected patients on TB treatment should be carefully considered and patients should receive a full course of TB treatment once started. Most pulmonary TB patients, including those who are TB-HIV co-infected, can be treated in the outpatient setting, whether the clinic is facility or community-based. If patient is already on ART when TB is diagnosed or suspected, consult to rule out: ART treatment failure, TB re-infection or reactivation, or active TB resulting from immune reconstitution syndrome. In co-infected patients not yet on ART, initiate ART as soon as possible and within the first 8 weeks of starting TB treatment. CTX prophylaxis (SOP 9) As all adults and adolescent with symptomatic HIV infection are eligible for CTX prophylaxis, a patient co-infected with HIV and TB is by definition eligible for CTX prophylaxis. All HIV-exposed and HIV-infected infants and children are eligible for CTX from 4–6 weeks or as soon as possible thereafter CTX prophylaxis is continued until cessation of risk of HIV transmission and exclusion of HIV infection. CTX prophylaxis prevents secondary bacterial, parasitic, and fungal infections. In all HIV-positive TB patients, CTX should be initiated as soon as possible and given throughout TB treatment. A system for providing CTX prophylaxis to all people living with HIV who have active TB should be established by TB and HIV programs. Treatment monitoring (SOPs 11 and 14) Monitoring allows for the assessment of a co-infected individual, as well as a performance evaluation of the clinical site providing TB treatment and ART. Patients are monitored for both response to treatment (SOP 11) and for medication side Page 28 effects (SOP 14). Monitoring for response to treatment: Smear-positive PTB patients (usually adults and adolescents) are monitored for response to treatment using repeated sputum smear microscopy. Smear negative PTB patients should also be monitored by sputum smear microscopy but where available, smear-negative PTB patients may be monitored for response to treatment with sputum mycobacterial culture. Repeat CXRs to monitor response to treatment is not indicated. Sputum smear negative PTB, ETB, and pediatric TB cases are most frequently monitored clinically for response to treatment. A PTB patient is considered non-infectious after 3 consecutive negative sputum smears on 2 different days; the patient may not be infectious after 2 weeks of antiTB treatment and an improvement in symptoms. Reinforce the continuation of hand washing and standard precautions during and after completion of anti-TB treatment. Monitoring for side effects: Monitoring and managing minor medication side effects early can improve adherence; Close monitoring is essential to determine if clinical symptoms or side effects indicate ART failure. INH preventive treatment (SOP 12) INH preventive therapy has been shown to prevent the development of active TB disease in individuals with latent TB infection. TST is not a requirement for initiating INH preventive therapy, however, people living with HIV who have a positive TST benefit more from INH preventive therapy. TST can be used where feasible to identify such individuals. CXR preventive therapy. Active TB disease must be ruled out before prescribing INH. Do not give INH preventive therapy to anyone with active TB disease. CXR is no longer a mandatory investigation before starting INH preventive therapy. Adults and adolescents living with HIV who have an unknown or positive TST status and are unlikely to have active TB should receive at least 6 months of INH preventive therapy as part of a comprehensive package of HIV care. INH preventive therapy should be given to such individuals irrespective of the degree of immunosuppression, and also to those on ART, those who have previously been treated for TB and pregnant women. Promoting and monitoring treatment adherence (SOP 13 and 17) Non-adherence causes drug-resistant TB and treatment failure. Adherence to both anti-TB medicine and ARVs is complicated; a patient-centered approach is needed to Page 29 ensure adherence. Daily directly observed therapy (DOT) is the preferred method to ensure full adherence to TB treatment. The health worker is responsible for making treatment as attractive and organized for the patient as possible. Given training, all types of treatment supporters, including family members, can be trained to provide DOT for both TB treatment and ART. Attention shall be paid when providing adherence support to special populations such as the homeless, people with a poor understanding of their disease, patients with complex medical problems, or substance users. Definitions TB infection control (IC): The goal of TB IC is to minimize the risk of TB transmission by detecting patients with TB disease early, isolating them promptly, and treating them quickly. Personal respiratory protection: Equipment used by health workers in high risk areas and during high risk procedures, as described in the infection control implementation plan, to reduce the airborne spread of TB. Examples of respirators include the following: US-certified N95 (or greater) respirator; EU-certified FFP2 (or greater) respirator; powered air purifying respirators that have a half or full face piece, breathing tube, battery-operated blower, and particulate filters (HEPA only). Respirators: Restrict use to specific high-risk areas, such as rooms where diagnostic incentive spirometry or bronchoscopy are performed, or specialized MDR-TB treatment centers, sputum induction rooms, TB clinic; Require specialized training to fit (e.g., N95 facemask) or operate correctly; Work best with other environmental controls alongside proper work practices. Equipment that prevents TB transmission from the TB-infected patient: Face/surgical masks: Help prevent TB transmission from the patient wearing the mask to others by capturing the large wet particles near the mouth and nose. Health workers should not use a face mask as a TB prevention method when working with TB suspects: Face masks only reduce transmission from symptomatic person(s) to others; The best prevention of TB transmission occurs when TB suspects are diagnosed promptly, started immediately on the correct TB drugs, and the drugs are taken by patients exactly as prescribed. In this way patients usually become noninfectious in a week or 2. Paper tissues: Tissues are less costly than masks but less likely to be used correctly. Tissue use does not readily mark one as a TB suspect, so may be less stigmatizing. Natural ventilation: Ventilation created by the use of external natural forces such as Page 30 wind and temperature. Control of airflow direction cannot be achieved by simple natural ventilation and is dependent upon sufficient wind speed or direction, or temperature differential. Mechanical ventilation: Ventilation created by using a supply and/or an exhaust fan to force air exchange and to drive airflow. It works by generating negative or positive pressure in the room to drive air changes. To be effective, all doors and windows must be kept closed with controlled air leakage into or out of the room. Policy Every health facility should have an IC implementation plan that describes the appropriate activities and measures for the health center that will ensure health worker and patient safety. Adults and adolescents living with HIV should be screened for TB with a clinical algorithm and those who do not report any one of the symptoms of current cough, fever, weight loss or night sweats are unlikely to have active TB and should be offered INH preventive therapy. The provision of INH preventive therapy should not be viewed as an isolated intervention for people living with HIV. Rather, it should be part of a TB prevention package along with infection control for TB and provision of ART. The new WHO guidelines strongly recommend at least six months of INH preventive therapy for children and adults including pregnant women, people living with HIV, those receiving ART, and those who have successfully completed TB treatment. IPT for a duration of 36 months is conditionally recommended in settings with a high transmission of TB among people living with HIV. The risk of developing TB is between 20 and 37 times greater in people living with HIV than among those who do not have HIV infection. TB is responsible for more than a quarter of deaths in people living with HIV. People living with HIV who are coinfected with TB need quality care and treatment urgently. TB treatment should be started immediately and ART initiated as soon as the patient is clinically stable on TB treatment, potentially in 2 weeks. WHO recommends drug susceptibility testing (DST) at the start of therapy for all previously treated patients. Finding and treating multidrug-resistant TB (MDR-TB) in previously treated patients will help to improve the very poor outcomes in these patients. Responsibility at health facility See “Part 1: Organization of TB services in HIV care and treatment settings”. Page 31 SOP 5: TB infection control Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To ensure the provision of IC measures to reduce risk of workplace TB transmission. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management All other clinical and non-clinical staff Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. TB treatment referral/transfer form (Appendix 3), any other forms required by site protocol or national guidelines 3. Equipment/supplies: a. Face/surgical masks b. Paper tissues c. Personal respiratory protection 4. IC assessment form (Appendix 5) 5. Written instructions on how to correctly collect sputum (Appendix 6) Procedure 5.1 Management of the Implementation of infection control measures Organize a TBIC Steering Committee to develop TBIC policies and procedures. The Steering Committee will be responsible for: Identifying a person with basic knowledge in IC, architecture or engineering to lead the Steering Committee; Carrying out a risk assessment to identify risk of TB transmission to patients and health workers in the clinic; Developing a TBIC plan based on findings from the risk assessment (see Appendix 5); Page 32 Including civil society involvement, behavioral change campaigns, and reinforcement of positive messages for health workers, patients, and visitors in the TBIC plan; Ensuring the inclusion of clinic management and staff in creating a feasible IC plan. (A sample IC plan is presented in Annex A.1, “Sample infection control plan” in the document entitled: “TUBERCULOSIS INFECTION CONTROL IN THE ERA OF EXPANDING HIV CARE AND TREATMENT, Addendum to WHO Guidelines for the Prevention of Tuberculosis in Health Care Facilities in Resource-Limited Settings, 1999” available at: http://www.who.int/tb/publications/2006/tbhiv_infectioncontrol_addendum.pdf); Working with local coordinating bodies, including human resources, in the implementation of the TBIC plan; Participating in research efforts to improve the TBIC plan; Rethinking the use of available spaces and considering renovation of patient flow or the health facility, as able, to optimize the implementation of IC measures; Designing the entire health facility, particularly the waiting areas and examination rooms to take advantage of natural ventilation. Monitor and evaluate the TBIC plan: The TBIC Steering Committee lead is responsible for supervising and monitoring the IC plan; The TBIC Steering Committee meets annually to assess the plan. Schedule annual all-staff training about TB, TB infection control, and the clinic’s TBIC plan. 5.2 Implement administrative control measures Promptly identify potential and known infectious cases of TB; separate and treat with minimal delay. Initiate IC at triage and screening: Educate all patients and health workers on proper cough etiquette and cough hygiene; Upon arrival, screen all patients in a well-ventilated area, identify those with a cough, and direct them for expedited services (triage staff); Explain to patients that the goal of IC is safety without stigma and that screening for and prevention of TB is part of providing quality care; If symptomatic, initiate IC measures as described below; Post educational flyers about infection control measures in waiting areas, procedure rooms, and other areas where they will be seen by patients and staff. Page 33 Encourage proper cough hygiene (it is the duty of all staff to help patients adhere to proper cough hygiene and etiquette): Ask the coughing person to cover their mouth and nose when they cough or sneeze and to wash hands often. For outpatients: Provide face masks, tissues, or disposable cloth scraps to TB suspects for immediate use. If a face mask is available, give to TB suspect to wear over their mouth and nose until they leave the clinic; If tissues or cloth scraps are available, instruct TB suspects to cover their mouth and nose when coughing or sneezing. For inpatients: Provide face masks, tissues, or disposable cloth scraps to TB suspects or those with active disease to use when: Leaving isolation areas to complete procedures in other areas of the hospital; Receiving care from a health worker. Place TB suspects in a separate or designated area. Follow national or facility protocols; If the TB suspect is an inpatient, place the person in a separate, well-ventilated room. If this is not possible, place the TB suspect in a separate ward far away from HIV-infected inpatients; If the TB suspect is an outpatient, a designated facility staff should fast-track TB suspects to receive care and attention from the clinical staff as soon as possible: Move suspects to the front of the queue for the services they require (e.g. medication refills, medical evaluation); When collecting sputum samples, collect the specimen in a designated procedure room or an open environment, away from other people. Do not collect sputum samples in enclosed spaces such as bathrooms, or toilets. Wash hands between each patient interaction Ensure a rapid diagnosis process and initiation of treatment: Follow up daily on sputum smear and culture results (if available), whether testing was conducted on site or at another facility (ideal turnaround time for sputum acidfast bacilli (AFB) is less than 24 hours); Evaluate chest X-ray (CXR) results as soon as available; Monitor TB suspect frequently according to national guidelines; Discuss diagnosis and treatment plan with patient and family; Implement and monitor daily directly observed therapy (DOT); Initiate isoniazid (INH) preventive therapy in accordance with national Page 34 guidelines (SOP 12). Offer screening for potential contacts of TB suspects, including household contacts, symptomatic contacts, and visitors accompanying a TB suspect. Screen all staff for TB disease: Periodically screen staff for symptoms of active TB disease; Schedule all-staff TB testing twice a year in high TB and HIV-prevalence areas. This testing will depend on national policy guideline, but should at a minimum include symptom screening with smear microscopy for health workers suspected of having TB; Document results in staff files. In high-burden TB and HIV settings, test all health workers for HIV in addition to TB: Offer staff voluntary, confidential HIV counseling and testing, and annual repeat testing if HIV-negative on previous occasions; Refer staff members living with HIV for assessment of readiness for and preferential access to CTX and ART; INH preventive therapy as indicated by national policy guidelines (SOP 12). Do not assign HIV-infected health workers to work in high-prevalent TB settings, if possible. Prevent HIV-infected health workers from coming in contact with: Patients assessed for but not yet diagnosed with TB, such as in outpatient department waiting rooms and emergency departments; Sputum collection procedures; Bronchoscopy; Routine laboratory test site for diagnosing TB; Autopsy area; Inpatient medical, pediatric, and TB wards. 5.3 Implement environmental control measures Use environmental control measures together with the recommended clinic practices to reduce the transmission of TB bacilli. Dilute the concentration of TB bacilli in the room by using (tailor environmental controls to local climatic and socioeconomic conditions): Natural ventilation: Use in inpatient wards, outpatient clinic waiting rooms, and rooms used for sputum collection and cough-inducing procedures; Page 35 Weather permitting, arrange for sputum collection to be done outdoors; In warm climates, use an open-air shelter with a roof to protect patients from sun and rain; If indoors, keep clinic doors and windows on opposite sides of the area open to bring in air from the outside. Mechanical ventilation: Use propeller fans mounted in ceilings or in a window opening to distribute and direct airflow; Ensure that the air flows across the room if used in a high-risk area; place the fan behind the health worker and direct air past the health worker, past the TB suspect, and out the window; Develop a plan to ensure regular maintenance of equipment. Filtration and ultraviolet germicidal irradiation, where it is affordable and can be periodically serviced and cleaned: Use this method in referral hospitals in combination with natural and/or mechanical ventilation methods. Implement additional IC measures in sputum collection rooms: Post written instructions on how to correctly collect sputum; (Appendix 6) Whenever possible, sputum should be collected outdoors, in a covered area that is well-ventilated and away from other patients; Instruct patient to stay in the area until that episode of coughing stops. 5.4 Implement respiratory control measures for all health workers and administrative staff Use respirators in high-risk areas, such as rooms where diagnostic incentive spirometry or bronchoscopy are performed, or specialized MDR-TB treatment centers, sputum induction rooms, TB clinic. Combine the use of respirators with environmental control measures alongside proper work practices. Avoid using face masks (face masks are not effective in protecting health workers, they should be used only to reduce transmission from the symptomatic person(s) to others). Page 36 SOP 6: TB screening in HIV-infected individuals Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To screen for symptoms of TB as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Supplies 1. National TB screening forms (See Appendices 7, 8, and 9 as examples), medical record, HIV Care/ART Card, and relevant registers (e.g., TB register) as per national guidelines 2. TB treatment referral/transfer form (Appendix 3), any other forms required by site protocol or national guidelines 3. Equipment/supplies: a. Stethoscope b. Thermometer c. Weighing scale d. Face mask for TB suspects (if available) e. Specimen cups 4. BMI chart 5. Area to isolate TB suspects 6. Laboratory test referral request form if required Procedure Check vital signs. Note and record all findings in medical record. Assess history. Infants and children: Determine if the child has had close contact with active or suspected TB patients; Page 37 Ask about the general health of friends, family, caretakers, and specifically the mother if the TB suspect is an infant; Ask about current/past medical history: Prior TB exposures, especially to persons with sputum-positive pulmonary TB; Prior TB treatments; History of pulmonary disease or infection (e.g., asthma, pneumonia), heart failure; History of previous clinical presentations of recurrent lung disease(s). Adults: Determine if the adult has had close contact with active or suspected TB patients; Ask about the general health of friends, family, occupation (e.g. miner, agricultural worker, factory worker, health worker, corrections officer), and current living situation (e.g., group home, homeless, prison, hostel, other crowded conditions); Ask about current/past medical history: History of TB; Family history of TB; History of asthma, bronchitis or COPD, heart failure; Ask if patient smokes; Ask if he/she is currently taking TB treatment; All clients (infants, children and adults): If the patient is not taking TB treatment, screen for TB using the national TB screening forms: (see Figures 1 and 2) Screen all HIV-infected infants, children, adolescents, and adults at each visit; (whether an acute or scheduled chronic HIV care visit, or acute hospitalization) For children, screen for (as a minimum): cough (any duration), fever, poor weight gain and contact history with TB case; (A sample screening questionnaire can be found in Appendix 7) For adults, screen for (as a minimum): cough (any duration), fever, weight loss, and night sweats; (A sample screening questionnaire can be found in Appendix 8 and 9) Conduct a thorough “head-to-toe” physical exam, evaluate for physical signs of TB: Infants and children: Always examine the respiratory and cardiac systems; Presentation of auxiliary lymphadenopathy on the same side as the BCG should alert clinician to rule out BCG disease. Adults and adolescents: Always examine the respiratory and cardiac systems. If patient responded positively to any 1 or more of the screening questions for TB, he or she is considered a suspect or symptomatic: Initiate and explain to patient and family TBIC measures; Page 38 Determine the severity of disease; For infants and children only, perform a TST ; Provide or refer for diagnostic evaluation. If patient responded negatively to all of the screening questions for TB, Offer INH preventive therapy according to national guidelines and protocol (SOP 12). Schedule follow-up visit; record appointment in follow-up register. Document: Document screening procedures and results in patient’s medical record ; Complete all relevant registers (e.g., TB suspect register) as per national guidelines; Complete paperwork for laboratory tests or other referrals, if applicable. Page 39 Figure1: Algorithm for TB screening in children with HIV in HIV-prevalent and resource constrained settings Child more than 12 months of age and living with HIV* UNCLEAR GRAMMAR: Screen for TB with any 1 of the following symptoms: Poor weight gain** Fever Current cough Contact history with a TB case NO YES Assess for contraindications to INH preventive therapy*** NO Give INH YES Defer INH Investigate for TB and other diseases**** Other diagnosis Give appropriate treatment and consider INH Not TB TB Follow up and consider INH Treat for TB Screen regularly for TB Footnotes to Algorithm for Children * All children and infants less than 1 year of age should be provided with INH preventive therapy if they have a history of household contact with a TB case. ** Poor weight gain is defined as reported weight loss, or very low weight (weight-for-age less than -3 zscore), or underweight (weight-for-age less than -2 z-score), or confirmed weight loss (>5%) since the last visit, or growth curve flattening. *** Contraindications include: active hepatitis (acute or chronic) and symptoms of peripheral neuropathy. Past history of TB should not be a contraindication for starting INH preventive therapy. Although not a requirement for initiating INH preventive therapy, TST may be done as a part of eligibility screening in some settings. **** Investigations for TB must be done in accordance with existing national guidelines. Source: World Health Organization (2011). Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. Page 40 Figure 2: 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 1 of the following symptoms:** Current cough Fever Weight loss Night sweats NO Assess for contraindications to INH preventive therapy*** NO Give INH YES Defer INH YES Investigate for TB and other diseases**** Other diagnosis Give appropriate treatment and consider INH Not TB TB Follow up and consider INH Treat for TB Screen for TB regularly at each encounter with a health worker or visit to a health facility Footnotes to Algorithm for Adults * 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 non-TB 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, TST may be done as a part of eligibility screening in some settings. **** Investigations for TB should be done in accordance with existing national guidelines. Source: World Health Organization (2011). Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. Page 41 SOP 7: TB diagnosis in HIV-infected individuals Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To diagnose TB using laboratory testing in combination with physical findings and CXR as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Radiologist Laboratory staff Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. TB treatment referral/transfer form (Appendix 3), any other forms required by site protocol or national guidelines 3. Equipment/supplies: a. Nasal canula b. Oxygen face mask c. Non-rebreather mask d. Clinical diagnostics materials (e.g., stethoscope, thermometer) e. Sputum collection container 4. CTX, ARV and TB medications 5. Request for Sputum Smear Microscopy Examination Form (Appendix 10) and any other laboratory forms Procedure 7.1 Collect and submit sample Collect 2 or 3 consecutive (8 hours apart) expectorated sputum specimens using either 1 of the following methods, according to national guidelines and site protocols (WHO policy on case detection by microscopy was revised in 2007 to recommend a reduction in the number of specimens examined, from 3 to 2 in settings with Page 42 appropriate external quality assurance and documented good-quality microscopy): Expectorated sputum Obtain any expectorated sputum sample in a well-ventilated room, outside, or in a room designated and designed for sputum collection; Instruct child (and parent/family member monitoring child) on how to vigorously cough up a specimen into the specimen cup; see Table 4 Obtain 2 sputum specimens (spot-spot) in children able to produce a specimen: an “on-the-spot” specimen (at first evaluation) and a second “on-the-spot” specimen few hours after the first specimen. Gastric aspiration: collect a gastric aspirate sample from a young child unable or unwilling to expectorate sputum; but do not perform gastric aspiration procedure if child has a low platelet count or a bleeding disorder: Conduct this procedure first thing in the morning at the child’s bedside, in a routine procedure room, or as an outpatient if supplies are available, using a nasogastric tube per facility protocol. (Gastric aspiration in children is generally considered a low risk procedure for TB transmission as young children are at low risk of transmitting disease); Obtain 1 gastric aspirate on 2 consecutive mornings. Sputum induction: is safe and effective in children of all ages; bacterial yields are as good as or better than for gastric aspirates: Training and specialized equipment are required to properly perform this procedure; Do not perform in children with severe respiratory distress, intubation, bleeding disorders, decreased level of consciousness, or a history of significant asthma. Label and send specimens to the lab for sputum smear microscopy and, where possible, for mycobacterial culture or GeneXpert MTB/RIF testing. Work with trained facility staff to transport specimens to the laboratory with forms to “Request for Sputum Smear Microscopy Examination” or “Request for Sputum Smear Microscopy, Culture, Drug Susceptibility Test.” Request CXR if recommended by national and site protocol. CXR does not need to be done in all HIV-infected adult/adolescent TB suspects. Diagnosis should be made on the basis of laboratory testing, and CXR should be reserved for those cases where laboratory testing is inconclusive, or if complications (pleural/pericardial effusion, compressive Left Anterior Descending (LAD), pneumothorax) are suspected. See Table 5, below Follow up to ensure results are returned in a timely manner and that they are documented in patient medical record. 7.2 Interpret POSITIVE sputum sample results Page 43 Diagnose HIV-infected infants and children with smear-positive, infectious pulmonary TB if: (see Figure 3) Two or more initial sputum smear exams are AFB positive, or One sputum smear exam is AFB positive, plus clinician decides that CXR abnormalities are consistent with active PTB, or One sputum smear exam is AFB positive, plus sputum culture is positive for M. tuberculosis. Diagnose HIV-infected adults and adolescents with smear-positive, infectious pulmonary TB if one of the smear sample is positive. Always confirm PTB diagnosis based on sputum smear-positive results with culture positive results for Mycobacterium tuberculosis. Stage as WHO clinical stage 3 any HIV-positive patient diagnosed with smearpositive pulmonary TB. 7.3 Interpret NEGATIVE sputum results If all sputum samples are negative, the HIV-infected person may or may not have TB; sputum smear microscopy is generally negative in a person with severe immune suppression. If patient’s symptoms improve on broad-spectrum antibiotics, sputum results are negative, and CXR does not indicate TB disease, do not diagnose patient with TB: Continue treatment with previously chosen non-specific antibiotic such as CTX or Amoxicillin with appropriate medication according to national protocol; Discontinue TBIC measures; Document negative TB results in patient’s medical record; Monitor response to completed antibiotic regimen; Continue TB screening at each clinical visit. Consider the need for INH preventive therapy (SOP 12). If patient’s symptoms do not improve, patient still coughs but cannot produce sputum for examination, or has other general complaints, rule out smear-negative TB and extrapulmonary TB. (see “Diagnose smear-negative pulmonary TB”, below) 7.4 Diagnose smear-negative pulmonary TB Confirm that all sputum specimens for that particular patient returned smear-negative for AFB. Review CXR for radiographic abnormalities consistent with active tuberculosis. Confirm that patient is not responsive to a course of broad-spectrum antibiotics. Page 44 If a decision is made that the patient has smear-negative pulmonary TB, stage the co-infected individual as WHO clinical stage 3. Confirm diagnosis with culture-positive results for Mycobacterium tuberculosis, if available. 7.5 Complete the consultation If extrapulmonary and disseminated TB is suspected, coordinate a full exam (radiology and biopsy of extrapulmonary site) for interpretation (Figure 4). Once active TB has been diagnosed, discuss the TBIC plan depending on diagnosis, location and site of TB; educate patient and family about individualized IC measures as indicated by diagnosis. If possible, conduct rapid, baseline drug susceptibility testing (DST) for initial MDR-TB. Screen using Sputum Smear Microscopy, Culture, Drug Susceptibility Test to avoid mortality from undiagnosed drug-resistant TB (SOP 16). Determine TB type: review all diagnostic data alongside with clinical exam and determine TB diagnosis: PTB: sputum-smear positive or sputum-smear negative; ETB; Other (combination of PTB and ETB). Using data collected so far, match the patient to 1 of the following categories: New: A TB treatment-naive patient; Taken anti-TB drugs for less than 1 month; Relapse: Previously TB-treated patient and Determined cured in past or completed TB treatment and Diagnosed with smear or culture-positive for TB Treatment after failure: Previously TB-treated patient and Determined to have failed the previous treatment course and Diagnosed with smear- or culture-positive TB Treatment after default: Returned to treatment and Positive for TB (could be ETB or smear-negative TB); Page 45 Treatment interruption of 2 or more consecutive months. Transfer-in: Transfer patient from another TB register; Needs to continue TB treatment after interruption of <2 months. Other previously treated: Any case not meeting any of the categories above (new, relapse, treatment after failure, treatment after default or transfer in). Includes sputum smear microscopy-positive cases with unknown history or unknown outcome of previous treatment. Previously-treated who are currently sputum smear microscopy-negative. Previously-treated ETB. Chronic case at the end of re-treatment regimen. Provide referrals, as needed. Schedule regular clinical and adherence visits and record appointment in follow up register. Document: Record all findings, prescribed medications and discussions in TB Treatment Card, HIV Care/ART Card, and medical record; Complete all relevant registers as per national guidelines; Complete paperwork for laboratory tests or other referrals, if applicable. Page 46 Table 4: Expectorated sputum Expectorated sputum procedure Explain the reason for collecting sputum. Instruct the patient to rinse her mouth with water before producing the specimen. Instruct the patient to take a deep breath, hold the breath for a few seconds and then exhale slowly. Repeat 2 times. After the third inhale, instruct the patient to forcefully blow the air out. Ask the patient to breathe in a fourth time and then cough; this should produce sputum from deep in the lungs. Ask the patient to hold the sputum container close to the lips and spit into it gently after a productive cough. If the sputum coughed up is not enough to send for the test, ask the patient to cough again until a good specimen is in the container. If the patient cannot bring up sputum from a cough, consider the container used and safely dispose of it. Source: WHO: Guidance for national tuberculosis programmes on the management of tuberculosis in children Table 5: CXR findings in HIV-infected adults and children with PTB CXR findings in Pediatric HIV with PTB Cavitation (unusual in young children; more common in older children and adolescents) Persistent opacification Enlarged perihilar lymph nodes Focal abnormalities Miliary TB Diffuse, bilateral, micronodular, evenly distributed small military shadows (different from LIP) CXR findings in HIV infected adults with PTB Mild HIV-disease: Cavitation Upper lobe infiltrates Advanced HIV-disease: “Atypical” Interstitial infiltrates especially in lower zones Intrathoracic lymphadenopathy Lack of cavitation No abnormalities Pleural + pericardial involvement Sources: WHO (2004). TB-HIV: A Clinical Manual, Second Edition. WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for National Tuberculosis and HIV Programmes on the management of Tuberculosis in HIV-infected Children: Recommendations for a Public Health Approach. Page 47 Figure 3: Algorithm for the diagnosis of tuberculosis in ambulatory HIV positive patient in HIV-prevalent settings Ambulatory patient with cough 2–3 weeks and no danger signsa st 1 Visit AFB HIV testb HIV+ or status unknownc AFB-negatived Provide CTX HIV assessment e TB likely 2 CXRf Treat for TB nd Visit AFB-positived Spunum AFB and culturef Clinical assessmentf infectiong HIV assessmente Provide CTX Ewhich box is to be used this one or the one to the right? No or partial response Responsei th Responsei 4 Visit HIV assessment Treat for bacterial rd Treat for PCPh 3 Visit TB unlikely Reassess for TB a. The danger signs include any 1 of: respiratory rate >30/minute, fever >39 ºC, pulse rate >20/min and unable to walk unaided. b. For countries with adult HIV prevalence rate 1% or prevalence rate of HIV among tuberculosis patients 5%. c. In the absence of HIV testing, classifying HIV status unknown as HIV-positive depends on clinical assessment or national and/or local policy. d. AFB-positive is defined at least 1 positive and AFB-negative as 2 or more negative smears. e. HIV assessment includes HIV clinical staging, determination of CD4 count. . Page 48 f. The investigations within the box should be done at the same time wherever possible in order to decrease the number of visits and speed up the diagnosis. g. Antibiotics (except fluoroquinolones) to cover both typical and atypical bacteria should be considered. h. PCP: Pneumocystis carinii pneumonia, also known as Pneumocystis jirovecii pneumonia. i. Advise to return for reassessment if symptoms recur. Source: WHO (2007). Improving the diagnosis and treatment of smear-negative pulmonary and extrapulmonary tuberculosis among adults and adolescents: Recommendations for HIV-prevalent and resource-constrained settings. Page 49 Figure 4: Suggested clinical characteristics to assist the diagnosis of extrapulmonary tuberculosis (ETB) in adolescents and adults Suspect ETB in patients with Look and listen for Cough for 2 weeks or more or Unintentional weight loss with Night sweats and Temperature >37.5 °C or feels feverish Breathlessness (effusion/pericarditis) or Enlarged glands in neck/armpit or Chest X-ray Miliary or diffuse shadowing Large heart (especially if symmetrical and rounded) Pleural effusion Enlarged lymph nodes inside the chest Chronic headache or altered mental state Suspect disseminated tuberculosis in all people living with HIV who experience rapid or marked weight loss, fever and night sweats Lymph nodes swelling in the neck or armpits (if present with other types of ETB it may provide the only way to confirm the diagnosis) Possible tuberculosis lymphadenitis Signs of fluid in the chest Absent breath sounds Reduced chest wall movement Dull to percussion Possible tuberculosis pleural effusion Signs of fluid around the heart Heart sounds distant Swollen legs and/or abdomen Neck and hand veins distended with arm held above the shoulder Possible tuberculosis pericarditis Signs of meningitis Neck stiffness Confusion Abnormal eye movements Possible tuberculosis meningitis Establish HIV status if ETB is suspected Advise and arrange for rapid HIV testing if status is unknown or last test was negative Explain that this will affect the way that this illness is investigated and treated Discuss the need for antiretroviral treatment if HIVrelated tuberculosis is diagnosed If consent is given, try to arrange testing on the same day Source: WHO (2007). Improving the diagnosis and treatment of smear-negative pulmonary and extrapulmonary tuberculosis among adults and adolescents: recommendations for HIV-prevalent and resource-constrained settings Page 50 SOP 8: TB treatment Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To provide treatment for TB according to national guidelines, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Pharmacist Treatment supporter Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. CTX, ARV and TB medications 3. Laboratory test referral request form if required Procedure 8.1 Provide treatment for adults and adolescents Confirm if the patient is on ART: If on ART, begin anti-TB medications that do not interact with patient’s ART regimen (to minimize drug-drug interaction) as per national guidelines. Consult TB-HIV specialist as needed. If not on ART, initiate TB treatment immediately and ART as soon as TB treatment is tolerated, usually within 2–88 weeks of starting TB treatment. (see Table 12, SOP 10) If not on ART, and a women of childbearing age: If pregnant or is trying to get pregnant (provide pregnancy testing if appropriate): » Do not use streptomycin because it can cause deafness in the baby; » Provide or refer for antenatal care and PMTCT interventions; » If possible, delay ART initiation until the second trimester of pregnancy, then Page 51 initiate an EFV-based regimen. If breastfeeding: » In accordance with PMTCT guidelines regarding safer infant feeding options, encourage the mother to continue exclusive breastfeeding the usual way; » Provide infant with INH preventive therapy (SOP 12); » Once the infant’s preventive therapy is complete, check infant’s immunization record and provide BCG immunization to infant if not already provided. If not pregnant but sexually active, provide family planning counseling and supply with (or provide referral for) contraceptives of choice. Consider drug-drug interactions between rifampicin, oral contraceptives, and certain antiretroviral drugs (ARVs) such as non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). Choose the TB treatment regimen; refer to Table 6 for the treatment regimen for new cases of TB and Table 7 for previously treated cases. Refer to SOP 10 for more information on the co-treatment of TB and HIV. 8.2 Provide treatment for infants and children Confirm if patient is on ART. If on ART, begin anti-TB medications that do not interact with the patient’s ART regimen (see SOP 10). Consult TB-HIV specialist as needed; If not on ART, initiate TB treatment immediately and ART as soon as TB treatment is tolerated, usually within 2–8 weeks of starting TB treatment. (see Table 12, SOP 10) Choose the pediatric TB treatment regimen according to national guidelines. See also Table 8, below For active TB cases, choose 3–4 drugs, according to national guidelines: Ethambutol is safe to use in children when dose is adjusted (Table 8); Avoid streptomycin when possible: » Injections are painful; irreversible auditory nerve damage may occur; » Reserve streptomycin use for the first 2 months of TB meningitis treatment; Treat child with rifampicin for the entire treatment duration, if possible; Prescribe daily (7 days per week) treatment regimen for both intensive and continuation phases. 8.3 Support the treatment regimen Once a regimen is chosen, review the length of treatment and the difference between Page 52 the 2 treatment phases. Discuss and arrange DOT: Identify a community treatment supporter; If the patient has a supporter for ART, include supporter in the conversation about anti-TB medication. If patient is in agreement, invite the person to provide TB treatment support as well; Screen the treatment supporter for TB at regular intervals. Review side effects of chosen medication regimen and discuss which symptoms require immediate return to the clinic. Describe and review the follow-up schedule. Dispense medications or ensure access to a pharmacy. If the patient is not already on ART, plan for ART initiation. Planning should start as soon as TB treatment is initiated, since ART should start 2–88 weeks later. 8.4 Conduct drug susceptibility testing Where available, conduct DST in all sputum smear-positive persons living with HIV at the start of TB treatment. DST identifies drug-resistant TB; testing should be conducted using rapid DST, when possible. If the country is introducing DST, but does not yet have the resources to test all HIVpositive TB patients, prioritize the following patients for DST (at the start of TB treatment): Patients with previously treated TB, whose prior TB treatment has failed; Patients with previously treated TB who have relapsed; Patients with previously treated TB who are returning from default. 8.5 Schedule follow up and document Schedule regular clinical and adherence visits (see SOP 11): Schedule earlier appointment if required; Record appointment in follow-up register. Document: Record all findings, assessment, plan, and prescribed medications in TB Treatment Card, HIV Care/ART Card, in medical record; Complete all relevant registers as per national guidelines; Report the patient’s diagnosis and initiation of treatment plan to the NTP; Page 53 Complete paperwork for laboratory tests or other referrals, if applicable. Table 6: Standard regimen and dosing frequency for new TB patients (adults and children >12 years) Intensive phase 2 months of HRZEa Continuation phase 4 months of HR Comments 2 months of HRZE 4 months of HRE Applies only in countries with high levels of INH resistance in new TB patients, and where INH drug susceptibility testing in new patients is not done (or results are unavailable) before the continuation phase begins. a. WHO no longer recommends omission of ethambutol during the intensive phase of treatment for patients with non-cavitary, smear-negative pulmonary TB or extrapulmonary disease who are known to be HIV-negative. E= ethambutol; H = isoniazid; R = rifampicin; S = streptomycin; Z = pyrazinamide. Dosing frequency Intensive phase Daily Continuation phase Daily Comments Optimal Daily 3 times per week Acceptable alternative for any new TB patient receiving DOT 3 times per week 3 times per week Acceptable alternative provided that the patient is receiving DOT and is NOT living with HIV or living in an HIV-prevalent setting Note: Daily (rather than 3 times weekly) intensive-phase dosing may help to prevent acquired drug resistance in TB patients starting treatment with INH resistance. Source: WHO (2009). Treatment of Tuberculosis Guidelines, Fourth Edition. Page 54 Table 7: Standard regimens for previously treated patients depending on the availability of routine DST to guide the therapy of individual retreatment patients DST Routinely available for previously treated patients Likelihood of MDR(patient registration groupa) High (failureb) Medium or low (relapse, default) Rapid molecular-based method DST results available in 1–2 days confirm or exclude MDR to guide the choice of regimen While awaiting DST resultsc: Conventional method None (interim) Empirical MDR regimen Regimen should be modified once DST results are available 2HRZES/HRZE/5HRE Regimen should be modified once DST results are available Empirical MDR regimen Regimen should be modified once DST results or DRS data are available 2HRZES/HRZE/5HREfor full course of treatment. Regimen should be modified once DST results or DRS data are available a. The assumption that failure patients have a high likelihood of MDR (and relapse or defaulting patients a medium likelihood) may need to be modified according to the level of MDR in these patient registration groups (for additional information, see Section 3.8 in Treatment of Tuberculosis Guidelines, Fourth Edition). b. And other patients in groups with high levels of MDR. One example is patients who develop active TB after known contact with a patient with documented MDR-TB. Patients who are relapsing or returning after defaulting from their second or subsequent course of treatment probably also have a high likelihood of MDR. c. Regimen may be modified once DST results are available (up to 2–3 months after the start of treatment). Notes: 1. A country’s standard MDR regimen is based on country-specific DST data from similar groups of patients. 2. In the country’s standard regimens, the 8-month retreatment regimen should not be “augmented” by a fluoroquinolone or an injectable second-line drug; this practice jeopardizes second-line drugs that are critical treatment options for MDR patients. Second-line drugs should be used only for MDR regimens and only if quality-assured drugs can be provided by DOT for the whole course of therapy. In addition, there must be laboratory capacity for cultures to monitor treatment response, as well as a system for detecting and treating adverse reactions (see an HIV-TB specialist for further information) before embarking on MDR-TB treatment. Source: WHO (2009). Treatment of Tuberculosis Guidelines, Fourth Edition. Page 55 Table 8: Recommended pediatric TB treatment regimen TB diagnostic category III Regimena TB Cases New smear-negative pulmonary (other than in category I). Intensive phase Continuation phase 2HRZb 4HR or 6HE 2HRZE 4HR or 6HEc Less severe forms of extrapulmonary TB I New smear-positive pulmonary TB. New smear-negative pulmonary TB with extensive parenchymal involvement. Severe forms of extrapulmonary TB (other than TB meningitis — see below). Severe concomitant HIV disease. I TB meningitis 2RHZSd 4RH II Previously treated smear-positive pulmonary TB: 2HRZES/1HRZE 5HRE Relapse Treatment after interruption Treatment failure IV Chronic and MDR-TB Specially designed standardized or individualized regimens (see HIV-TB specialist or WHO’s Guidance for national tuberculosis programmes on the management of tuberculosis in children) E= ethambutol; H = isoniazid; R = rifampicin; S = streptomycin; Z = pyrazinamide. a. Direct observation of drug administration is recommended during the initial phase of treatment and whenever the continuation phase contains rifampicin. b. In comparison with the treatment regimen for patients in diagnostic category I, ethambutol may be omitted during the initial phase of treatment for patients with non-cavitary, smear-negative pulmonary TB who are known to be HIV-negative, patients known to be infected with fully drug-susceptible bacilli and young children with primary TB. c. This regimen (2HRZE/6HE) may be associated with a higher rate of treatment failure and relapse compared with the 6-month regimen with rifampicin in the continuation phase. d. In comparison with the treatment regimen for patients in diagnostic category I, streptomycin replaces ethambutol in the treatment of TB meningitis. Source: WHO (2006). Guidance for national tuberculosis programmes on the management of tuberculosis in children. Page 56 SOP 9: CTX prophylaxis to HIV positive patient with active TB disease Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To provide CTX prophylaxis according to national guidelines, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Community health worker Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB and HIV registers) as per national guidelines 2. CTX, ARV and TB medications 3. Laboratory test referral request form if required Procedure Assess patient for sulfa allergy or previous history taking any sulfa-based drug and consider alternatives if a patient allergy is documented. Prescribe CTX according to national guidelines if no sulfa-based drug allergy is reported or documented (Table 9). Review dose and possible side effects with the patient: Discuss with treatment supporter and patient giving CTX prophylaxis at the same time as the TB meds; Review the overall tolerability. CTX prophylaxis is generally well-tolerated in children. Side effects are more common in adults. Clinical symptoms of CTX prophylaxis include shortness of breath, nausea, rash, pallor and jaundice; Instruct patient to stop CTX and go immediately to the facility for evaluation for side effects such as generalized rash, pallor changes, bleeding gums, new jaundice; Provide the patient with a 1-month supply if not in a DOT program; schedule a follow-up appointment for the week before the CTX supply runs out. Page 57 Continuation after TB treatment is completed should be considered according to national guidelines. At every monthly visit: Monitor and document CTX adherence; Monitor side effects. Discontinue CTX according to national protocol/guideline and with following events: Side effect/drug reaction/toxicity shows: Liver damage (e.g., jaundice); Bone marrow suppression (severe anemia or leukopenia); Other serious condition (Stevens-Johnson syndrome). CD4 rises above national protocol threshold. HIV-infected children in resource-limited settings where there is a high risk of bacterial infections and malaria should be continued on CTX indefinitely irrespective of immune recovery. Schedule routine follow-up: Schedule a follow-up appointment not longer than 1 month away to monitor and provide prescription refill; Schedule earlier appointment if required to initiate ART or to follow up problems identified during the visit; Record appointment in follow-up register. Document: Document CTX prophylaxis status in the medical record and on the HIV/ART Card and in medical record; Complete all relevant registers as per national guidelines. Page 58 Table 9: Recommended doses of CTX by age and weight Recommended daily dosage based on age or weight (see legend) <6 months 6 months to 5 years 6–14 years >14 years Child tablet (100mg/20mg) Single strength adult tablet 400mg/80mg) Double strength adult tablet (800mg/160mg) 2.5ml 1 tablet ¼ tablet – 5–15kg 5ml 2 tablets Half tablet – 15– 30kg 10ml 4 tablets 1 tablet Half tablet >30kg – – 2 tablets 1 tablet Suspension (5ml syrup of 200mg/40mg) <5kg Recommended frequency = once a day Daily dosages based on age or weight: < 6 months or < 5 kg 100mg sulfamethoxazole / 20mg trimethoprim 6 months – 5 years or 5–15 kg 200mg sulfamethoxazole / 40mg trimethoprim 6–14 years or 15–30 kg 400mg sulfamethoxazole / 80mg trimethoprim > 14 years or > 30Kg 800mg sulfamethoxazole / 160mg trimethoprim Source: WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. Page 59 SOP 10: TB-ART co-treatment regimens Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To provide TB-HIV co-infected patients with ART according to national guidelines, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management TB-HIV specialist Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB and HIV registers) as per national guidelines 2. CTX, ARV and TB medications 3. Laboratory test referral request form if required Procedure 10.1 Provide treatment for adults and adolescents If the decision is made to start co-treatment regimen (TB medications and ART), determine a safe plan and address and treat opportunistic infections, mental health issues, alcohol and substance use using facility protocols, before starting ART. Ensure that patient has been prescribed and is taking CTX (SOP 9). If the TB-HIV co-infected person has started TB treatment but is not yet on ART, initiate ART when patient is clinically stable on TB treatment, the following timeframes are presented as guidelines: If CD4 is <50, initiate ART within 2 weeks of beginning TB treatment; If CD4 is unknown but patient has signs or symptoms of immune suppression, initiate ART within 2 weeks of beginning TB treatment; If CD4 is > 50 and patient has no signs or symptoms of immune suppression, begin ART 4–8 weeks after initiating TB treatment. If the TB-HIV co-infected person has started TB treatment and is already on ART, continue ART: Consult immediately with the ART provider for a co-treatment plan if facility Page 60 physician is not an ART provider; Review the ARV regimen, evaluate the need for adjustment, checking drug-drug interactions with anti-TB medications (e.g. substituting NVP with EFV); Adapt the TB regimen to the ART regimen according to national guideline; Rule out ART failure, if PTB developed within 6 months of ART (without other clinical and immunological evidence of disease progression); Consider the possibility of ART failure if EPTB develops ≥ 6 months after ART initiation; tuberculosis lymphadenitis (TBLN or simple lymph node TB) or uncomplicated pleural disease may be less significant than disseminated TB. 10.2 Provide treatment for infants and children (Tables 10, 11, 12 13) If the TB-HIV co-infected infant or child has started TB treatment but is not yet on ART, initiate 2–4 weeks after starting TB treatment: In countries where universal ART is not yet feasible for TB-HIV co-infected patients, CD4 count and percentage measurements may be used to guide decision-making. If the TB-HIV co-infected pediatric patient has started TB treatment and is already on ART, continue ART. Consult immediately with the ART provider for a cotreatment plan if facility physician is not the ART provider. Review the ARV regimen, evaluate the need for adjustment, checking drug-drug interactions with anti-TB medications; Adapt the TB regimen to the ART regimen, as needed; If the TB diagnosis suggests first-line regimen treatment failure, check the %CD4 and, where possible, HIV viral load; If first-line regimen treatment failure is confirmed, then switch to a second-line regimen. Consult with a TB-HIV specialist to construct a second-line ART regimen; If the child is on a second-line ART regimen, consult with a TB-HIV specialist to construct a third-line ART regimen. 10.3 Counsel all clients (or their caregivers) on IRIS (Table 1414) Discuss with the patient, immune reconstitution syndrome (IRIS): IRIS is more common in co-infected patients with advanced immune suppression and disseminated TB; IRIS can occur 2 weeks to several months after initiation of anti-TB and ART; Symptoms of IRIS include: high fever, worsening cough, lymphadenopathy, rash repeat or worsening of disease symptoms experienced in the past, change in Page 61 mental status (signs of expanding central nervous system lesions); Symptoms usually are self-limiting and last 10-40 days, though some symptoms may be severe; The patient experiencing IRIS must report to the health facility as soon as symptoms occur; The patient should continue prescribed medications even if he or she feels treatment is failing. Tell the patient and family that: Signs or symptoms of IRIS indicate that the immune system is recovering or awakening; previously dormant infections are now recognized by the body’s recovering immune system; IRIS does not indicate a failing of ART, but rather shows that ART is working and the body is now awake and fighting. Monitor and manage signs and symptoms of IRIS at each visit: Document the onset, duration, and severity of symptoms upon presentation; Monitor the patient closely (e.g., daily if hospitalization is required), and document their response to management and treatment in the medical record. 10.4 Provide additional care and support, schedule follow up and document Discuss the chosen co-treatment plan with the patient and treatment supporter, caregiver. Counsel on TB-ART adherence. Provide the patient with a leaflet or other take home materials specific to the patient’s TB-ART regimen. Provide referrals as indicated during the visit, whether internal or outside the facility: Specialized care (cardiology, gynecology…), peer group support, home-based care. Schedule regular clinical and adherence visits: (see SOP 11) Record appointment in follow-up register. Document: Record all assessment, plan, prescribed medications, reviewed regimens, and discussions in TB Treatment Card, HIV Care/ART Card, and medical record; TB Treatment Card: highlight the start or modification of ART on the card so an opportunity to begin ART (if not already initiated) is not missed; Complete all relevant registers as per national guidelines. Complete paperwork for laboratory tests or other referrals, if applicable Dispense medications or ensure access to a pharmacy. Page 62 Table 10: Summary of eligibility criteria for ART for HIV-infected children by age Criteria to start ART < 12 months 12–35 mos. Clinical criteria based on WHO Staging Age 36–59 mos. 5 yrs. & above WHO Clinical Stage 4 Treat all Treat all WHO Clinical Stage 3 Treat all Treat all, but use CD4 count if available to decide on TB, LIP, OHL, thrombocytopaenia* WHO Clinical Stage 2 Treat all Guided by CD4 count (see below) WHO Clinical Stage 1 Treat all Guided by CD4 count (see below) Immunological criteria based on CD4 count or CD4 percentage CD4 count Treat all <750/mm3 <350/mm3 <350/mm3 CD4 percentage Treat all <20% <20% <15% *LIP: lymphoid interstitial pneumonitis; OHL: oral hairy leukoplakia Source: WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. Table 11: ART regimen choices in children who have started TB treatment Preferred first line ART regimen Regimen of 3 NRTI AZT + 3TC + ABC d4T + 3TC + ABC Alternative first line ART regimen Children over 3 years of age or > 10 Kg Regimen of 2 NRTI plus EFV: AZT + 3TC + EFV d4T + 3TC + EFV Children under 3 years of age or < 10 Kg and infants with prior exposure to NNRTI Regimen of 2NRTI plus LPV/ra or NVP: AZT + 3TC + LPV/r (or NVP) d4T + 3TC + LPV/r (or NVP) a. LPV/r needs additional boosting with ritonavir to reach mg equivalence (0.75ml ritonavir per ml LPV/r) Notes: 1. NVP should be started at full dosage in children receiving rifampicin. A lower lead-in dose of NVP should be avoided because this results in sub-therapeutic NVP levels. 2. The effects of rifampicin on ART metabolism lasts for 2 weeks after rifampicin is stopped. 3. When there is no PI available, and NVP is being used the drug should be dosed at the maximum which is based on 200mg/m2 rather than mg/kg. Source: WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. Page 63 Table 12: Recommended changes to ART management when commencing antiTB treatment in children Child over the age of 3 years or > 10 Kg and on 2NRTI plus NVP: Change NVP to EFV (and in specialist centres, consider increasing the dose of EFV) Continue with NVP but consider dosing at maximum (200mg/m2) Child under the age of 3 years or < 10 Kg and on 2NRTI plus NVP: Change NVP to LPV/r (and boost with added ritonavir to reach mg equivalence: 0.75ml ritonavir per ml LPV/r) Continue with NVP but consider dosing at maximum (200mg/m2) Source: WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. Table 13: Timing of ART initiation in relation to clinical stage of TB Clinical Stage of child with TB Timing of ART following initiation of TB treatment ETB (except TBLN) [WHO Stage 4] Start ART between 2 and 8 weeks after start of TB treatment CD4 measurements available: If CD4 counts and percentages are below threshold values shown in Table 10, start ART between 2 and 8 weeks after start of TB treatment. PTB and TBLN [WHO Stage 3] If CD4 counts and percentages are above threshold values shown in Table 10, consider delaying ART until later or after end of TB treatment provided there is an excellent response to Tb treatment. No CD4 measurements available: Start ART between 2 and 8 weeks after start of TB treatment. However, if there is an excellent clinical response to TB treatment, ART can be delayed until end of TB treatment. Source: WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. Page 64 Table 14: Common side effects in patients on TB-ART co-treatment and recommended responses Signs or symptoms: Response Anorexia, nausea, abdominal pain Take drugs with food (except for DDI or IDV). If on AZT, reassure that this is, usually self-limited. Treat symptomatically. If on INH, give it at bedtime. Joint pains Give aspirin, paracetamol, or nonsteroidal anti-inflammatory drugs. Burning sensation in feet Potential added toxicity if INH added to DDI or stavudine. Give pyridoxine 100 mg daily. If no response use amitryptiline (see p. 82, IMAI Acute Care) or call for advice. Orange/red urine Reassure patient that this is expected (with rifampicin). Headache Give paracetamol, aspirin or NSAID. Assess for meningitis (see IMAI Acute Care). In on AZT or EFV, reassure that this is common and usually self-limited. If persists more than 2 weeks or worsens, call for advice or refer. DiarrheaDiarrhea Re-hydrate. Follow diarrhea guidelines in IMAI Acute Care. Reassure patient that if due to ARV will improve in a few weeks. Follow-up in 2 weeks. If not improved, call for advice or refer. Fatigue Consider anemia especially if on AZT. Check hemoglobin. Fatigue commonly last 4 to 6 weeks especially when starting AZT. If severe or longer than this, call for advice or refer. Anxiety, nightmares This may be due to efairenz. Give at night; counsel and support (usually lasts<3 weeks). Call for advice or refer if severe depression or suicidal or psychosis. Initial difficult time can be managed with amitryptiline at night. Blue/black nails Reassure. It is normal with AZT. Changes in fat distribution Discuss carefully with your patient — can she/he accept it? Itching of skin, skin rash If generalized or peeling, stop TB and ART drugs and refer. If on nevirapine or abacavir, assess carefully. Is it dry or wet lesion? Call for advice. Deafness (confirm that this is not due to ear wax) Stop TB drugs and refer. Dizziness, lack of balance Stop TB drugs and refer. Jaundice (yellow skin or eyes) Send for ALT test and stop TB and ART drugs. Call for advice or refer. Vomiting repeatedly Check for common causes of vomiting (see IMAI Acute Care). Stop TB and ART drugs and call for advice or refer. Difficulty with vision Stop TB drugs and refer. Page 65 Psychosis, depression Fever Yellow eyes (jaundice) Abdominal or flank pain Pallor: anemia Cough or difficult breathing Lymphadenopathy Call for advice or refer if severe depression or suicidal or psychosis. Initial difficult time can be managed with amitriptyline at bedtime. Check for common causes of fever (see IMAI Acute Care). This could be a side effect, an opportunistic infection or other new infection or immune reconstitution syndrome. Call for advice or refer. Stop TB and ART drugs. Call for advice or refer. (abdominal pain may be pancreatitis from DDI or d4T). Stop TB and ART drugs and check ALT if available. Call for advice or refer. If possible measure hemoglobin and exclude opportunistic infections. Refer/consult (and stop AZT/substituted4T) if severe pallor or symptoms of anemia or very low hemoglobin (<8 g/dL; <7 g/dL in pregnant women). This could be immune reconstitution syndrome or an opportunistic infection (see IMAI Acute Care). Call for advice. This could be immune reconstitution syndrome. Call for advice. Source: WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI). Page 66 SOP 11: TB-HIV Treatment monitoring Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To use laboratory data alongside clinical assessment to determine patient’s response to TB treatment, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Laboratory technician Treatment monitor Others as needed Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. TB treatment referral/transfer form (Appendix 3), TB and HIV Medication Adherence Monitoring Record, any other forms required by site protocol or national guidelines 3. Equipment/supplies: a. Stethoscope b. Scale c. Blood pressure cuff d. Thermometer 4. Visual acuity chart 5. Request for Sputum Smear Microscopy Examination Form (Appendix 10), Request for Sputum Smear Microscopy and any other laboratory forms 6. Culture 7. Drug susceptibility test Page 67 Procedure 11.1 Schedule regular clinical and adherence visits during the TB treatment period If patient is hospitalized: Assess and monitor the patient daily; Provide DOT; Order labs as indicated by acute clinical status and per facility protocol; Discharge the co-infected patient as soon as clinically stable, and move to the outpatient monitoring schedule. If an outpatient, schedule clinical exams: Weekly, including treatment follow-up and intensive adherence review (SOP 13), for the first 4 weeks of the intensive phase, then; Every 2 weeks until the intensive phase is completed, then; Monthly during the continuation phase. If a co-infected patient from another site (e.g., community-based clinic) with ETB or MDR or XDR-TB disease is referred/transferred to your facility: Register the patient in your clinic with all the needed forms; Schedule regular visits according to the patient’s diagnosis, clinical status, and where the patient is in the TB treatment plan; Maintain contact with the referring clinician regarding patient management; Develop a care plan with the referring clinician; Facilitate communication and referrals between the 2 sites. Over time, the patient may develop needs that can be met at the referring site, such as DOT and primary care management. 11.2 Provide a comprehensive clinical assessment of the co-infected patient at each acute and scheduled appointment Schedule the patient for laboratory investigations a week in advance from the clinical appointment to allow time for receipt and review of laboratory results. Measure and document (nurse): Vital signs, weight, BMI in children; Nutritional status; Visual acuity and color vision, if on ethambutol. Monitor (see SOP 13) and track adherence on Tuberculosis Care Card and HIV Care/ART Card. Assess and document complete clinical status (physician or clinical Page 68 officer), including: Clinical response to treatment; Signs/symptoms of IRIS or hepatitis; TB- and ART-related side effects (SOP 14), signs/symptoms of hepatitis; Common HIV-related infections such as pneumonia, diarrhea, fungal infections; Treat as indicated in SOPs for HIV clinical care and treatment. Order the tests and studies required/indicated in Section 11.3, below (physician or clinical officer) and If patient develops new signs or symptoms, assess, classify, and treat according to site protocol. Reinforce the importance of clinic visits, laboratory requests, and medication adherence at each interaction. Coordinate referral to laboratory (if offsite); track receipt of results (nurse and laboratory technician). 11.3 Use laboratory data alongside clinical assessment to determine patient’s response to TB treatment. In sputum smear-positive PTB HIV-infected patients: If on an 8-month regimen, collect sputum samples: At the end of the initial phase (month 2); In the continuation phase (month 5); During the last month of treatment (month 8). If on a 6-month regimen, collect sputum samples: At the end of the initial phase (month 2); In the continuation phase (month 5); During the last month of treatment (month 6). Complete Request for Sputum Smear Microscopy Examination Form: Send samples to the laboratory for smear microscopy; The laboratory technician records the exam results on the Sputum Examination Request Form and returns it to the requesting site. If patient is sputum smear-positive after the intensive phase, send sputum for drug resistance testing to rule out MDR-TB; If indicated, repeat CXR and review for changes or signs of improvement. Followup CXRs are not routinely recommended although country guidelines may vary on this; Page 69 Record all results on the patient’s TB Treatment Card, and indicates dates of: Sputum (if positive, record the highest grading) Weight Clinical follow-up For previously-treated pulmonary sputum smear-positive patients, collect sputum for smear exam: At the end of the initial phase of treatment (the end of month 3); During the second month after starting the continuation phase; At the end of treatment. In HIV-infected sputum smear-negative PTB patients: Collect sputum at the end of month 2 (2 specimens), in order to: Monitor disease progress due to non-adherence, and Check for an error at the time of the initial diagnosis (e.g., true sputum smearpositive misdiagnosed as smear-negative), and Check for drug resistance. Where possible, mycobacterial culture may also be used to monitor progress for sputum smear-negative PTB patients; Otherwise, clinical monitoring is the primary measure of a patient’s progress. Use body weight as a progress indicator. In HIV-infected sputum smear negative ETB patients, clinical monitoring is the primary measure of a patient’s progress. One will also use body weight as a progress indicator. In HIV-infected patients with any active TB diagnosis on anti-TB medications and ART, collect blood specimens to monitor for adverse reactions and toxicity: Acutely, when clinically indicated (e.g., change in pallor, jaundice); Monthly, check FBC and LFTs until normal on 2 consecutive occasions; Every 6 months, check CD4 count (and %, if child) and viral load. 11.4 Modify or change TB treatment doses or drugs Always refer to national guideline and facility protocol. In infants and children, adjust TB (and ARV) dosages according to weight gained since the last visit. In smear-positive PTB cases on Category I treatment: If both smear specimens are negative: Page 70 Discuss sputum smear-negative results with the patient; Document plan on the TB Treatment Card; Begin and then complete the continuation phase. If sputum smear returns positive at month 2: Extend the initial treatment phase by 1 extra month; Review the patient’s medications and treatment schedule: » If the treatment has not been regular, discuss with the patient the need to take the treatment exactly as prescribed; » Consider stronger follow-up DOT strategies with the nurse, treatment supporter, and patient. Check smear at the end of month 3 to evaluate smear conversion ; After the third month of the initial phase regimen, start the full continuation phase; Check sputum again in month 5. Consider sending specimen for TB culture to confirm treatment failure; If month 5 sputum returns positive, document the patient as a treatment failure: » Close the TB Treatment Card (outcome = treatment failure); » Open a new TB Treatment Card (patient type = treatment after failure); » Begin Category II retreatment; if considering Category IV regimen, refer to (SOP 16) for MDR-TB diagnosis protocol and prescribe the regimen according to national guidelines and NTP; » Send sputum to laboratory for culture and drug sensitivity; use Request for Sputum Smear Microscopy, Culture, Drug Susceptibility Test. In previously-treated pulmonary sputum smear-positive patients: If sputum smear-positive at the end of month 3, extend by 1 month, the initial phase with 4 drugs; Check sputum smear at the end of month 4; If sputum-positive at month 4, send sputum to the lab for culture and sensitivity testing; Start patient on the continuation phase; If culture and sensitivity show resistance to 2 of the 3 drugs in the continuation phase, consult a TB-HIV specialist and consider using reserve anti-TB drugs; If culture and sensitivity testing is unavailable, continue patient treatment until the end of the re-treatment regimen; If sputum-positive at the end of month 5, document and inform the patient of Page 71 retreatment failure; Consider a drug resistant regimen (SOP 16). For new smear-negative pulmonary cases (Category III): If patient has 2 positive smears at the end of month 2, start a full course of Category II treatment: Record the outcome as “failure”; Re-register the patient. If sputum smears remain negative at the end of the initial treatment phase, open a new TB Treatment Card (patient type = other); Begin Category II treatment. Adjust the dose or change drug based on clinical assessment of severe kidney and liver response to TB medications, confirmed by laboratory investigations: Review the case in a multidisciplinary team meeting; Consult with a TB-HIV specialist, nephrologist, or gastrointestinal specialist as needed. All cases indicating TB treatment or ART failure require evaluation by a TB-HIV specialist; Notify NTP of any treatment changes based on a full, comprehensive assessment; Schedule follow-up and record appointment in follow-up register; Document: Record all findings, changes to treatment dose or regimen, prescribed medications and discussions in TB Treatment Card, HIV Care/ART Card, and medical record; Complete all relevant registers as per national guidelines; Complete paperwork for laboratory tests or other referrals, if applicable. Page 72 SOP 12: Isoniazid Preventive Therapy Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To provide INH preventive therapy according to national guidelines, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. INH drugs Procedure 12.1 Symptom Screen HIV-infected patients for active TB disease and eligibility for INH preventive therapy at every clinical encounter Rule out active TB disease (SOP 6 and 7): Children living with HIV who are more than 12 months of age who have any of the symptoms listed in Figure 1, SOP 6 (poor weight gain, fever, current cough (any duration) or contact history with a TB case) should be evaluated for TB and other conditions. If the evaluation shows no TB, determine INH preventive therapy eligibility (see 12.2, below). Children living with HIV who are less than 12 months of age, who have had contact history with a TB case should be evaluated for TB. If the evaluation shows no TB, determine INH preventive therapy eligibility (see 12.2, below). Adults living with HIV who have any of the symptoms listed in Figure 2, SOP 6 (current cough, fever, weight loss, night sweats) should be evaluated for TB. If the evaluation shows no TB, determine INH preventive therapy eligibility (see 12.2, below). If TB is suspected: Initiate IC measures (SOP 5); Begin a thorough, immediate evaluation (e.g., CXR). Ask patients with active TB to bring household contacts to the clinic for screening, Page 73 including: Any HIV-positive person in the household; P(s)Partner(s) or spouse; Children < 5 years old; People in the household with a cough lasting more than 2 or 3 weeks; Pregnant women. 12.2 Determine INH preventive therapy eligibility Adults and adolescents living with HIV who have an unknown or positive TST status and who are unlikely to have active TB should receive at least 6 months of INH preventive therapy. Give INH preventive therapy irrespective of the degree of immune suppression, whether or not the patient is taking ART, and whether or not the patient has previously been treated for TB or is pregnant. Children living with HIV who have any one of the following symptoms – poor weight gain, fever, current cough or contact history with a TB case – may have TB and should be evaluated for TB and other conditions. If the evaluation shows no TB, such children should be offered IPT regardless of their age. All infants and children should be given IPT for 6 months once active tuberculosis has been excluded. In high TB-HIV prevalence regions, all HIV-infected patients in whom active TB has been ruled out (symptom screen negative, see 12.1 above, OR laboratory/radiologic investigations negative) and who have no contraindications should be offered INH preventive therapy. Contraindications include the following: Excessive alcohol consumption; Chronic active hepatitis. 12.3 Prescribe INH preventive therapy Provide education to the patient about INH preventive therapy, including the purpose of medication, and the long-term nature of INH preventive therapy. Prescribe INH, the recommended drug for tuberculosis prevention, in children, adolescents, and adults, according to national guidelines and/or facility protocol: Pediatric dose: 10 mg/kg (maximum dose = 300 mg daily) for 6 months; Standard adult dose: 300 mg daily for 6–9 months; Treatment can be self-administered; DOT not required; INH is not contraindicated for pregnant patients. Discuss with patient the most common side effect of INH – jaundice, severe allergies, rash and peripheral neuropathies , presenting as a burning sensation in the feet: Page 74 Treat this in advance according to national guidelines; Review with the patient the need to stop INH and come to the facility immediately if major side effects occur, such as new itching of skin or skin rash, joint pain, yellowing of eyes or change in skin color, nausea, vomiting, abdominal pain, dark urine, light colored stools, confusion and convulsion. Review minor side effects; offer suggestions for treating in the home setting. Provide INH preventive therapy prescription and ensure pharmacy access throughout the duration of treatment. 12.4 Monitor INH preventive therapy Ensure monthly clinical monitoring while the patient is on INH preventive therapy. At each visit clinic staff assesses adherence to medication. Ask about side effects. Encourage the patient to immediately report any symptoms including jaundice, dark urine, nausea, vomiting, abdominal pain and fever. Ask about peripheral neuropathy: Patient is at increased risk of neuropathy if on d4T, too If peripheral neuropathy develops, first switch off dd4T and see if symptoms improve If peripheral neuropathy persists, increase pyridoxine to 100 mg daily Prescribe a 1-month supply of medication at each visit. Consider giving the patient an additional 2-week emergency supply to encourage adherence in case the patient must miss or defer a monthly appointment. Order and review laboratory investigations as indicated by clinical signs and symptoms. Discontinue INH if major drug side-effects persist in the absence of other causes. 12.5 Complete INH preventive therapy The duration of INH preventive therapy provision to any group will be delivered according to national guidelines. Once treatment is completed: Document evaluation of INH preventive therapy outcome (e.g., withdrawals, completion of therapy) in patient’s medical record, TB treatment card, TB register and HIV care card; Continue TB screening at every acute and scheduled clinical visit. After INH preventive therapy course is completed in children less than 2 years old: Check to see if the child has received a BCG immunization injection; Page 75 Only give the immunization once the child completes INH preventive therapy; Document immunization administration in the child’s vaccination record and medical chart. 12.6 At every visit: schedule follow up and document Schedule next monthly appointment and record appointment in follow-up register. Document: screening, results, findings, discussions, INH preventive therapy initiation date, and adherence in the patient’s medical record; Prepare an HIV Care/ART Card documenting: Diagnostic findings; Treatment initiation including INH preventive therapy; Baseline laboratory findings (e.g., LFTs, RFTs, FBC); Ongoing clinical and laboratory monitoring; Treatment discontinuation date and reason (i.e., due to adverse events or due to treatment completion). Prepare an HIV Care/ART Card if a household contact is HIV-positive and not enrolled in an HIV care and treatment program. If the HIV-infected household contact is already enrolled in another HIV program: Notify the program of the INH preventive therapy and consult with them regarding HIV care and treatment; Consider transferring care if concerned about treatment adherence. Complete all relevant registers as per national guidelines; Complete paperwork for laboratory tests or other referrals, if applicable. Page 76 SOP 13: Promoting and monitoring treatment adherence, directly observed therapy (DOT) Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To support and monitor TB treatment and ART, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Treatment supporter Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. TB and HIV Medication Adherence Monitoring Record, Adherence Monitoring Record 3. TB treatment referral/transfer form (Appendix 3), any other forms required by site protocol or national guidelines 4. Equipment/supplies: a. Information, education and communication materials, treatment aids (e.g., calendars, pillboxes) b. Job aids, e.g., flipcharts to help explain key concepts to patient c. Photos of patients with TB and HIV co-infection taken before and after completing TB treatment Procedure 13.1 Agree on DOT plan Assess each patient for risks of potential non-adherence: alcohol and drug use, pregnancy, mobility, or mental illness. Also, employment status, food security and transport to clinic (SOP 14). If a patient is hospitalized, DOT may be administered and monitored by the inpatient nurse as directed by the facility TBIC plan until the patient transfers to outpatient care. Page 77 If patient is treated as an outpatient, the nurse meets with the patient to discuss a medication adherence and clinic visit plan. Confirm DOT location: If outside the clinic site, such as in the home or workplace, a community-based TB treatment supporter can provide DOT; If at the site: » A site staff or volunteer will provide DOT; » If the patient is prescribed streptomycin, the patient needs to come to the site as a trained health worker needs to provide the sterile injection. Decide on and train the treatment supporter (SOP 17). Obtain patient consent for home visits. Discuss clinic visit plan: weekly to monthly clinic visits; more frequent if signs/symptoms or difficulties occur. If the patient refuses DOT: Discuss disclosure issues; help the patient move toward a disclosure plan that is acceptable; Discuss options; encourage adherence and the need to follow up; Create a patient-centered approach; begin developing a working relationship with the patient; Continue close clinical and adherence follow-up and psycho-social supportive care. 13.2 Review adherence Treatment supporter: Observe the patient taking the prescribed treatment (TB and ART, as needed) on a daily (or 2–3 times per week) basis. Document adherence on the TB Treatment Card; Visit the health site/facility on a monthly basis to collect the next month’s drug supply, review adherence, and to review problems with the nurse as needed. Nurse (serves as the team leader for DOT, delegates responsibility to TB educators and trained site staff for DOT-related activities): If the patient is on community-based DOT: Review the TB Treatment Card, which is kept by the treatment supporter, with the patient during his or her monthly assessment, and before seeing the physician/clinical officer. Transcribe the days on which the patient took the treatment onto the original TB Page 78 Treatment Card kept at the site. Review patient’s adherence and troubleshoot any problems from the past month. Ask patient: » How often do you receive medicine from the treatment supporter? Do you receive medicine at the same time every day? » How often do you see the treatment supporter fill in the treatment card? What drugs do you receive from the treatment supporter? Determine whether the relationship between the treatment supporter and patient is positive and is working to the patient’s benefit: » How is your relationship with the treatment supporter? » Are you willing to receive medicine from the same treatment supporter until the treatment course is completed? Would you prefer to change treatment supporters? » If a change is requested, probe for reasons why the patient wants or needs to change treatment supporters. Continue to reinforce the patient’s role in self-management of the illness; Review the TB Treatment Card with the treatment supporter on a monthly basis when the treatment supporter collects the monthly drug supply; discuss any problems: » Record on the front of the TB Treatment Card the drugs provided to the supporter for the next month, and the date provided. Ask about any travel plans and alert the physician/clinical officer to the patient’s travel needs. If the patient takes site-based DOT: Observe the patient taking the medication; Document adherence on the TB Card, TB/ART Card and the medical record (per site protocol). Physician/clinical officer: Review the nurse’s documentation and discuss the adherence plan with the patient and the treatment supporter, if available; Provide the prescription for the next month’s TB (and ART, if prescribed) drug supply; Ask about any future travel plans. Work with team to ensure that treatment continues. 13.3 Role of the treatment supporter or site staff providing DOT Page 79 Meet with the patient to arrange a specific time and place to give/take medication(s). (If a community-based treatment supporter) Arrive at the designated place on time and does not make the patient wait. Ask the patient about possible side effects. Minor side effects: if patient reports nausea, lack of appetite, stomach pain or discomfort — encourage the patient to eat a small snack with the tablets; for patients who do not have food to eat, refer to an non-governmental organization or welfare service for food support: Refer the patient for an appointment with the nurse, physician or clinical officer if nausea continues; Document referral on the treatment card; If available, offer the patient food by prescription. If the patient reports that their sweat, tears or urine is orange/red, tell them this is a normal side effect; If the patient complains about joint pain or a burning sensation in the hands or feet, refer the patient to the site for the soonest appointment; Major side effects: if a patient reports itching of the skin, skin rash, hearing loss, deafness, new dizziness, jaundice, continued vomiting, vision changes, difficulty seeing — do not give TB medication. Immediately refer the patient to the health facility for evaluation by the physician or clinical officer. Review the patient’s medications: First, check to make sure the drugs are correct Next, watch the patient take and swallow all the drugs If needed, give the prescribed injection according to protocol Finally, document on the treatment card that the patient took the drugs Encourage the patient to continue the treatment exactly as prescribed. Praise the patient for completing doses, managing side effects, and keeping scheduled appointments. If the patient misses 1 dose: If a patient takes medication at home or work: Return the next day and ask the reason for the missed dose; problem solve so doses are not missed again in the future; Give the next scheduled dose; Extend the treatment by the missed dose day; If unable to find the patient or the patient refuses the medication, contact the site the same day. Page 80 If a patient takes medication at the site: Visit the patient’s home within 24 hours; Ask the reason for the missed dose; Give the next scheduled dose; If unable to find the patient or the patient refuses the medication, make an urgent appointment for the patient in the clinic to see the physician or clinical officer for further support and evaluation. If the treatment supporter or patient travels out of town for a few days: Inform each other of travel plans at least 1 week in advance; The treatment supporter makes arrangements for the patient to have exactly enough drugs to self-administer medication for only 1 week; If travel will be longer than 1 week, meet with the clinic team to determine a plan: Reinforce with the patient that treatment cannot stop or pause once started but needs to continue until the end; Perhaps consider transferring the patient to a site near the patient’s destination if travel will be longer than a few weeks. Be aware of the patient’s appointments and laboratory schedule. The patient’s clinic appointments should be at least monthly, and more frequent during the initiation phase and depending on other clinical issues or emergent needs; If a pulmonary TB patient, the patient will need to go to the site, lab, or facility (depending on site resources) for repeat sputum smear exams. These are usually scheduled 3 times: at end of the initial treatment phase, after 5 months of treatment, and during the last month of treatment; Make sure the patient goes to the site or laboratory, per site standard, to have labs checked (e.g., hematology, LFTs or sputum collection) at least a week before the clinic appointment, so that results will be available for physician or clinical officer evaluation. 13.4 Offer DOT for both TB treatment and ART Maintain DOT as long as resources allow, DOT is considered ideal to maximize adherence to any drug regimen, including ART. DOT may not be sustainable after the end of TB treatment for lifelong ART. Develop a flexible patient-specific approach for maximum adherence The treatment supporter can observe the patient receiving ART at different intervals, depending on need: Page 81 Daily or twice daily Several times a week Once a week Combine the daily observation of TB treatment with 1 of the ART doses, preferably the morning dose. Remind the patient about the next (unobserved) dose(s) of ART and help, as able, to ensure adherence with ART: Lay out the pills; Discuss ways to help the patient remember the next dose(s); The next day, check whether the patient took the other ART dose(s). 13.5 For patients who travel, arrange continued TB/ART treatment Review travel plans at every clinic visit. If a patient plans to travel out of the area, or will be unable to have treatment directly observed for 1 or more days: Give patient careful instructions and drugs for self-medication Instruct the patient to: » Swallow the drugs at the same time each day » Swallow pills with water » Swallow all of the TB and ART drugs (for the day) at a time Point out the number and color of the drugs in each day’s packet Provide both oral and written instructions. If patient does not read, consider arranging for a substitute treatment supporter (either community- or facilitybased) who can provide DOT support at the patient’s travel destination. Ask checking questions to make sure that the patient understands when and how to take the drugs; If necessary, provide a drug supply that lasts up to 2 weeks; If the patient’s drugs are not pre-packaged, prepare a separate packet of drugs for each day the patient will be gone; On the patient’s TB Treatment Card, mark a tick when you observe treatment draw a line through the days on which the patient will self-administer the drugs. 13.6 If a patient misses doses or appointments, schedule a home visit to discuss barriers to care and treatment (nurse-led) Arrange to have the treatment supporter present during the conversation with the Page 82 patient in the home setting. Ask about adherence in a non-judgmental way (e.g., avoid “why” questions): How do you usually take your medications? When do you usually take your medications? What happened that you missed your appointment? What happened that you missed taking your medication? Listen to the patient’s responses for barriers to treatment adherence, examples of such barriers include (see Table 15): Attitudes of the health facility staff who observe treatment Waiting time at the health facility Transportation Work or family commitments Side effects of treatment Other health problems Work with the patient, treatment supporter, and family/friends/household members to solve specific problems to long term care or any other concern. Work with the patient, treatment supporter, and family/friends/household members to motivate the patient during the conversation. Use correct statements to provide hope about taking prescribed treatment (SOP 18, Table 27): Show photos of patients with TB and HIV co-infection, before and after TB treatment. Ensure that confidentiality is maintained (e.g., cover the face of patients in the photos if using photos of local patients); Explain that the photos illustrate that despite HIV infection, TB is curable and these patients, despite difficulties, were cured. Give the patient the missed dose and explain that past missed doses will continue to be given 1 day at a time until all pills are taken as prescribed. Instruct the patient and treatment supporter to not give an extra dose on any day. Record a zero (0) on the TB Treatment Card for each day of missed treatment. Add a comment on the action taken during the home visit, e.g., “Home visit; treatment resumed.” 13.7 If a patient misses doses or appointments for longer than a month, attempt to find the patient First, trace the patient and find their location using family members, friends, or other Page 83 community resources. Once the patient is traced and contacted, immediately meet with the patient in the clinic, if possible. Ensure that the patient’s health status is stable, then arrange with the physician or clinical officer to collect 2 or 3 sputum samples. Discuss the reason the patient stopped treatment. As a team, determine the cause of the treatment interruption: Work together with the patient to find ways to prevent future treatment interruptions; If the patient plans to re-locate for a prolonged period of time, use SOP 2 to guide the transfer of the patient to another site or facility to continue treatment. If treatment interruption has been for 1–2 months: Restart (physician or clinical officer) the patient’s TB treatment and provide prescriptions for other medications (e.g., prophylaxis medications), as needed, while waiting for sputum results; Prolong the TB treatment to make up for missed doses. If the treatment interruption has been 2 months or longer, the patient is considered a treatment defaulter: Do not restart treatment; Wait for return of sputum results to restart treatment regimen. Refer to Table 16 to guide TB treatment actions based on sputum results. Discuss the new (or continued) treatment plan with the patient and treatment supporter. 13.8 At every visit: schedule follow up and document 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: Record the treatment plan and actions taken to support the patient in the TB Treatment Card, HIV Care/ART Card, and medical record; Complete all relevant registers (e.g., TB register, Adherence Monitoring Record) as per national guidelines. Page 84 Table 15: Possible causes of missing doses and possible solutions Examples of possible causes of Possible solutions: missed doses: Coming to the health facility is inconvenient. Identify a convenient community TB and ART treatment supporter. Patient dislikes coming to the health facility because of the long queue. Make arrangements so that TB-HIV patients do not have to wait in a queue. For example, let them enter through a back or side door. Supervisor at work kept the patient late. Offer to talk with the supervisor and explain the importance of the treatment, or Identify a community TB and ART treatment supporter at work. Patient had troublesome sideeffects. Give appropriate advice or remedies for sideeffects, or refer the patient if necessary (see Table 14). Patient had difficulty swallowing because of pain (this could be oral thrush). Use IMAI Acute Care or IMAI Palliative Care to classify and provide treatment or to refer patient as necessary. Suggest that a family member or neighbor watch the children. Remind family members/neighbors Patient cannot leave small that the patient must continue treatment to protect children at home and is tired of their health, particularly the health of the children. If bringing them to the health facility. possible, identify a community TB and ART treatment supporter closer to the patient’s home. Source: WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI), pp 63 and 71. Page 85 Table 16: TB Treatment interruption guidelines Interruption for less than 1 month Trace patient Solve the cause of interruption Continue TB treatment and prolong it to compensate for missed doses Interruption for 1 up to 2 months of TB treatment First: Then, take action based on results of sputum examination: Trace patient Solve the cause of interruption If all smears are negative, or patient has extrapulmonary TB Continue treatment and prolong it to compensate for missed doses Collect 3 sputum samples If 1 or more smears positive, and Patient has been treated for less than 5 months Continue treatment and prolong it to compensate for missed doses Patient has been treated for 5 months or more If patient was on: While waiting for results, continue treatment Cat I — Start Cat II Cat II — Refer (may evolve to chronic) Interruption for 2 months or more (default) First: Collect 3 sputum samples Solve the cause of interruption, if possible Do not give treatment while waiting for results Then, take action based on results of sputum examination: If all smears are Clinician decides on individual basis negative, or whether to restart or continue treatment, patient has or no further treatment extrapulmonary TB If 1 or more smears positive, and Patient was previously on Cat I Start Cat II Patient was previously on Cat II Refer (may evolve to chronic) Source: WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI). Page 86 SOP 14: Monitoring and managing TB treatment and ART Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To monitor for and manage side effects of anti-TB treatment, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Laboratory technician Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. TB AND HIV Medication Adherence Monitoring Record 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Visual acuity chart Procedure 14.1 Monitor for and address side effects of medications at every clinic appointment Infants and children on anti-TB treatment: If present, document the side effect, its onset, duration, severity, treatment and response in the medical record. Manage immediately. Children tend to have fewer adverse reactions than adults to anti-TB treatment (Table 17). Report adverse events to the NTP. For a child not responding to TB treatment, evaluate the child for: Drug-resistant TB (SOP 16); Page 87 An unusual complication of pulmonary TB; Other causes of HIV-related lung disease per facility HIV care and treatment SOPs; Problems with treatment adherence (SOP 13); Viral failure per facility HIV care and treatment SOPs. Adults and adolescents on anti-TB treatment: For minor side effects (see Table 18): Continue anti-TB drugs; Check drug doses; Encourage the patient to report all minor symptoms during monthly visits, but to monitor and manage them at home; Review symptoms each month; Document response to symptomatic management in the patient’s medical record. For major side effects: (see Table 19) Stop the offending anti-TB drug; Evaluate the onset, duration and severity of each specific symptom; Determine if presentation or treatment requirements indicate hospitalization; Consult with the medical team and TB-HIV specialist as needed; Report adverse events to the NTP and document in the patient’s medical record; Continue close follow-up. Monitor all HIV-infected patients taking both TB treatment and ART (whether infant, child, adolescent or adult), see Table 20: Evaluate the onset, duration, and severity of each specific symptom; Determine if presentation or treatment requirements indicate hospitalization; Try to determine the offending agent: anti-TB medication or ART component. Consult with the medical team and TB-HIV specialist as needed. Refer to facility protocol for comprehensive symptomatic management of minor and moderate medication-related symptoms. Meet with the clinical team or TB-HIV specialist to determine further TB and ART treatment. 14.2 Consider IRIS or ART failure if there is no improvement on TB treatment and ART Consider the possibility of IRIS or ART failure if a TB-HIV patient on ART does not Page 88 gain weight or develops new HIV-related diseases (WHO clinical stage 3 or 4): Treat acute symptoms; Order TB and HIV resistance testing, as indicated; Reassure the patient; If IRIS is identified in the first 6 months of starting ART, do not presume treatment failure and follow procedures according to national guideline; If ART failure is suspected, discuss case with the multidisciplinary team and TBHIV specialist to reconstruct an ART regimen or start a salvage regimen. 14.3 At every visit: schedule follow up and document 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: Record actions taken to support the patient in the TB Treatment Card, HIV Care/ART Card, and medical record; Complete all relevant registers as per national guidelines. Page 89 Table 17: Symptoms related to TB drug toxicity in children Sign/symptom Associated TB drug Management Hepatotoxicity Isoniazid Liver tenderness Pyrazinamide Immediately stop all hepatotoxic medications. Hepatomegaly Rifampcin Screen for other causes of hepatitis. Jaundice Do not reintroduce hepatotoxic drugs until liver function normalizes. Serum liver enzymes > 5 times the normal value Consult an expert in managing drug induced hepatotoxicity in further patient management. If severe TB form requires continued TB treatment, introduce non‐hepatotoxic anti‐TB drug (e.g., ethambutol, aminoglycosie and fluoroquinolones). Offer supplemental pyridoxine 5‐10 mg/day. Peripheal neuropathy Isoniazid Source: FHI (2009). Collaborative TB-HIV Services: Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites. P 125 Table 18: Minor symptoms associated with anti-TB treatment in adults Sign/symptom Associated TB drug Management Pyrazinamide Take medicine with a small meal. Rifampicin Give drug at bedtime. Isoniazid Loss of appetite, nausea, stomach pain Joint pain Pyrazinamide Give aspirin. Burning pain in hands/feet Isoniazid Give pyridoxine 100 mg daily. Consider prescribing amitryptiline. Orange/red urine Reassure patient. Explain that this is a normal finding when taking rifampicin. Rifampicin Source: FHI (2009). Collaborative TB-HIV Services: Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites. Page 90 Table 19: Major side effects of anti-TB drugs Symptom Main anti-TB drug involved Management Streptomycin Stop TB drugs. Isoniazid Start antihistamines; observe closely. Rifampicin Pyrazinamide Reintroduce anti‐TB medications after the rash resolves, starting with the least offending agent (INH) at a small dose, gradually increasing the dose over 3 days. Repeat the procedure adding 1 drug at a time. If the drug responsible is pyrazinamide, or streptomycin, resume treatment without the offending drug; if possible, replace the offending drug and consider extending the treatment regimen. Skin rash Hearing loss, deafness (after TB drug initiation; no wax on auroscopy) Streptomycin Stop streptomycin; use ethambutol. Dizziness, balance loss, vertigo, nystagmus Streptomycin Stop streptomycin; use ethambutol. Jaundice (other causes excluded) Isoniazid Stop anti‐TB drugs. Pyrazinamide Wait until LFTs return to normal. Hepatitis Rifampcin If LFTs are unavailable, wait 2 weeks after jaundice disappears, then restart TB treatment. Reintroduce anti‐TB drugs 1 at a time. Avoid Z if hepatitis caused jaundice. Suggested regimen: 2 SHE/10 HE Option: Treat with S and E and then the usual TB treatment after hepatitis resolves. Page 91 Confusion (suspect drug‐induced acute liver failure if jaundice present) Visual changes (oother causes excluded) Shock, purpura, acute renal failure Most anti‐TB drugs Stop anti‐TB drugs. Order urgent live function tests and prothrombin time. Ethambutol Stop ethambutol Rifampicin Stop rifampicin. Isoniazid (H); Rifampicin (R); Pyrazinamide (Z); Ethambutol (E); Streptomycin (S) Source: FHI (2009). Collaborative TB-HIV Services: Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites. P 204 Page 92 Table 20: Adverse reactions to ARVs and their management Main ARV drug involved Main anti-TB drug involved Peripheral neuropathy (early or late side effect) Stavudine Isoniazid Didanosine Cycloserine Hepatitis (usually early side effect) Nevirapine Pyrazinamide PI Rifampicin Isoniazid Ethionamide Adverse reaction Management Pyridoxine given as preventive therapy and treatment for INH toxicity. STOP all drugs; once resolved, restart with TB treatment. Gastrointestinal dysfunction (diarrhea, abdominal pain, early or late side effect) All All Symptomatic Skin rash (usually early side effect) Nevirapine Rifampicin Efavirenz Isoniazid Abacavir Pyrazinamide Cycloserine Antihistamines if mild; if severe, STOP all drugs; once resolved, restart with TB treatmenttreatment. Isoniazid (H) Cycloserine Rifampicin Central nervous system dysfunction (early or late side effect) Anemia (usually early side effect) Efavirenz Zidovudine Pyridoxine given as preventive therapy and treatment for INH toxicity. Change from zidovudine to stavudine. Source: WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. Page 93 SOP 15: Determining TB treatment outcome Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To determine and record outcome of anti-TB treatment, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Supplies 1. TB Treatment Card (Appendix 1), HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB and HIV registers) as per national guidelines 2. TB AND HIV Medication Adherence Monitoring Record; Adherence Monitoring Record 3. Laboratory investigation results Procedure Conduct a final follow-up medication review (nurse-led): Review the patient’s TB treatment monitoring schedule at the visit corresponding with the last scheduled TB treatment dose; ask the patient If all pills were taken; Review the TB Treatment Card to ensure that documentation shows all medications doses were taken by the patient; Confirm with the treatment supporter that all doses were completed and if not, provide adherence counseling (as per site protocol); Document findings in the medical chart and on the TB Treatment Card. Review follow-up laboratory investigations (nurse-led): Prepare the medical record to include the current laboratory investigations for physician or clinical officer review, and document findings from the medical record: Sputum results (microscopy and if available, mycobacterial culture); CXR (if pulmonary TB); Other test as needed or ordered. Provide the medical record and lab results to the physician or clinical officer; physician or clinical officer reviews the laboratory results and decides upon a Page 94 treatment outcome diagnosis. Decide on the treatment outcome and record on medical record, TB Treatment Card, and TB register (led by physician or clinical officer): Using the patient and laboratory register, along with adherence data, examine the patient and conduct a confirmatory interview about medication adherence and symptoms; Determine a treatment outcome and document on the back of the TB Treatment Card alongside the date the outcome determination was made (ideally, the last day of treatment), according to the original diagnosis. A listing of treatment outcomes and their definitions is included in Table 21, the listing of possible treatment outcomes is in Table 22; MDR-TB: Possible treatment outcomes for MDR-TB (SOP 16) are also listed in Table 21. Use the laboratory smear and culture as a monitoring tool. Assign Category IV to patient who has experienced MDR-TB as the first outcome for the treatment prescribed; Clarify if treatment stopped due to completion (or death), or restarted, and the date. If restarted, the nurse begins a new treatment card. If treatment is completed, congratulate the patient and the treatment supporter. Educate the patient about continuing follow-up for HIV/ART care and treatment, and the need for continued disease prevention precautions. Notify national TB program per protocol. Report outcome by HIV co-infection status. Continue intensified support and determine next steps with the patient and TB-HIV specialist if patient fails treatment. Ensure the continuation of HIV treatment and care, regardless of outcome. Offer INH preventive therapy to HIV-infected patients after they successfully complete TB treatment. Page 95 Table 21: Definitions of treatment outcomesa Definition for MDR-TB Outcome Definition Cure A patient whose sputum smear A patient who: or culture was positive at the Completed treatment according to beginning of the treatment but program protocol. who was smear- or culture Had at least 5 consecutive negative negative in the last month of cultures, from samples collected at treatment and on at least 1 least 30 days apart, in the final 12 previous occasion. treatment months. If only 1 positive culture is reported during that time, with no concomitant clinical evidence of deterioration, patient may still be considered cured, but requires the positive culture to be followed by a minimum of 3 consecutive negative cultures taken at least 30 days apart. Treatment completed A patient who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least 1 previous occasionb A patient who: A patient whose sputum smear or culture is positive at 5 months or later during treatment. Also included in this definition are patients found to harbor a multidrug-resistant (MDR) strain at any point of time during the treatment, whether they are smearnegative or -positive. A patient is considered to have failed treatment: Died A patient who dies for any reason during the course of treatment. A patient who dies of any cause during the course of M(X)DR-TB treatment. Default A patient whose treatment was A patient whose treatment was Treatment failure Completed treatment according to program protocol but does not meet the definition for cure. Lacks bacteriological results; for example, fewer than 5 cultures were performed in the final 12 months of treatment. If 2 or more of the 5 cultures recorded in the final 12 months of treatment are positive, or If any 1 of the final 3 cultures is positive If a clinical decision terminated treatment early because of poor clinical or radiological response, or adverse events Page 96 interrupted for 2 or more consecutive months. interrupted for 2 or more consecutive months for any reason without medical approval. Transfer out A patient who has been transferred to another recording and reporting unit and whose treatment outcome is unknown. A patient who has been transferred to another reporting unit and whose treatment outcome is unknown. Treatment success A sum of cured and completed treatmentc a. These definitions apply to pulmonary smear-positive and smear-negative patients, and to patients with extrapulmonary disease. Outcomes in these patients need to be evaluated separately. b. The sputum examination may not have been done or the results may not be available. c. For smear- or culture-positive patients only. Source: WHO (2009). Treatment of Tuberculosis Guidelines, Fourth Edition. Page 97 Table 22: Treatment outcomes Category Sputum smear-positive TB outcomes: Sputum smear-negative and ETB outcomes Possible outcomes Cure Treatment completed Treatment failure Died Default Transfer out Treatment success — cure plus treatment completed “Cure” and “Treatment failure” are not possible outcomes as they depend upon sputum conversion in follow-up sputum smear examinations. Possible outcomes include: Treatment completed Died Default Transfer out An exception is a smear-negative PTB patient who becomes sputum smear-positive at 2 months. Record the outcome for this patient as “Treatment failure.” Reregister the patient as “Other” and start Category II treatment. Transfer patients Transfer out When a patient moves and TB care is transferred to another facility, record the date and mark the outcome “Transfer out” on the back of the TB Treatment Card. If the transfer is confirmed, inquire later about the treatment outcome. When the patient’s outcome is reported from the other site/facility, record final treatment outcome and the date of that outcome on the card. If outcome cannot be determined, leave outcome as “Transfer out” with the date of the transfer. Page 98 Incomplete treatment Transfer in (a) when a patient transfers care in from another health facility, contact the original facility to report the patient’s final treatment outcome. People do not complete treatment for many reasons: Death Stopped coming for treatment Cannot be located When a patient does not complete treatment, return all drugs remaining in the patient’s drug box to the drug supply room. Page 99 SOP 16: Diagnosis and treatment of resistant TB Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To diagnose, classify, treat and monitor DR-TB, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management TB-HIV specialist Supplies 1. TB Treatment Card, expanded, HIV Care/ART Card (Appendix 2), medical record and relevant registers (e.g., TB register) as per national guidelines 2. Resistance testing laboratory 3. Laboratory test referral request form, including Request for Sputum Smear Microscopy Procedure 16.1 Screen for DR-TB — HIV-infected patients failing to respond to treatment or those who experience recurrent TB episodes Infants and children: Suspect DR-TB in the following pediatric cases: A child has a close contact, such as a household member, caregiver or grandparent, with an infectious DR or MDR-TB case; A child was in contact with a TB patient who died while on treatment, and there are reasons to suspect that the patient had DR or MDR-TB; A child with bacteriologically-proven TB or probable TB is not responding to firstline anti-TB treatment where adherence is ensured. Adults, adolescents, children and infants: Differential diagnosis includes: Non-adherence to TB and HIV medications; Incorrect diagnosis of the HIV-related lung disease; Incorrectly prescribed treatment regimen; Irregular treatment due to poor drug supply; Page 100 Re-infection with TB; Severe immune-suppression; Failure of ART; Poor absorption of anti-TB drugs. If resistant TB is suspected, review: Medication adherence with the patient (or caregiver) and treatment supporter; TBIC measures (SOP 5), especially in symptomatic patients. 16.2 Provide DST Collect and send specimens from all available sources, sputum or other fluids and tissues, as described in SOP 7. Send specimens for mycobacterial culture and DST. Send specimen with the Request for Sputum Smear Microscopy, Culture, Drug Susceptibility Test; Smear microscopy cannot reliably diagnose many HIV-co-infected patients, especially in advanced HIV disease; Mycobacterial load may be high in children with advanced HIV disease allowing for higher culture yield. If available, use rapid test methods such as gene sequencing, line-probe tests, fastplaque tests on M. tuberculosis isolates or, in some cases, on smear-positive specimens. Develop a referral network or communication with specialty national and international laboratories as needed, especially if XDR-TB is suspected. Ensure that patient continues the current regimen until results are received. Follow up on laboratory results. 16.3 Make diagnosis Base pulmonary and ETB diagnosis on laboratory testing. Since sputum is sometimes difficult to collect in children, smear- and culture-negative children with active TB who are close contacts of patients with DR-TB can be started on Category IV regimens. Notify the patient and the NTP immediately if sputum grows bacilli positive for resistant TB. Definition of DR-TB: DR-TB is diagnosed when at least 1 of the pre-treatment cultures or smears was positive for DR-TB; the collection date of the sample on which the culture or smear was conducted must be less than 30 days before, or 7 days after, the start of Category IV treatment. Page 101 16.4 Initiate infection control (IC) MDR-TB Avoid admission to a general hospital ward; if isolated in a separate unit, ensure that the room is well ventilated (SOP 5); If treating as an outpatient or at home, advise patient to sleep in a separate room or space of the house that is well-ventilated; Provide routine care outside of the HIV care center until the patient is no longer infectious. XDR-TB Place XDR-TB patients on hospital ward isolation until they are no longer infectious; Explain the rationale to patient, family members and staff; avoid stigmatizing the patient; Follow a patient-centered approach; Ensure that WHO ethical and legal guidelines are met. See the WHO’s Guidance on Ethics of Tuberculosis Prevention, Care and Control 2010 for more information. 16.5 Classify Category IV patient in 2 different ways: According to history of previous anti-TB drug use New: Patient received no, or less than 1 month of, anti-TB treatment; Sputum was collected for DST at the start of a Category I regimen and then patient switched to a Category IV regimen because MDR-TB was later confirmed; DST was conducted within 1 month of the start of treatment. Previously treated with first-line drugs only, for 1 month or more; Previously treated with second line drugs, for more than 1 month, with or without first-line drugs. According to the history of their previous treatment; depends on the country’s DST target groups policy: New: Same definition as in classification “According to history of previous anti-TB drug use” (above); Relapse: A patient whose most recent treatment outcome was “cured” or “treatment completed”, then was diagnosed with TB by sputum smear microscopy or culture; Page 102 Treatment after default: A patient who returns to treatment, TB positive by sputum smear microscopy or culture, following interruption of treatment for 2 or more consecutive months; Treatment after failure of Category I: Patient received Category I treatment for TB, and treatment failed; Failure: sputum smear-positive at 5 months or later during treatment. Treatment after failure of Category II: Patient received Category II treatment for TB, and treatment failed Failure: sputum smear-positive at 5 months or later during treatment Transfer in: Patient transferred in from another register for treatment of DR-TB to continue Category IV treatment Other: Patient may not fit into any of the above categories. Classify into meaningful groups according to the local epidemiology of disease. Examples include the following: » Sputum smear-positive patients with unknown previous treatment outcome; » Sputum smear-positive patients who received treatment other than Category I or II (possibly in the private sector); » Previously-treated patients with ETB; » Patients who received several unsuccessful treatments, were considered incurable by health staff, and lived with active TB disease with no or inadequate treatment (duration depends on country situation) until Category IV treatment became available (so-called “back-log” patients). Document type and classification in medical record, TB Register and TB Treatment Card – Expanded. Adapt forms to fit DR-TB as needed or required by the national TB program. 16.6 Provide treatment (Table 22) Follow the national TB program and HIV/AIDS national guidelines, consult with TBHIV specialists, and discuss patient treatment with the medical team. 16.7 Monitor the patient Give treatment daily and under direct observation. Schedule intensive clinical, laboratory and adherence follow-up. Clinical care: Monitor clinical symptoms at baseline, and then monthly; Page 103 After conversion, collect and monitor sputum smear monthly and culture quarterly; Repeat DST for patients who remain smear- and culture-positive during treatment or when treatment failure is suspected. Usually it is not necessary to repeat DST within 3 months of treatment completion; Evaluate chest radiographs at least every 6 months, when a surgical intervention is being considered, or whenever the patient’s clinical situation worsens. Laboratory investigations: Baseline, then every 1–3 weeks: serum creatinine, potassium; Monthly: serum LFTs, hemoglobin, white blood count; Thyroid Stimulin Hormon (TSH): every 6 months if receiving ethionamide / protionamide and/or PAS. Adherence strategy: Provide intensified DOT (SOP 13) enforced by a specialized team; Offer emotional support. Monitor medication side effects and toxicity closely according to facility protocol: Expect a high incidence of adverse effects, especially when multiple DR-TB medicines are given along with ART c(children typically experience fewer treatment-related side effects); Symptomatically manage side effects whenever possible (Tables 18 and 19); Document in the patient’s medical record sides effects toxicity, and action taken; Report adverse events to NTP. Document weight (and height, for children) at each clinical visit: Evaluate the need for additional nutritional support and refer to a nutritionist; Prescribe pyridoxine to all patients receiving cycloserine or terizidone to prevent neurological adverse effects; Give vitamin (especially vitamin A) and mineral supplements where these deficiencies are prevalent; If minerals are prescribed, dose apart from the fluoroquinolones; Monitor, severe wasting, diarrheal disease, and malabsorption syndromes. Address any socioeconomic and cost issues that may affect adherence. 16.8 Determine treatment progress Review lab results: Page 104 Treatment failure is defined by persistent, positive smears at month 5; Consider conducting culture and DST earlier, based on the overall clinical picture; Switch patients found to have MDR-TB to Category IV regimens before they meet the traditional diagnosis of failure. When possible, classify these patients separately. Determine sputum conversion: 2 sets of consecutive negative smears and cultures from samples collected at least 30 days apart. 16.9 At every visit: schedule follow up and document 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: Record clinical and laboratory monitoring results in the TB Treatment Card, HIV Care/ART Card, and medical record; Complete all relevant registers as per national guidelines; Ensure that the recording and reporting system assesses the smear- and culturestatus 6 months after the start of treatment as an interim outcome. Consider using the smear and culture conversion rate at 6 months to assess the clinical effectiveness of the treatment plan. Page 105 Table 22: Groups of drugs to treat MDR-TB Group Drugs (abbreviations) Group 1: Pyrazinamide (Z) First-line oral agents Ethambutol (E) Rifabutin (Rfb) Group 2: Kanamycin (Km) Injectable agents Amikacin (Am) Capreomycin (Cm) Streptomycin (S) Group 3: Levofloxacin (Lfx) Fluoroquinolones Moxifloxacin (Mfx) Ofloxacin (Ofx) Group 4: Para-Aminosalicylic Acid (PAS) Oral bacteriostatic second-line agents Cycloserine (Cs) Terizidone (Trd) Ethionamide (Eto) Protionamide (Pto) Group 5: Clofazimine (Cfz) Agents with unclear role in treatment of drug resistant-TB Linezolid (Lzd) Amoxicillin/Clavulanate (Amx/Clv) Thioacetazone (Thz) Imipenem/Cilastatin (Ipm/Cln) High-Dose INH (High-Dose H)aa Clarithromycin (Clr) a. High-dose INH is defined as 16–20 mg/kg/day. Some experts recommend using highdose INH in the presence of resistance to low concentrations of INH (>1% of bacilli resistant to 0.2 μg/ml but susceptible to 1 μg/ml of INH), whereas INH is not recommended for high-dose resistance (>1% of bacilli resistant to 1 μg/ml of INH. Source: WHO (2009). Treatment of Tuberculosis Guidelines, Fourth Edition. Pp85. Page 106 SOP 17: Treatment supporter training and responsibilities Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To provide training and ongoing support to treatment supporters. Responsibility Nurse, other clinic staff or volunteer trained in TB-HIV co-management, skilled in adherence support, and who possesses excellent teaching skills Others technical area experts that can assist with the training Supplies 1. 2. Equipment/supplies: a. Treatment aids (e.g., calendars, pillboxes) b. Treatment cards c. Training materials Small packet containing reference information for treatment supporters Procedure 17.1 Identify the treatment supporter Once the decision has been made to initiate TB treatment or both ART and TB treatment, work with patient to identify a treatment supporter (see SOP 13). The treatment supporter can be chosen from a variety of people: Family member (partner, parent, son/daughter); Community member (teacher, spiritual guide); Friend (neighbor, support group member); Site staff or volunteer. Work with community leaders, religious leaders, and other identified advocates, and encourage them to recruit potential treatment supporters for the clinic: Recruit a small group of volunteer peer supporters from the community in case a patient is not able to identify or disclose to someone they know. Essential qualities of the treatment supporter: Chosen by or acceptable to the patient; Page 107 Respected and trusted by the patient; Accepting of the patient’s illness; Committed to supporting the patient throughout the entire treatment period; Able to be educated on the diseases, ART and DOT; Flexible in time and schedule; Understanding of confidentiality (no patient information can be shared outside of the patient, the nurse, and the physician or clinical officer). 17.2 Train the treatment supporter Identify a time/date at baseline to train the treatment supporter(s). If possible, the schedule a time when a group of treatment supporters can be trained at once. Baseline training can last as long as a few hours or a day, depending on the background of the identified treatment supporter(s). 17.3 Include the following topics in the training Provide an overview to ensure that the treatment supporter understands and accepts their responsibilities: commitment, basic health knowledge, and emergency resources for referral. Define confidentiality and provide examples to reinforce the definition: Private information includes medical care, treatments, and diagnoses; This information can be shared only with the patient, health worker, and the treatment supporter; The only person who can share the patient’s medical information is the patient. Ask treatment supporter(s) if he or she understands and accepts the above responsibilities. If so, continue with the training; if not, review again and/or consider discontinuing the training (and identifying another treatment supporter) if he or she cannot commit to the basic responsibilities of the role. Review facts about TB. (see Table 23) Review facts about HIV and ART, per site standard. Address issues of stigma surrounding TB and HIV, both as a health worker and a community member. Review how to give medications (TB treatment): Give drugs in a place with good air flow; “Daily” treatment in the beginning usually means giving 6 doses per week, or if Page 108 using a fixed dose combination (FDC) in a blister packs, 7 days per week. If the patient misses a dose (e.g., he or she is traveling, too sick to tolerate the pill, throws up the pill), give missed dose upon returning the next day: Do not give a double dose on any 1 day; Continue according to schedule; Extend treatment duration to complete all doses in the regimen; Notify the clinic of the need to extend the treatment schedule. Discuss ways the treatment supporter can remind the patient to take the medication and develop a working relationship that encourages the patient to be independent. Discuss the patient’s follow-up schedule and the treatment supporter’s role: Attend all clinic visits; Attend support group meetings, if able. Discuss how the treatment supporter can help the patient remember or keep track of test results and clinic visits throughout the course of the treatment. Review signs/symptoms of health worker burn-out: (see Table 24) Encourage the treatment supporter to identify burn-out early; Prevent supporter drop-out. (see Table 25) Review how the clinic will support the treatment supporter: Provide transportation, if feasible; Provide psychosocial support; Ensure a quick way to reach a clinic staff member in case of a patient or supporter emergency. Provide the treatment supporter with a small packet of reference information that includes: (see SOP 18) Important information about TB, HIV; Referral contact information; Tools for DOT visits (e.g., TB Treatment Card, clipboard, pens, pencils, bag/backpack). 17.4 Ensure treatment supporters understand their ongoing responsibilities Discuss with treatment supporters treatment-related issues: Store the medications; Observe the patient swallowing the drugs on a daily basis; Page 109 Tailor method of observation to patient’s needs; Demonstrate respect for the patient; Troubles shoot medication adherence barriers. Record each daily dose that was swallowed on a TB Treatment Card; Coordinate with site staff to collect medications (from the facility or dispensary) and discuss with facility staff TB Treatment Card documentation and patient adherence. Discuss with treatment supporters the patient’s health status: Refer patient to clinic and notify clinic of serious side effects, physical symptoms of side effects, or other infections (SOP 14); Monitor the health status of family and other community members who come in contact with the patient on a regular basis; refer them to the clinic as needed. Discuss with treatment supporters advocacy and support: Discuss how the patient is feeling, regarding symptoms, treatment, and emotions; Discuss any concerns the patient raises during conversation; Notify the clinic of key problems, including: Worsening health status Problems taking medications that are not fixed Food insecurity Housing issues, including moving for work, family reasons Interpersonal conflicts with household members, friends Reinforce the need for adherence to the medication schedule and clinic visits. 17.5 Provide treatment supporters with ongoing support Encourage treatment supporters to take care of themselves: Provide information about TB and HIV prevention and other disease prevention, such as sexually transmitted infections (STIs); Discuss and reinforce positive living strategies, including nutrition, exercise, support groups, and volunteerism. Offer regular (e.g., monthly) treatment supporter meetings; schedule follow-up training, including training based on needs, interest, or new developments. Ensure the following are available to treatment supporters: Group support meetings, to discuss experiences, medications, referrals and provide a forum that will prevent burn out; Individual meetings, when supporter picks up patient medications. Page 110 Table 23: Basic TB information Tuberculosis… Is caused by a germ that cannot be seen. Is found most often in infected people’s lungs. Is spread through the air when someone coughs or sneezes. Can be stopped from spreading by covering one’s mouth when coughing or sneezing. Most often shows up as a cough that lasts more than 2 to 3 weeks; other symptoms (fever, night sweats) may occur, too. Can be cured by taking medications exactly as prescribed for the full treatment schedule until all doses are taken. Is no longer infectious once a patient takes anti-TB drugs exactly as prescribed for 2 weeks. TB may become incurable if… The patient does not take all TB medications exactly as prescribed. To prevent the spread of TB… Take all prescribed medicines. Cover the mouth and nose when sneezing and coughing. Keep windows and doors open in the household to allow fresh air flow. Adapted from WHO “Tuberculosis Care with TBHIV Co-management,” 2007. Source: FHI (2009). Collaborative TB-HIV Services: Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites. Page 111 Table 24: Signs/symptoms of treatment supporter burnout Recognize burnout: Irritability, anger. Poor sleep. Poor concentration. Avoidance of patients and problems — withdrawal from others. Fatigue. Emotional numbing—lack of pleasure. Resorting to alcohol or drugs. In survivors of multiple loss—afraid to grieve. Source: WHO (2007). Chronic HIV Care with ART and Prevention. Table 25: Preventing and responding to burnout How to prevent and respond to burnout: Be confident that you have the skills and resources to care for the patient and family. Define for yourself what is meaningful and valued in care giving. Discuss problems with someone else. Be aware of what causes stress and avoid it. Use strategies that focus on problems, rather than emotions. Change approach to care giving: Divide tasks into manageable parts (small acts of care); Learn how to adjust the pace of caregiving; Ask others to help; Encourage self-care by the patient. Use relaxation techniques. Take care of your life outside of the caregiving (maintain your other interests, identify support for yourself, spend time with family and friends). Source: WHO (2007). Chronic HIV Care with ART and Prevention. Page 112 SOP 18: TB and HIV co-infection patient education Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To provide TB-HIV co-infected patients with education and support, as part of comprehensive TB-HIV care, treatment and support services. Responsibility Physician or clinical officer trained in TB-HIV co-management Nurse or nurse assistant trained in TB-HIV co-management Clinical care nurse/adherence nurse counselor Supplies 1. Medical record and relevant registers (e.g., TB register) as per national guidelines 2. Equipment/supplies: a. Treatment aids (e.g., calendars, pillboxes) b. Patient information brochures, if available Procedure 18.1 Provide education (usually led by a clinical care nurse/adherence nurse counselor and guided by the clinician’s assessment) Provide education at every clinic visit; provide education to patients, family and household members, and treatment supporters. Provide education whenever a patient, family member, household member, treatment supporter, or other person asks a question about TB, HIV, or another related topic. When providing education, always demonstrate a caring, nonjudgmental and respectful attitude. Give the patient 100% of your attention during appointments. Praise and encourage the patient for asking questions and completing milestones throughout the treatment, such as: Completing the initial TB medication phase; Adhering to a TB-HIV medication regimen; Managing mild to moderate side effects of medications and the disease process. First, ask questions to assess the current level of education about the disease. Provide messages based on the respondent’s answers. Table 26 includes suggested Page 113 questions and answers. Offer motivational statements throughout treatment duration. (see Table 27) Review issues related to HIV and TB. Transmission; How TB and HIV care are interrelated. After finishing the question and answer session, ask review questions to make sure the patient fully understood the information discussed. Make sure the patient knows what to do before leaving the clinic; Reinforce earlier messages and give more information as needed. 18.2 Support disclosure Support disclosure of TB and HIV status. Discuss advantages; Discuss concerns of disclosure to partner, family members, children, and friends: If patient has not disclosed yet, assess readiness to disclose disease status; Assess social network; encourage disclosure to the most trustworthy person first; Assess social support and needs; Reassure the patient that you will keep results confidential; Offer another appointment if needed; offer more help as needed, such as peer counselors. Always ask the patient if she/he has any further questions before completing the appointment. 18.3 At every visit: schedule follow up and document Schedule follow-up visit; record appointment in follow-up register. Document: Document educational session completed in the patient’s medical record; Complete all relevant registers as per national guidelines; Page 114 Table 26: TB knowledge assessment tool Questions (and answers) to assess patient knowledge about TB Q: What do you think tuberculosis is? How do you think may have contracted TB? A: Tuberculosis, or TB, is an illness caused by a germ that is breathed into the lungs. The TB germs can settle anywhere in the body, but they most often land and stay in the lungs. When TB hurts or damages the lungs, a person coughs up sputum from the lungs and cannot breathe well. Without the correct medication, a person can die from TB. Q: Have you ever known anyone with TB? What happened to that person? Do you know that TB can be cured? A: TB can be cured with the correct medication treatment. A patient must take every recommended drug for the entire treatment time to be cured. TB drugs are free of charge. Patients do not have to pay for their anti-TB medications. You can take your TB medications without changing your daily routine or work schedule. Q: How do you think TB is spread? A: TB spreads from 1 person to another when an infected person coughs or sneezes and sprays TB germs into the air. When that happens, other people breathe in the germs and may become infected. Germs pass easily to family and other household members when many people live together in a close space. Anyone can get TB, but not everyone infected with TB will become sick. Q: How can you avoid spreading TB? A: If you take your anti-TB medications on a regular basis (daily, every other day), in 2 weeks you will no longer be contagious. You will need to take your medications much longer (6–36 months), to be cured, but you won’t be able to pass it onto anyone else after 2 weeks on medication. Also, if you cover your mouth and nose when coughing or sneezing you will prevent spreading it further. In addition: Open windows and doors to allow fresh air through the home; use a fan if available. Use sunlight to dry clothes outside during the morning hours. Use UV lights, if available. There is no need to eat special foods if infected with TB and taking anti-TB medications; but you should always try to eat balanced meal. Page 115 There is no need to use separate plates, dishes, or household items when you have a family member on TB treatment. Do not spit on the ground in the home, outside the home, in the general workplace, or in the community. Spit sputum into a disposable paper, tissue, or old cloth and discard by burning, burying, or placing in toilet or covered garbage receptacle if available. Q: How many people live with you, and what ages are they? Does anyone else in your household have a cough? If so, who? A: All children under 5 years of age living in the household should be evaluated for TB symptoms; children this age are at risk of severe forms of TB. Young children may need preventive medications or referral to a specialist for evaluation. Other household members, especially if HIV-infected, need to be tested for TB, especially if they have cough. Q: Can you explain why it is important that somebody else observes and supports you while you swallow your TB and/or HIV medications? A: A good health service should ensure that a patient takes every medicine dose without any problem. If problems come up, the health service is there to help. A health worker must watch you swallow all your prescribed TB and HIV drugs according to the prescribed schedule. This will ensure that you take the correct drugs for the correct period of time. If you need to take injections to cure TB, they will be given safely. When a health worker sees you on a regular basis, the health worker will see if you have side effects or other problems from the drugs and/or disease. If you do not take all of your prescribed drugs, you will continue to spread TB to others in your family and community and your TB will not be cured. It is dangerous to stop or take a break from treatment. If you do this, the disease may never be cured. With DOT, the health worker will know if you miss a dose and will quickly find out the problem. If you must travel, or move away, tell the health worker so plans can be made to continue your treatment without taking any breaks. Q: How long should you take your anti-TB drugs? How frequent and where are your clinic visits? A: The medication and clinic visit schedule is individualized for each patient: treatment length, visit frequency, and where to go for treatment. If preassembled drug boxes are used, all the drugs needed to treat TB (and HIV, if applicable) are kept in a box with the patient’s name on it so the clinic will not run out of medications. Page 116 Q: What should you expect when taking the drugs? What should you do next? A: If you are taking rifampicin, your urine may turn orange/red. This color is expected and not harmful. If you feel nauseous from the drugs, bring a bit of food to eat at the time you take your next dose. TB and HIV treatment does not have to interrupt normal life and work. In addition: Be sure that the patient knows exactly where and when to go for the next treatment visit. Ask questions to be sure the patient can make the next scheduled visit and that the patient is committed to return to the clinic. Remind the patient to bring family, friends, and other close contacts for TB testing. Source: WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI). Table 27: Motivational statements Motivate the patient with statements such as the following: TB can be cured if you keep coming for the medicine, and then you will not have to worry about it anymore. You only have ____ more doses to take every day. After that, you will come less often. These are the safest, most effective drugs available to treat TB anywhere in the world. Almost all patients who take their medicines as recommended are cured. If you keep taking your medicine, you will not spread TB to your family. Taking only some of the drugs, or taking them irregularly, is dangerous and can make the disease difficult or impossible to cure. Source: WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI). Page 117 References AIDS Education & Training Centers National Resource Center (July 2006; updated July 2007). Treatment of Latent Tuberculosis in Resource‐ Limited Settings. http://www.aidsetc.org/aidsetc?page=cm‐210_latent_tb American Thoracic Society, CDC, and Infectious Diseases Society of America. Treatment of Tuberculosis. MMWR Recommendations and Reports. June 20, 2003 / 52(RR11); 1‐77. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5211a1.htm Ammann, A. (April 2002; updated September 2006). Summary and Recommendations: Cotrimoxazole Prophylaxis for HIV‐ Related Infections in Adults, Infants, and Children in Resource‐ Limited Settings. Global Strategies for HIV Prevention. http://www.womenchildrenhiv.org/wchiv?page=ch‐04‐01 Bartlett JG, Gallant JE. (2007). Medical Management of HIV Infection. Johns Hopkins University, Baltimore, MD. Centers for Disease Control and Prevention (January 2008). TB and HIV/AIDS. http://www.cdc.gov/hiv/resources/factsheets/PDF/hivtb.pdf Centers for Disease Control and Prevention (March 2003). Treatment of Drug‐ Susceptible Tuberculosis Disease in HIV-Infected Persons. http://www.cdc.gov/tb/pubs/tbfactsheets/treatmentHIVpositive.pdf Division of Tuberculosis Elimination (September 14, 2008). Fact Sheets: Treatment of Latent TB Infection. http://www.cdc.gov/TB/pubs/tbfactsheets/treatmentLTBI.htm Family Health International (May 2006). Core Services for Comprehensive HIV/AIDS Clinical Care and Treatment. Standard Operating Procedures. Family Health International (May 2006). Comprehensive Prevention of Mother‐ to‐ Child Transmission of HIV Infection (PMTCT), Generic Version. Family Health International (May 2006). Antiretroviral Therapy for Infants and Children. Standard Operating Procedures. Family Health International (2005). Standard Operating Procedures for ART Adherence Counseling. Standard Operating Procedures. Family Health International. Standard Precautions for the Outpatient Setting. Standard Operating Procedures. August 2005. Family Health International (May 2006). HIV Clinical Care for Adults and Adolescents. Standard Operating Procedures. Gallant JE, Editor. HIV Guide — Zambia. Johns Hopkins POC-IT Center, Point-of-Care information technology. http://www.zambiahivguide.org/guidelines/index.html?navigationId=429785&siteId=429188#4 29785 Gever J. XDR‐TB Succumbs to Multi‐Drug Regimen. (August 06, 2008). Medscape Today. http://www.medpagetoday.com/InfectiousDisease/Tuberculosis/10460 Henry J. Kaiser Family Foundation. Early Antiretroviral Treatment for People with HIV/TB Coinfection Could Reduce Mortality by Half, Study Says. September 19, 2008. Medical News. Kaiser Daily HIV/AIDS Report. http://www.thebodypro.com/content/art48674.html Page 118 Khan AN, Chandramohan M, MacDonald S. Tuberculosis (Updated: Apr 21, 2008). Genitourinary Tract. eMedicine from WebMD. http://emedicine.medscape.com/article/381509‐overview Loeffler AM. Pediatric tuberculosis (2003). Seminars in respiratory infections. Vol. 18 (4)272‐291. http://cat.inist.fr/?aModele=afficheN&cpsidt=15413754 National AIDS Control Organization & Central TB Division (2008). The HIV- TB- Co-infection Program Coordination Guidelines for Clinicians & Standard Operating Procedures. Ministry of Health and Family Welfare. Nirman Bhawan, New Delhi-110011. Available from delhisacs.org/naco_pdf/HIV-TB_guidelines.pdf Partners in Health (2008). The PIH Guide to the Community-Based Treatment of HIV in Resource-Poor Settings. Revised Second Edition. Phuljhele,NL (2007). Latest in Childhood Tuberculosis Management According to RNTCP Approved by IAP. Comped 2006 ‐ Conference Abstracts. Pediatric On call [serial online] [cited 15 January 2007 (Supplement 1)];4. Available from: http://www.pediatriconcall.com/fordoctor/Conference_abstracts/comped/Tuber.asp Rabkin, El‐Sadr, and Abrams (September 2004). Diagnosis and Management of HIV‐related Tuberculosis. Chapter 5.5. The Columbia Clinical Manual. http://www.columbiaicap.org/resources/tbhiv/trainingresources/tb_guide1.pdf Smith, M. (October 17, 2008). Combining HIV and TB Therapy Saves Lives. Medical News: HIV/AIDS. Medpage Today. http://www.medpagetoday.com/HIVAIDS/HIVAIDS/11367 TB-HIV Working Group. Two Diseases, One Patient TB-HIV Control Strategy, Towards 2015. Powerpoint presentation, 2005. Stop TB Partnership. http://www.stoptb.org/news/archives/iacxv/TBHIVInformationPack.asp Vannarith C, Kanara N, Qualls M, Varm J, Laserso K, Wells C, Cain K. (January 2004– February 2005). Screening HIV‐Infected Persons for Tuberculosis, Cambodia. MMWR Weekly. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5446a2.htm WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIVinfected children: Recommendations for a public health approach. World Health Organization, Department of HIV/AIDS (2011). Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. http://whqlibdoc.who.int/publications/2011/9789241500708_eng.pdf World Health Organization (2010). Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach. 2010 revision. Geneva, World Health Organization. http://whqlibdoc.who.int/publications/2010/9789241599764_eng.pdf World Health Organization (2004). A guide to monitoring and evaluating collaborative TB-HIV activities. Field test version. Geneva, World Health Organization. http://whqlibdoc.who.int/hq/2004/WHO_HTM_TB_2004.342.pdf World Health Organization (2009). Treatment of tuberculosis: guidelines – 4th ed. World Health Organization (2006). Guidelines for the programmatic management of drug- resistant tuberculosis. Geneva, World Health Organization, 2006. http://www.who.int/tb/publications/2006/who_htm_tb_2008_402.pdf Page 119 World Health Organization (2010). Implementing the WHO Policy on TB Infection Control in Health Care Settings, Congregate Settings and Households. Geneva, World Health Organization. World Health Organization. HIV Care/ART Card. Accessed June 2009. http://www.who.int/hiv/pub/imai/primary_artcard/en/print.html World Health Organization (August 2008). Priority Interventions. HIV/AIDS prevention, treatment and care in the health sector. http://www.who.int/management/programme/aids/Priority_interventions_HIV.pdf World Health Organization (2006). Revised TB recording and reporting forms and registers — version 2006. World Health Organization (2004). TB-HIV: A clinical manual. Second edition. http://whqlibdoc.who.int/publications/2004/9241546344.pdf World Health Organization (2003). Treatment of Tuberculosis: Guidelines for National Programmes. Geneva, World Health Organization. World Health Organization (2007). Tuberculosis care with TB- HIV- Co-management. Integrated management of adolescent and adult illness (IMAI). April 2007. Geneva, World Health Organization. World Health Organization (1999). Addendum to WHO Guidelines for the Prevention of Tuberculosis in Health Care Facilities in Resource Limited Settings, 1999. http://www.cdc.gov/nchstp/od/gap/docs/6x9TB%20Booklet_1-4-07.pdf World Health Organization (2009). Management of MDR-TB: a field guide: a companion document to guidelines for programmatic management of drug-resistant tuberculosis : integrated management of adolescent and adult illness (IMAI). Available from: http://whqlibdoc.who.int/publications/2009/9789241547765_eng.pdf Page 120 List of tables and figures Table 1: TB assessment, WHO (2007). Tuberculosis Care with TB-HIV CoManagement: Integrated Management of Adolescent and Adult Illness (IMAI). ................ Table 2: Providing family-centered care ............................................................................ Table 3: Examples of process indicators. Adapted from: ICAP (November 2010). TBHIV Standards of Care, Standard Operating Procedures for assessing TB-HIV SOCs Figure 1: Algorithm for TB screening in children with HIV in HIV-prevalent and resource constrained settings, WHO (2011). Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings................................................................................. Figure 2: Algorithm for TB screening in adults and adolescents living with HIV in HIV-prevalent and resource-constrained settings, WHO (2011). Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. .............................................................. Table 4: Expectorated sputum, WHO, Guidance for national tuberculosis programmes on the management of tuberculosis in children ............................................ Table 5: CXR findings in HIV-infected adults and children with PTB, WHO (2004). TB-HIV: A Clinical Manual, Second Edition and WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for National Tuberculosis and HIV Programmes on the management of Tuberculosis in HIVinfected Children: Recommendations for a Public Health Approach. ............................... Figure 3: Algorithm for the diagnosis of tuberculosis in ambulatory patient in HIV-prevalent settings, WHO (2007). Improving the diagnosis and treatment of smear-negative pulmonary and extrapulmonary tuberculosis among adults and adolescents: Recommendations for HIV-prevalent and resource-constrained settings. ............................................................................................................................. Figure 4: Suggested clinical characteristics to assist the diagnosis of extrapulmonary tuberculosis (ETB), WHO (2007). Improving the diagnosis and treatment of smear-negative pulmonary and extrapulmonary tuberculosis among adults and adolescents: recommendations for HIV-prevalent and resourceconstrained settings .......................................................................................................... Table 6: Standard regimen and dosing frequency for new TB patients (adults and children >12 years), WHO (2009). Treatment of Tuberculosis Guidelines, Fourth Edition. ................................................................................................ Table 7: Standard regimens for previously treated patients depending on the availability of routine DST to guide the therapy of individual retreatment patients, WHO (2009). Treatment of Tuberculosis Guidelines, Fourth Edition. .............................. Page 121 Table 8: Recommended pediatric TB treatment regimen, WHO (2006). Guidance for national tuberculosis programmes on the management of tuberculosis in children.............................................................................................................................. Table 9: Recommended doses of CTX by age and weight, WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. Table 10: Summary of eligibility criteria for ART for HIV-infected children by age, WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. .......................................................................................................................... Table 11: ART regimen choices in children who have started TB treatment, WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. .......................................................................................................................... Table 12: Recommended changes to ART management when commencing antiTB treatment in children, WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. ............................................................................................. Table 13: Timing of ART initiation in relation to clinical stage of TB, WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. ........................... Table 14: Common side effects in patients on TB-ART co-treatment and recommended responses, WHO (2007). Tuberculosis Care with TB-HIV CoManagement: Integrated Management of Adolescent and Adult Illness (IMAI). ................ Table 15: Possible causes of missing doses and possible solutions, WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI), pp 63 and 71. ........................................................... Table 16: Treatment interruption guidelines, WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI). .................................................................................................................... Table 17: Symptoms related to TB drug toxicity in children, FHI (2009). Collaborative TB-HIV Services: Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites. ................................ Table 18: Minor symptoms associated with anti-TB treatment in adults, FHI (2009). Collaborative TB-HIV Services: Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites. ................................ Page 122 Table 19: Major side effects of anti-TB drugs, FHI (2009). Collaborative TB-HIV Services: Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites. ...................................................................................... Table 20: Adverse reactions to ARVs and their management, WHO and International Union Against Tuberculosis and Lung Disease (2010). Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach. ........................... Table 21: Definitions of treatment outcomes, WHO (2009). Treatment of Tuberculosis Guidelines, Fourth Edition. ........................................................................... Table 22: Treatment outcomes ......................................................................................... Table 22: Groups of drugs to treat MDR-TB, WHO (2009). Treatment of Tuberculosis Guidelines, Fourth Edition. ........................................................................... Table 23: Basic TB information, FHI (2009). Collaborative TB-HIV Services: Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites. ...................................................................................................... Table 24: Signs/symptoms of treatment supporter burnout, WHO (2007). Chronic HIV Care with ART and Prevention. Table 25: Preventing and responding to burnout, WHO (2007). Chronic HIV Care with ART and Prevention. ......................................................................................... Table 26: TB knowledge assessment tool, WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI). .................................................................................................................... Table 27: Motivational statements, WHO (2007). Tuberculosis Care with TB-HIV Co-Management: Integrated Management of Adolescent and Adult Illness (IMAI). .......... Page 123 Appendices Page 124 Appendix 1: TB Treatment Card BMU TB Register No. Tuberculosis Treatment Card Name: Sex: M F Age: Address: Disease site (check one): Date of registration: Health facility: Pulmonary Name / address of community treatment supporter (if applicable): I. INITIAL PHASE: prescribed regimen and dosages CAT (I, II , III): Number of tablets per dose and dosage of S: (RHZE) S Cotrimoxazole ARV Other Extrapulmonary, specify: Type of patient (check one): New Treatment after default Relapse Treatment after failure Transfer in Other, specify: Referral by: Self-referral Community member Public facility Private facility/provider Other, specify: Sputum smear microscopy Month 0 Date Lab No. TB-HIV Date: Result Weight (kg) Result HIV test CTX start ART start TICK APPROPRIATE BOX AFTER THE DRUGS HAVE BEEN ADMINISTERED * (Pos) Positive; (Neg) Negative; (I) Indeterminate; (ND) Not Done/unknown Daily supply: Enter Periodic supply: enter X on day when drugs are collected and draw a horizontal line ( ) through the number of days supplied. Ø = drugs not taken Day / 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Month II. CONTINUATION PHASE: Number of tablets per dose: (RH) (RHE) Other Daily supply: Enter Periodic supply: enter X on day when drugs are collected and draw a horizontal line ( ) through the number of days supplied. Ø = drugs not taken Day / 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Month X-ray (at start) Date: Results (-), (+), ND: HIV Care Pre ART Register No. CD4 result ART eligibility (Y / N / Unknown) Date eligibility assessed ART Register No. Comments Treatment outcome: Date of decision: Cure Treatment completed Died Treatment failure Default Transfer out Name and address of contact person: Source: World Health Organization (April 2007). Tuberculosis care with TBHIV Co-management. Integrated management of adolescent and adult illness (IMAI). Page 125 Appendix 2: HIV Care / ART card Unique #: HIV Care/ART Card District: Name: Sex: M F Address: Health Unit: Date Confirmed HIV+ test: Where: HIV 1 2 Ab / PCR if <18 mo Enrolled in HIV care ARV Therapy: COHORT: Medically Clinical eligible stage Why eligible: Clinical only CD4 #/% TLC Medically eligible and ready for ART Transferred in from: ART started: District clinician/team: Patient Clinic No.: Marital status: DOB: Phone (whose): Prior ART: Transfer in with records Earlier ARV, not transfer in PMTCT only None Age HIV status Unique #: Unique No. ART treatment interruptions Stop Lost Date if (circle) Date Why Restart: Stop Lost Stop Lost Stop Lost Stop Lost HIV Care/ART Card Name: Duration Date since first Check if starting scheduled. ART/since Write in starting alternate Followcurrent pick-up if ill up Date regimen Pregnant PMTCT? Due date or FP— no FP/yes: Methods Function: WHO ___ If child: Work / Amb Clinical Wt Height / Bed Stage TB Status Why New Why Switch to 2nd line (or Substitute within 2nd line): New regimen Why New Why New Why Dead Transferred out To where: Why STOP codes: 1. Toxicity/side effects 2. Pregnancy 3. Treatment failure 4. Poor adherence 5. Illness, hospitalization 6. Drugs out of stock 7. Patient lack finances 8. Other patient decision 9. Planned Rx interruption 10. Other Cotrimoxazole New opportunistic Potential infection, SIDE Other EFFECTS PROBLEMS Dispense Names of family members also in care Substitute with first line: New regimen Adhere Phone: Home-based care provided by: Function Why SUBSTITUTE or SWITCH codes: 1. Toxicity/ side effects 2. Pregnancy 3. Risk of pregnancy 4. Due to new TB 5. New drug available 6. Drug out of Stock 7. 0ther reason (specify) Reasons for SWITCH to 2nd-Line Regimen only: 8. Clinical treatment failure 9. Immunologic failure 10. Virologic failure Other meds dispensed ARV Drugs Dispense 2nd line Treatment supporter/med pick-up if ill: Address: At start ART: Weight Clinical stage Adherence 1st line Start ART first-line – initial regimen: Care entry point: PMTCT Medical Under 5 TB STI Private/Co Inpatient: IDU Adol Sex Self-refer CBO Outpatient Outreach Other: Refer or consult or link/ provide RPR, TLC, other Hospital CD4 lab days–no. Source: World Health Organization. HIV Care/ART Card. Accessed June 2009. http://www.who.int/hiv/pub/imai/primary_artcard/en/print.htm Page 126 Appendix 3: Sample TB-HIV referral/transfer form Ministry of Health and Social Welfare TB-HIV 03 National TB/Leprosy Programme TANZANIA TB-HIV REFERRAL / TRANSFER FORM District: Patient District TB ID number: Patient name: Physical address of patient: Name and address of treatment supporter: Referred from: Referred to: Indication for referral: a) For HIV care and treatment b) For VCT services Date started treatment: / / 20 Type of treatment: RHZE/RH SRHZE/RHZE/RHE SRHZE/RHZE/RH3E3 RHZE/EH Other drugs patient is receiving including ART, CTX: Remarks including side-effects and allergy: Name of clinician: Signature: Date of referral: / / 20 District code: Age (yrs): If moving, future address: Sex (M/F): (name of TB treatment clinic/health facility) (name of CTC/health facility, VCT, PMTCT) d) Support services (spiritual or community) e) Others* (specify) Tel. No.: Official stamp: *Medical, surgical, psychiatry, etc. For use by CTC/health facility, VCT, PMTCT, Support Services and Others Name of facility: District: Patient name: Patient District TB ID number: The above patient reported at this unit on: / / 20 Patient HIV Care Registration No.: Action taken: Name of Clinician/Service Provider: Signature: Date of feedback: / / 20 Official stamp: Remarks: Return this part to referring/transferring facility as soon as patient has reported. Source: Manual of the National Tuberculosis and leprosy Program in Tanzania. Fifth edition (2006). Page 127 Appendix 4: Sample report on TB-HIV notifications Ministry of Health and Social Welfare TB-HIV 01 National TB/Leprosy Programme QUARTERLY REPORT ON TB-HIV NOTIFICATIONS District: District code: Notification during quarter: of 20 Name of DTLC: Date prepared: / / 20 Signature: Date received by RTLC: / / 20 Date received by RTLC: / / 20 F M F M F M F M F M F M Facility Based DOT New sputum smear microscopy pos. TB Other** Home Based DOT New sputum smear microscopy pos. TB Other** Total New sputum smear microscopy pos. TB Other** * Documented evidence of HIV test, ART or CTX performed during or before TB treatment in any facility are reported here. ** Includes all other TB cases except “Transferred In” (i.e., smear negative, smear not done, extrapulmonary cases and all previously treated cases). ART = Anti-Retroviral Treatment CTC = Care and Treatment Clinic CTX = Cotrimoxazole Source: Manual of the National Tuberculosis and leprosy Program in Tanzania. Fifth edition (2006). Page 128 Appendix 5: Sample infection control (IC) assessment tool TB Infection Control Assessment Tool Facility name: Date of assessment: Instructions for completion: 1. 2. 3. Completed by: Circle the response most applicable to your institution. Total the scores in the place provided Retrieve last month’s assessment and complete the column ‘Last month’s score’ (LMS) Note improvements and declines in this month’s assessment compared to last month’s assessment. 1. Supporting structures and activities to ensure implementation of TB infection control interventions: 1.1. 1.2. 1.3. 1.4. 1.5. 1.6. 0 No No No No No No Some (no proof) No Does your facility have an Infection Prevention and Control Committee? Did this committee meet within the last 4 weeks? Is there a TB Infection Control Plan for the facility? Is the TB infection control plan displayed in a public place? Were TB infection control measures assessed within the last 5 weeks? Were staff trained in TB infection control this month? 1.7. Were all newly diagnosed HIV+ clients screened for TB symptoms (cough, loss of weight, night sweat)? 1.8. Were health talks given to waiting clients which included a message about TB symptoms and diagnosis? 1.9. Were any maintenance activities undertaken during the last 4 weeks on structures which improve TB infection control (e.g. air conditioning, fans, UVGI fittings? Total score: (maximum =18) 1 Some staff Some (proof available) No 2 Yes Yes Yes Yes Yes Yes Yes (proof available) Yes Yes 2. Administrative controls: Strategies to reduce generation of infectious aerosols: 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 Are patients screened for cough as they enter your facility? Are patients educated in cough hygiene as they enter your facility? If patients cough, are they provided with masks/tissues to reduce infectious aerosols? Are TB suspects/patients separated from those who are not? Are TB suspects given priority to ensure shorter waiting times in outpatient facilities? Were staff reminded of the need for ‘early TB diagnosis’ during this month? Are there separate and ventilated facilities for sputum collection from suspects? Is there a ‘fast-queue’ for collection of sputum smear results? What is the laboratory turn-around time for sputum AFB/microscopy for the last sputum AFB result received? Total score: (maximum =18) 0 No No No No No No No No >72 hours 1 Occasionally Occasionally Occasionally Occasionally Occasionally Yes, but not ventilated 48–72 hours 2 Yes Yes Yes Yes Yes Yes Yes Yes <48 hours 3. Environmental controls: Strategies to remove infectious aerosols after generation: 4.1 4.2 4.3 4.4 4.5 4.6 Are the windows in your facility kept open during working hours? Are the windows in your facility kept open during working hours? Are fans used to increase circulation of air in your area of work? Do you know the direction of airflow in each consultation room in your facility? Do staff in consultation rooms sit with their back towards the direction of airflow? Are ultraviolet germicidal irradiation facilities in use in high risk areas? Total score: (maximum =12) 0 No No No For none Uncertain No 1 Occasionally Occasionally Occasionally Only for some Occasionally 2 Yes Yes Yes Yes Yes Yes 4. Personal risk reduction strategies to reduce inhalation of infectious aerosols*: 4.7 Were staff screened for TB infection symptoms this month? No Some staff Yes 4.8 Were staff encouraged to know their HIV status this month? No Some staff Yes 4.9 Were staff reminded of the risks of TB for people who are living with HIV this month? No Some staff Yes 4.10 Were staff trained to recognize and diagnose TB this month? No Some staff Yes 4.11 Are N95 respirator/masks available this month? No Sometimes Yes 4.12 Were N95 respirator/masks used by staff in high risk services this month (e.g. TB, coughing queue)? No Sometimes Yes Total score: (maximum =12) *For this section, complete by asking one staff member at random. If some staff were asked or trained but the requested staff member was not, complete the response as ‘some staff’. Source: Reproductive Health & HIV Research Unit (RHRU) of the University of the Witwatersrand, South Africa. (Nov 2009). Implementing TB Infection Control in health facilities RHRU HIV Management Cluster. First edition Page 129 Appendix 6: Visual representation of sputum collection procedure Adopted from The Sputum Collection Procedure Visual Guide, created for use in clinics in South Africa with support from USAID through the TASCII TB Project managed by University Research Co., LLC. Content developed by URC-CHS and Kwikpoint Page 130 Appendix 7: TB screening tool for children (ICAP) Name: ART#: Date of Screening Age Gender: Male Female Date of Birth: ___/___/_____ __/___/__ __/___/__ __/___/__ __/___/__ __/___/__ __/___/__ 1. Is child currently receiving anti-TB medications? (Yes or No) Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No diagnosed with pulmonary TB in the past 12 months? Yes No (Yes or No) Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No failure to thrive during the past 3 months, not responding to nutritional rehabilitation Yes No Yes No Yes No Yes No Yes No Yes No Does child have fever? Yes No Yes No Yes No Yes No Yes No Yes No If Yes, STOP Screen. Rescreen after completion of TB Treatment. If No answer questions below. 2. Is child currently receiving INH preventive therapy? (Yes or No) 3. TB Exposure History: Close contact with a person 4. TB Symptom Screen: Does the child currently have any of the following TB symptoms? (Yes or No) a. Does child currently have cough? b. Does child have documented weight loss or c. Screening Results: (A through C above) Positive = presence of 1 or more of symptoms Negative = absence of all symptoms Positive Negative Positive Negative Positive Negative Positive Negative Positive Negative Positive Negative 5. Follow-up a. Child has No Exposure to TB and TB Screen Negative: Re-screen in 6 months. Write date for next screen. b. Child has Exposure to TB and /or Positive Symptom Screen: Child is a TB Suspect and needs to be evaluated for TB disease. This includes physical exam, CXR, sputum for AFB or gastric aspirate (GA) or Induced sputum (IS). __/___/__ __/___/__ __/___/__ __/___/__ __/___/__ __/___/__ CXR AFB Smear GA IS CXR AFB Smear GA IS CXR AFB Smear GA IS CXR AFB Smear GA IS CXR AFB Smear GA IS CXR AFB Smear GA IS 6. Nurse Initial/Signature Page 131 Appendix 8: Sample TB screening tool for adults (1) Annex : TB Screening Questionnaire Ministry of Health and Social Welfare Collaborative TB-HIV Activities TB SCREENING QUESTIONNAIRE FOR ABOVE 6 YEARS AND ADULT HIV/AIDS PATIENTS Patient’s name: CTC Reg. Number: Physical Address: Area leader/neighbor: Contact telephone (if available): Date Tick appropriate response Date of birth: Sex: Male Female Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Cough for 2 weeks? Coughing up bloodstained sputum (haemoptysis)? Fevers for 2 weeks? Noticeable weight loss for new patients or a 3 kgs weight loss in a month (subsequent visit)? Excessive sweating at night for 2 weeks? If ‘YES’ to 1 or more questions, enter the code “TB Susp” in the TB status column of the CTC2 form and complete the respective column in the table below: Date Do sputum smear for AFB and enter results (pos / neg) If sputum negative, do chest X-ray and enter result (suggestive or not suggestive) Outcome of assessment (TB or No TB) If ‘NO’ to all questions: Do not initiate TB investigations and repeat screening at the subsequent visit. Enter the code “NO” in the TB status column of the CTC2 form. Source: Manual of the National Tuberculosis and leprosy Program in Tanzania. Fifth edition (2006). Page 132 Appendix 9: Sample TB screening tool for adults (2) TUBERCULOSIS SCREENING TOOL FOR ADULTS Surname: First Name: Address: Contact number: Date: Patient record or Folder number: Reason for screening: TB contact MDR/XDR TB Contact HCT / PMTCT / VCT / CCMT / ART Symptoms Do you have a cough (24 hours or more)? Do you have loss of weight? Yes No Do you sweat a lot at night? Do you have fever? If “yes” to 1 or more of the questions, suspect TB Clinically evaluate the patient using national guidelines for diagnosing TB. If required, refer for further investigations, including sputum for microscopy and culture. If “no” to all questions, inform the patient of the benefit of INH preventive therapy (TB preventive therapy) and assess patient eligibility or refer the patient for INH eligibility Yes No TB suspect? Sputum collected? Do you sweat a lot at night? INH preventive therapy started / referred for INH preventive therapy Patients referred to the clinic: Name of counselors / health worker: Facility / contact details: Source: National Department of Health, South Africa; South African National AIDS Council (2010). Clinical Guidelines for the Management of HIV/AIDS in Adults and Adolescents. Page 133 Appendix 10: Sample AFB request form REQUEST FORM FOR AFB MICROSCOPY Treatment unit: Date: Name of patient: Age: / / 20 Sex (M/F): Physical address: Area leader/neighbor: Sputum Diagnosis Follow-up Skin smear Month (2, 3, 5, 7/8) TB district number*: Diagnosis Name of person requesting: * Enter the patient’s district TB number for follow-up patients on chemotherapy. Sputum result (to be completed in laboratory) Laboratory serial number: Date Specimen Appearance* Negative Scanty (1–9) + ++ +++ 1 2 3 * Visual appearance (blood stained, muco-purulent, saliva). Examined by (signature): Date: / / 20 / / 20 Skin smear result (to be completed in laboratory) Ear lobe Examined by (signature): Lesion Date: Source: National Department of Health, South Africa; South African National AIDS Council (2010). Clinical Guidelines for the Management of HIV/AIDS in Adults and Adolescents. Page 134
