Download Module 3 Specific Interventions to Prevent Mother-to

Module 3 Specific Interventions to
Prevent Mother- to-Child
Transmission of HIV (PMTCT)
After completing the module, the participant will be able to:
 Describe all essential components of antenatal care (ANC) for a
woman who is HIV-infected.
 Explain the role of antiretroviral drugs (ARVs) in preventing
mother-to-child transmission of HIV (PMTCT).
 Describe strategies for reducing the risks of MTCT during labour
and delivery.
 Discuss the management of women during labour and delivery
who are of unknown HIV status.
 Describe immediate postpartum care of women with HIV
infection.
 Explain the need to integrate family planning into community
services.
 Describe guidelines for immediate newborn care.
UNIT 1
Implementation of Comprehensive ANC Services
After completing the unit, the participant will be able to:
 Describe all essential components of antenatal care (ANC) for a woman who is HIV infected.
Antenatal care
Antenatal care (ANC) is an essential part of quality reproductive health services and
improves the general health and well-being of mothers and their families. Given the rapid
spread of HIV infection worldwide, all pregnant women should be considered at risk for
acquiring HIV infection.
The ANC setting is an important source of health care for women of childbearing age. By
integrating PMTCT services into essential ANC services, healthcare programmes can
improve care—and pregnancy outcomes—for all their clients. This unit addresses the
integration of PMTCT services into ANC for all women, as well as the management of
pregnant HIV-infected women and women of unknown HIV status in ANC programmes.
Antenatal interventions can reduce the risk of MTCT. Good maternal health care helps
women with HIV infection stay healthy longer and care for their children better. When
mothers die prematurely, their children face higher rates of illness and death.
Components of quality ANC and reproductive health relevant to PMTCT
Determining a woman’s HIV status is the first step in providing appropriate treatment,
care and support services. Availability of rapid testing allows women to be tested and
receive their HIV test results at the first prenatal visit. In the context of PMTCT,
components of quality ANC and reproductive health services include (see also Module 2,
Unit 4: Role of Maternal and Child Health Services and Reproductive Health Services for
the Prevention of HIV Infection in Infants and Young Child):
 Comprehensive antenatal services
 Routine HIV testing and counselling
 Counselling on the use of antiretroviral drugs for PMTCT prophylaxis. If the
woman meets eligibility criteria for initiating ARV therapy, she should receive
counselling about that as well.
 Safer infant feeding counselling and support
 Quality intrapartum care that avoids unnecessary invasive procedures and adheres to
infection-prevention practices.
 Quality postpartum care that includes:
 Safer infant feeding counselling and support
 Family planning services
 Comprehensive follow up care for both the HIV-infected mother and her HIVexposed baby
The woman who refuses HIV testing during ANC should be counselled so she has an
opportunity to have her reservations about testing addressed. Where available and
appropriate, she should also be offered couples counselling. Women of unknown HIV
status should be made aware that testing is available at any ANC visit and reminded of
the benefits of knowing their HIV status. If they continue to decline testing, this decision
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must be respected. They should be informed that if they change their mind, or want to
discuss this further, testing and counselling will continue to be available throughout their
pregnancy.
Integrated essential package for ANC services
ANC for women infected with HIV includes the basic services recommended for all
pregnant women. However, obstetric and medical care should be expanded to address the
specific needs of women infected with HIV.
Table 3.1: Integrated essential package for ANC services
Integrated essential package for ANC services
Schedule of ANC visits
Within the first 16 weeks
 First visit
Between 20 and 24 weeks
 Second visit
Between 28 and 32 weeks
 Third visit
From 36 weeks
 Fourth visit
Every pregnant woman should have at least 4 ANC visits. There is no need to increase the number of
antenatal visits for HIV-infected women, unless there are complications. However additional counselling
time may be required.
Determine the following:
Client history
 History of puerperal sepsis, postpartum haemorrhage, infected caesarean
section wound, pre-term labour and delivery, and/or history of abortions
 Past infant-feeding practices; growth and development of the previous child,
history of still birth
 History of HIV Testing and Counselling (HTC, formerly referred to as “VCT”)
and ARV therapy
 History of chronic cough or tuberculosis
 Drug history, known allergies, and use of traditional medicines such as herbal
products.
History of present
Determine the following:
pregnancy
 History and treatment of STIs for woman and partner
 History of significant weight loss
 History of recurrent fever, diarrhoea, and/or cough
Enquire about:
Social history
 Death of children in previous two years and cause of death
 Death of partner and cause of death
 Nature of relationship with partner, e.g., monogamous, polygamous, casual
relationship
Perform full physical exam to assess for current signs or symptoms of illness,
Physical exam and
targeting common symptoms of TB, malaria, anaemia, and sexually transmitted
vital signs
infections (STIs). Assess for/perform the following:
 General appearance
 Height and weight
 Nutritional status (skin fold measurement)
 Anaemia (check sclera and nails, auscultate heart)
 Lymphadenopathy
 Full breast exam
 Full gynaecological exam, speculum and bimanual (inspecting for evidence of
STIs)
 Abdominal exam (checking size of uterus, spleen and liver)
 Intra uterine growth retardation
 Lung sounds (evidence of TB or other respiratory infections)
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Lab tests
STI screening
HIV-related
conditions
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Tuberculosis
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Antimalarials
Immunizations
Integrated essential package for ANC services
Avoid any unnecessary assessment that would potentially rupture a woman’s
membranes.
 Request the following lab tests:
 Haemoglobin to test for anaemia
 Whole blood rapid test for syphilis
 HIV testing if patient did not decline testing
 Urinalysis
 Others according to history and physical exam findings
 Diagnose and treat early according to national protocols, refer if necessary
 Include risk assessment for STIs.
 Counsel about STIs, their signs and symptoms and how STIs increase the risk
of HIV transmission.
 Educate about how to avoid transmission or re-infection.
 Treat according to national guidelines or refer
 Provide prophylaxis based on national protocol.
Co-infection with TB is the leading cause of HIV mortality.
 Prevention and screening
 If pulmonary TB is suspected, refer for registration in national programme and
for sputum collection
Malaria is a major cause of maternal and infant morbidity and mortality rates
and is linked to increased MTCT (via placental infection).
 Administer malaria prophylaxis according to national protocol.
 Immunize according to national guidelines
ARV prophylaxis
and/or therapy:
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Nutritional
assessment,
counselling, and
support
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Health Education
Counselling on
infant feeding
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Determine stage and eligibility for therapy at ARV Clinic
Refer to ARV Clinic if eligible according to national guidelines
If woman is not eligible for ARV therapy, counsel and educate her about use
and benefits of ARV prophylaxis
Include iron and folate supplementation according to national guidelines
Monitor for anaemia, adequate caloric, and nutrient intake.
Counsel about proper diet based on local resources.
Consider providing supplements of protein and energy rich food to high risk
mothers (primigravida, multiple gestation, grandmultipara, women with
anaemia, and those who are malnourished)
De-worm according to national guidelines.
Provide ongoing education about HIV.
Encourage mother to deliver at a health facility
Provide infant-feeding counselling and support.
Key support needs of mothers infected with HIV
Pregnancy is a time of unique stress, and healthcare workers should consider assessing
the amount of support a woman is receiving from family and friends. Both mothers who
are HIV-infected and those who are not HIV-infected need support. However, women
with HIV infection usually have additional concerns related to their own health, their
child’s health, and the possibility that their HIV status may be disclosed to other people.
Providing support to mothers who are infected with HIV will lead to more hope and
acceptance, essential elements for “living positively” (see box).
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Referrals for clients with
HIV and their families may
Living Positively
include the following:
 Food along with
“Living Positively with HIV” refers to living with HIV
nutritional counselling
disease healthily and productively. That is, maintaining
and supplementation
physical, psychological and emotional health. Having
 Practical necessities such dependable sources of counselling and support to health
as clothing and housing
in an effort to lead a happier, more fulfilling life.
 Social and psychological
HIV/AIDS is a major medical condition that must be
support, including
taken seriously, but it is not necessarily a death sentence.
counselling as well as
peer support such as
groups for people living with HIV and groups for mothers.
 Home care, including referrals to community-based health care (CBHC) and
community based distribution (CBD) agents
 Traditional/herbal healers
 Orphan care and support
 Care of children with HIV/AIDS, including growth monitoring
Additional information about linkages and referrals can be found in Module 8.
Preventing HIV-related conditions
Preventing HIV-related conditions can reduce rates of illness and death among pregnant
women who are HIV-infected. It also can reduce the risk of adverse pregnancy outcomes,
such as preterm labour and delivery, which can increase the risk of MTCT.
All women who are infected with HIV and have HIV-related conditions should be treated
according to the treatment guidelines and within the context of the available resources in
Malawi. In situations where such services are not available, a woman should be referred
for appropriate management of the infections to other centres that have the capability.
Women infected with HIV are more susceptible to common infections. Healthcare
workers should pay special attention to signs and symptoms of possible HIV-related
conditions, and follow guidelines for treatment and prophylaxis of common problems
(see Module 7 for additional information). Examples of common conditions that affect
HIV-infected women are
 TB
 Urinary tract infections
 Respiratory tract infections
 Recurrent vaginal candidiasis
 Malaria
 Breast conditions
 Unhealed episiotomies and/or delayed healing of caesarean section wounds
 Herpes zoster
 Puerperal sepsis
Maternal nutrition and mother-to-child transmission
Maternal nutrition during pregnancy and lactation is of considerable importance in
preventing mother-to-child transmission of HIV. A well-nourished woman is likely to be
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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in good health. However, nutritional deficiencies, such as iron and Vitamin A deficiency,
are associated with an increased risk of mother-to-child transmission of HIV. Maternal
malnutrition is also associated with preterm delivery, a factor that significantly increases
the risk of HIV infection in the infant.
Weight gain during pregnancy is an indicator of the mother’s nutritional status. See
Table 3.2 below for recommendations on weight gain in pregnancy.
Table 3.2 Recommended weight gain during pregnancy
Women’s pre-pregnancy weight
Recommended weight gain (kg)
Normal
11.5- 18.0
Underweight
12.5-18.0
Overweight
7.0-11.5
See Appendix 3-A for additional information about maternal nutrition in the context of
HIV.
Exercise 3.1 Antenatal care: case studies

Purpose
Duration
Instructions
To review ANC management in the context of HIV.
25 minutes
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Refer to the ANC case studies below as well as Table 3.1 Integrated
essential package for ANC services.
After reading the first case study, the group can discuss and offer
answers to the questions posed in the case study. Participants can
also respond if they disagree with any of the answers offered.
This process will be repeated for the second case study.
The trainer will ask the group to discuss particular challenging cases
they have experiences in the ANC clinical setting, and how these
challenges were resolved.
Exercise 3.1 Antenatal care: case studies
Case study 1
Nambewe, a 19-year-old single woman, tested HIV-positive at her first antenatal visit.
According to the date of her last menstrual period (LMP), she is approximately
34 weeks pregnant with her first child. She received post-test counselling and was
encouraged to bring her partner in for testing.
According to the above information, what ANC services should Nambewe receive during
the course of her care?
Case study 2
During her first visit to the antenatal clinic, Thoko found out that she was HIV-positive.
When she returned for her second visit, she was “treated badly” by the staff and she left
the clinic. Thoko is now 36 weeks pregnant and although this is her third visit, she has
only seen the nurse once. She asks about the medicine for her and her baby so that the
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baby will not get HIV infection. She also tells you that her partner must not find out that
she is HIV-infected.
What do you tell Thoko?
How was Thoko’s care affected as a result of her second visit?
What other potential obstacles is Thoko facing at home?
What would be your plan of care for Thoko?
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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UNIT 2
Antiretroviral Prophylaxis and Therapy for
PMTCT
After completing the unit, the participant will be able to:
 Explain the role of antiretroviral drugs (ARVs) in preventing mother-to-child
transmission of HIV (PMTCT).
Antiretroviral (ARV) Therapy and ARV Prophylaxis
Antiretroviral drugs are substances that
hinder or inhibit the replication and
mutation of HIV, resulting in less
damage to the immune system by the
virus.
ARV therapy and prophylaxis reduce the
chances of mother-to-child HIV
transmission by decreasing viral
replication in the mother, lowering the
risk of HIV transmission to the infant.
Definitions
ARV therapy: Long-term use of
antiretroviral drugs to treat
maternal HIV/AIDS in order to
improve health and slow the
progression of the disease. ARV
therapy also reduces HIV
transmission from mother to
infant.
ARV therapy during pregnancy
ARV prophylaxis: Short-term
For women diagnosed with HIV during
use of antiretroviral drugs to
pregnancy and eligible for therapy with
reduce HIV transmission from
ARVs, referral to the ARV Clinic should
mother to infant. ARV
be made as soon as possible. ARV
prophylaxis does not treat
drugs are effective for both managing
maternal HIV or provide longHIV infection in the mother and
term protection for the infant.
preventing MTCT. There are a number
of antiretroviral regimens that reduce the
risk of MTCT in both pregnant and breastfeeding women. The choice of when to start
therapy may be delayed until after the first trimester in order to avoid the side effects of
ARV drugs and the risks of taking the drugs during early pregnancy. However, when the
woman is severely ill, the benefits of therapy outweigh any potential risk to the foetus.
Management of pregnant women
receiving ARV therapy
Pregnant women receiving ARV therapy
require ongoing care and monitoring in
both the ANC and ARV Clinics. When coinfection with TB exists, additional drug
therapy and clinical management are
required. The goal is to minimize side
effects, which may occur when ARV drugs
are co-administered with TB therapy, and
to ensure that the ARV regimen does not
contain a drug that interacts with anti-TB
medications.
Any pregnant woman who is taking
ARV therapy should continue therapy
as before. The woman taking ARV
therapy should not be given NVP at
the onset of labour; however, the
newborn should be given NVP as a
single oral dose 2mg/kg within 72
hours of birth. (See Module 7 and
Appendix 3-B for additional
information about ARV therapy.) The
nationally recommended first-line
ARV regimen also can be safely given
to women of childbearing age, who are
HIV-infected and not pregnant.
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Antiretroviral medications for prophylaxis
Since the inception of the PMTCT programme in Malawi in 2001 the predominantly used
ARV prophylaxis has been single dose Nevirapine (sd-NVP) for the mother taken at the
commencement of true labour and sd-NVP for the infant within 72 hours of delivery.
Recently it has been recognized that other regimens given daily during pregnancy and in
combination are more effective in reducing MTCT and emergence of resistance.
However, these regimens are more difficult to administer where infrastructure/access is
an issue.
The HIV/AIDS Unit has phased in the more complex but efficacious WHOrecommended regimen at sites with adequate infrastructure and human capacity for its
delivery. At the same time, expansion of PMTCT to sites with limited infrastructure will
be done using sd-NVP while steps are taken to build their capacity to deliver the
recommended combination regimen. The recommended regimens are listed in Appendix
3-C. See Appendix 3-D for information about the studies supporting the recommended
ARV prophylaxis regimens used in Malawi.
Preventing nevirapine resistance
In order to prevent nevirapine resistance, healthcare workers should avoid providing
multiple doses of NVP to the mother. If the maternal NVP dose is given during false
labour, the dose should not be repeated. The infant should receive the standard dose.
Exercise 3.2 Nevirapine prophylaxis for PMTCT: case studies
Purpose
To help participants understand the use of nevirapine (NVP) for PMTCT.
30 minutes
Duration
Instructions  After reading the first case study, the trainer will guide discussion of
the answer to the case study question, with an opportunity for
participant questions and comments.
 This process will be repeated for the other two case studies.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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Exercise 3.2 Nevirapine prophylaxis for PMTCT: case studies
Case study 1
Baby Sibande was born weighing 2.5 kg. According to the ARV regimen used in your
setting, what drug or drugs should you give him? What dosage of each drug(s) will you
give him?
Case study 2
Susan, a traditional birth attendant (TBA) you know from the community tells you that
she helped deliver a healthy baby to an HIV-infected mother last week. She asks you
whether you can give a medication to prevent HIV-transmission to the newborn. What do
you tell her?
Case study 3
Mwate has come to your health care facility in labour. You only have NVP available at
your clinic. She is given a 200-mg dose of NVP according to the guidelines, but shortly
afterwards her contractions stop. Several hours later you check her condition and realize
that Mwate was in false labour. What should you do about Mwate being given her NVP
prematurely? How does this affect the baby’s dose of NVP ?
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UNIT 3
Optimal Management of Women During Labour
and Delivery
After completing the unit, the participant will be able to:
 Describe strategies for reducing the risks of MTCT during labour and delivery.
 Discuss the management of women during labour and delivery who are of unknown
HIV status.
Care of women during labour and delivery
Most HIV infections that are due to MTCT occur during labour and delivery. It has been
documented that MTCT of HIV can be reduced by using specific interventions during
this time.
Interventions to reduce MTCT during labour and delivery
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Administer ARV therapy or prophylaxis during labour in accordance with guidelines
Use Universal Precautions.
Minimize vaginal examinations.
Avoid prolonged labour.
Avoid routine artificial rupture of membranes.
Avoid unnecessary trauma during delivery.
Avoid routine episiotomy.
Minimize the risk of postpartum haemorrhage.
Use safe transfusion practices
Elective caesarean section is known to reduce MTCT of HIV, but is not a feasible option
in Malawi.
Always use Universal Precautions when providing patient care.
 Observe strict aseptic technique throughout the first stage of labour to prevent
infections.
 Wash hands before and after every procedure.
 Decontaminate the bed, instruments, and linens soon after use.
 Autoclave all instruments used for delivery. Areas without electricity should utilize
high-level disinfection (boiling) following the instructions in the infection prevention
guidelines.
 Use the six swab technique with antiseptic solution for vulval swabbing and vaginal
cleansing, e.g. 0.25% chlorhexidine after excluding contraindications.
 Use protective gear, safely dispose of sharps and contaminated materials, and sterilize
equipment. See Module 9 for additional information.
Minimize vaginal examinations.
 Perform vaginal examinations only when absolutely necessary, using appropriate
sterile technique.
 Record all vaginal examinations on the partograph.
Avoid prolonged labour.
 Use the partograph to monitor the progress of labour.
 Avoid artificial rupture of membranes, unless cervix is at least 6 cm dilated or above.
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In case of spontaneous rupture of membranes when the mother is not in labour,
induce immediately if no contraindications are noted.
If in latent phase of labour, augment, if there are no contraindications.
If in active phase of labour, aim to deliver within 4 hours.
Reinforce pain relief in labour. A woman who is relaxed progresses faster.
Avoid unnecessary trauma and invasive procedures during delivery.
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Avoid unnecessary episiotomy.
Avoid unnecessary trauma to the infant e.g., vigorous suctioning of the airway.
Minimize the use of vacuum extractors.
Prevent genital tract and perineal lacerations.
Do not give enemas.
Do not shave the vulva.
Minimize the risk of postpartum haemorrhage.
 Carefully manage all stages of labour to prevent infection and to avoid prolonged
labour.
 Actively manage the third stage of labour.
Use safe transfusion practices.
 Minimize blood transfusions.
 Use only blood screened for HIV, hepatitis B, and syphilis.
Exercise 3.3 Obstetric practices and HIV: group discussion
To discuss a scenario that will enable participants to exercise their
clinical judgment about safe practices in the labour and delivery
setting.
Purpose
Duration
Instructions
25 minutes
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Participants will be divided into three groups.
Within the small groups, participants will read through the case study
below, discuss the scenario, and make a recommendation in response
to each of the questions.
Participants will reconvene in the large group, and each small group
will be asked to provide their recommendations. In the large group
discussion, alternate answers or strategies may be suggested.
Exercise 3.3 Obstetric practices and HIV: group discussion, case study
You are a midwife in a busy labour and delivery ward. Today you are teaching 3 medical
or midwifery students. A new patient arrives and states that she has been labouring at
home for 5 hours. Her contractions are mild and 8 minutes apart. She tells you that she
tested HIV-positive at an ANC clinic.
1. What are your concerns about performing the initial vaginal exam on this patient?
You assess the patient and she is dilated to 4-5 cm; foetal heart tones are within normal
limits, and the baby’s head is engaged. However, her membranes have not ruptured yet.
You are under pressure from your director to attend to the 4 other labouring women in the
clinic that evening.
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2. Do you rupture her membranes to progress labour?
Four hours go by and a nurse comes to tell you that she has ascultated the baby’s
decelerating heart beat, which did not correspond to a contraction. Upon inspection of the
birth canal, you see that the baby’s head is engaged but that the amniotic sac is still intact.
3. At this point do you rupture her membranes to progress labour?
4. Would you perform an episiotomy now?
Women with unknown HIV status
All pregnant women should be offered an opportunity to receive HIV testing and
counselling as early during the antenatal period as possible, according to the
recommendations outlined in Module 6, “Testing and counselling.” In some situations,
because of the lack of accessible testing services, or because a woman refuses testing, her
HIV status may remain unknown during labour. If a woman presents to the health service
at the time of labour without knowing her HIV status, the national guideline
recommendations for early and late labour are as follows:
 Early labour: Provide information on HIV, test unless the client declines, and provide
women who test HIV-positive and their infants prophylaxis with nevirapine (NVP) as
per national guidelines.
 Late labour (active phase): Defer testing until after delivery and before discharge. At
that time, provide information on HIV infection, test unless the client declines, and,
when appropriate, offer NVP prophylaxis for the infant according to national
guidelines.
 Post-test counselling following delivery, with referral for follow-up services, is
required for all HIV-positive mothers and their infants.
Pre-test information checklist for use in labour and delivery
 HIV is the virus that causes AIDS.
 HIV can be transmitted from a mother to her infant during pregnancy, labour and
delivery, and breastfeeding.
 Rapid HIV testing can help determine a client’s HIV status and the need for
further interventions and care.
 A positive rapid HIV test result must be confirmed with a second test.
 It is strongly recommended that the client know her HIV status in order to protect
her baby.
 Medicines are available to reduce the risk of passing HIV infection from a
mother to her baby.
 All woman will be provided with appropriate labour and delivery care services,
regardless of her decision about HIV testing and test results.
Women and their infants should not be provided with prophylaxis unless the mother
has been tested for HIV infection and found to be HIV- positive.
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Exercise 3.4 HIV testing and ARV prophylaxis during labour and delivery:
case studies
To understand the use of ARV prophylaxis of MTCT in various
scenarios
Purpose
Duration
35 minutes
Instructions
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
Participants will be divided into four groups and assigned to one of
the case studies below.
Each group can use the next 15 minutes to answer and record the
answers to the case study questions. These answers will be presented
to the large group for further discussion.
Exercise 3.4 HIV testing and ARV prophylaxis during labour and delivery:
case studies, case studies
Case study 1
Doreen has arrived at the hospital to have her baby. She tells you that she has a
passport from Lilongwe Central Hospital, but in her rush to get to the hospital, she
left her passport at home. You would like to ask Doreen if she has been tested for
HIV, but the room is crowded and you do not want to discuss this in front of others.
Doreen is in early labour and contractions are now regular.
How can you find out whether Doreen has been tested for HIV?
If you determine that Doreen was tested and is HIV-infected, what will be your next
step?
Case study 2
Nabanda gave birth yesterday to a beautiful baby girl at home with a traditional birth
attendant (TBA). This was her fourth child and the baby was delivered within an hour of
the start of her first contraction. Nabanda never had the opportunity to take the
nevirapine tablet that had been given to her at the clinic.
When Nabanda asks if she should take the tablet now, what do you tell her?
When should her dose of NVP (200 mg) have been taken?
What about the nevirapine syrup for the baby — when should she give this to her new
daughter?
Nabanda asks you “Will my little girl still be protected from HIV?” What will you
tell her?
Case study 3
Theresa arrives in labour and delivery. She has received no antenatal care and has
never been tested for HIV. At this time, she is in advanced labour with contractions
about 2 minutes apart. On examination you find she is 7 centimetres dilated. She
asks you about HIV testing, and says that she is worried that she could be infected
and pass HIV on to her baby.
Will you provide HIV testing right now?
What can you tell her about protecting her baby after delivery?
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Case study 4
Supuni arrives at the labour and delivery ward at 40 weeks gestation. She presents
you with her ANC passport, which states she is infected with HIV and has been
taking d4T/3TC/NVP (Triomune) for one year. She started labour one hour ago and
this is her first child.
Do you need to test her for HIV?
What else do you want to know about this patient?
Do you administer short-term prophylaxis to the patient? If so, with which ARV(s)?
Do you administer short-term prophylaxis to the infant?
What procedures do you want to avoid in the delivery process?
What additional counselling does the patient need?
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UNIT 4
Postpartum Management of Women and Infants
After completing the unit, the participant will be able to:
 Describe immediate postpartum care of women with HIV infection.
 Explain the need to integrate family planning into community services.
 Describe guidelines for immediate newborn care.
Immediate and subsequent postpartum care of HIV-infected mothers
The following is a listing of services that should be offered to HIV-infected women after
delivery, before discharge, and upon discharge.
Provide

Assess Mother
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Offer
education,
counselling,
and support*
Provide
referrals for
Immediately After Delivery
ARV prophylaxis to the infant
Before Discharge
Personal hygiene
Nutritional status
Routine Vitamin A and iron supplement to the mother
Signs and symptoms of anaemia and infections
Signs of uterine involution
Breast conditions
Urinary tract infections
Episiotomies, caesarean section
Signs of PID and any other infections
Clinical features of HIV or AIDS
Possible side effects of ARVs
Infant feeding (See Module 4, Infant Feeding in the Context of
HIV Infection.)
 Infant re-hydration in the case of diarrhoea
 Infant’s umbilicus care
 Infant hygiene: changing diapers and washing the infant
 Diet and nutrition, particularly during lactation
 Recognizing signs and symptoms of:
 Postpartum infection
 Anaemia
 Infant illness
 Accessing help in the event of postpartum haemorrhage
 Information on breast and urinary tract infections
*It may be necessary to include an adult family member (parent or
aunt) when counselling the unmarried client younger than 16 years of
age and women with special needs.
Grandmothers or other guardians and relatives should be encouraged
to attend postpartum counselling sessions.
 Postpartum haemorrhage
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Malawi PMTCT Participant Manual
Offer
education,
counselling
and support*
Link patients
to centres that
provide the
following
services
Ongoing Postpartum Care
 Follow-up care: both routine (one-week and six-week visits, then
monthly check ups) and as needed
 Family planning information and services, including information
on condom use for dual protection (See below.)
*It may be necessary to include an adult family member (parent or
aunt) when counselling the unmarried client younger than 16 years of
age and women with special needs
 Postnatal review, including date for one-week and six-week visits
 Immunizations
 “Under-five” services
 Infant-feeding support
 Sexual and reproductive health care, including family planning
 Prevention and treatment of HIV-related conditions
 Prevention and treatment of malaria
 Nutritional counselling and support
 Support groups available in the community
 HIV treatment, care, and support (ARV Clinic), if eligible (see
Appendix 3-E and 3-F for adult and child ARV therapy eligibility
criteria)
 Social and psychosocial support
 Home-based care
 Services for any other health concern for the mother or her infant
All services should be provided according to infection prevention guidelines.
Family planning in the context of HIV
Family Planning (FP) is part of a comprehensive public health strategy to prevent MTCT.
Ideally, this should begin prior to a first pregnancy. A range of family-planning services,
when integrated into existing ANC and community health services, can minimize the
stigma associated with HIV/AIDS and provide:
 Individual and couples counselling
 Continued risk assessment
 Early diagnosis and treatment of STIs including HIV/AIDS
 Information about and the skills needed to practise safer sex
 Access to contraceptives
Family Planning methods should be discussed before and soon after delivery with access
to the chosen method within 6 weeks after delivery to avoid unintended pregnancy or risk
of new infection. Emphasize use of dual protection, i.e. the use of condoms to prevent
STDs and unplanned pregnancy.
Breastfeeding mothers
 Combined oral contraceptives, that contain estrogen, can decrease breastmilk
production.
 Progesterone-only contraceptives should be started 6 weeks postpartum or later for
the breastfeeding mother.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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Immediate and subsequent postnatal care of the newborn
The immediate care of the newborn exposed to HIV follows standard practice.
Regardless of the mother’s HIV status, all infants are kept warm after birth and are
handled with gloves until maternal blood and secretions have been washed off.
Other practices to ensure infant safety:
 Clamp cord immediately after birth, and avoid milking the cord. Cover the cord with
gloved hand or gauze before cutting to avoid splash of cord blood.
 Wipe infant’s mouth and nostrils with wet gauze or towel as soon as the head is
delivered.
 Use suction only when meconium-stained liquid is present. Use either mechanical
suction at less than 100 mm Hg pressure or bulb suction, rather than mouth-operation
suction.
 Reduce exposure to maternal blood and secretions by wiping the infant dry with a
towel.
 Keep the baby warm – skin to skin contact
 Determine the mother’s feeding choice:
 If she is using a breastmilk substitute, place the infant on her body for skin-to-skin
contact and provide help with the first feeding.
 If she is breastfeeding, place the infant on the mother’s breast within 30 minutes
of birth. Assess for effective sucking.
 Assess general condition:
 Bleeding
 Presence of infections, especially of the eyes
 Birth defects / Congenital malformations or abnormalities
 Calculate APGAR score
 Administer tetracycline eye ointment according to national guidelines.
 Avoid invasive resuscitation procedures
 Observe infection prevention measures
Subsequent newborn care for infants exposed to HIV
Make assessments and implement preventive measures:



Infant feeding – Breastfeeding or replacement feeding
Administer antiretroviral drugs within 72 hours as specified in the PMTCT guidelines
Immunization according to EPI schedule
All infants born to HIV-infected women should receive NVP prophylaxis as soon as
possible but within 72 hours of birth. If given after 72 hours of birth, NVP is not
effective in preventing MTCT. Infants born at home should be brought into the health
facility for prophylaxis within 72 hours of birth.
HIV Testing
HIV testing is an important component of care for HIV-exposed infants. See Module 6:
Testing and Counselling for information on testing of HIV-exposed infants and Module
7: Comprehensive Care and Support for Mothers and Families with HIV Infection, for
detailed information on signs and symptoms of HIV infection.
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Ongoing follow-up and preventive therapies for HIV-exposed infants, such as
Cotrimoxazole Preventive Therapy (CPT), will also be discussed in Module 7.
Linkage of mother and infant to community services
The MCH and Reproductive Health services play a key role in linking women with HIV
and their families to the continuum of care. These linkages and referrals between ANC
and maternity are essential to increase the rates of postpartum follow-up, which are
currently very low. Efforts to increase uptake of postpartum care will require a multiagency response:
 Provide education during ANC on the availability of service that the woman will need
after the baby is born (adult and infant and young child services)
 Implement family-centred care whereby the mother and baby receive their routine
follow-up care at the same venue during the same visit
See Module 8 for additional information about postpartum follow-up care.
Exercise 3.5 Supporting postpartum follow-up: group discussion
Purpose
To explore strategies to support women during postpartum follow-up.
Duration
Instructions
25 minutes
In a trainer-led discussion, participants will examine the following
questions:
 What are the biggest challenges to postpartum follow-up in their
communities?
 What are some ways to increase the uptake of postpartum services?
 What suggestion do you have for improving postpartum follow-up for
women who deliver at home?
 Are there key community agencies or groups that might be able to
help bridge this gap between MCH and RH services?
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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Module 3: Key Points









The essential package of ANC services includes the basic services recommended for
all pregnant women, including HIV testing. However, for women with HIV, obstetric
and medical care should be expanded to address the specific needs of women infected
with HIV.
Nutritional assessment, counselling and support are important not only in the
antenatal period when good nutrition plays a role in foetal health and PMTCT, but
also in the postpartum period, particularly for the breastfeeding mother and for the
HIV-exposed or HIV-infected infant and young child.
ARV therapy is the long-term use of antiretroviral drugs to manage maternal HIV and
prevent MTCT; ARV prophylaxis is the short-term use of antiretroviral drugs to
reduce MTCT of HIV.
The HIV/AIDS Unit has phased in the more complex but efficacious WHOrecommended regimen (which include AZT, NVP and, in some instances, 3TC) at
sites with adequate infrastructure and human capacity for its delivery. At the same
time, expansion of PMTCT to sites with limited infrastructure will be done using
single dose Nevirapine (sd-NVP) while steps are taken to build their capacity to
deliver the recommended combination regimen.
The infant ARV prophylaxis regimen is either AZT alone, NVP alone or a
combination of AZT and NVP. ARVs should be initiated to the infant as soon as
possible after birth but within 72 hours of delivery.
Using safer obstetrical practices can reduce MTCT of HIV in labour and delivery.
There are national recommendations for testing of women of unknown HIV status in
early labour and soon after delivery.
Support for safer infant-feeding practices are a priority in the immediate postpartum
period.
Establishing linkages for postpartum follow-up of mother and infant can improve
uptake of treatment and support services and reduce HIV-related morbidity and
mortality.
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APPENDIX 3-A Maternal Nutrition in the Context of HIV
A well-nourished woman is likely to be in good health. Consequently she is able to look
after the family well. When she is pregnant, the outcome of her pregnancy is likely to be
favourable and her lactation performance is enhanced.
Maternal malnutrition is also associated with preterm delivery, a factor that significantly
increases the risk of HIV infection in the infant. Therefore, maternal nutrition during
pregnancy and lactation is of considerable importance in preventing mother-to-child
transmission of HIV.
Promotion of good maternal nutrition
The essential components of a good diet are
 Protein
 Energy
 Minerals
 Micronutrients
These nutrient requirements are essential to maintain
 Basal metabolic rate
 Physical activity
 Growth
The nutritional requirements differ during various stages of a girl's life.
 Girl-child: This is a stage of rapid growth and, therefore, the requirements for all
nutrients increase.
 Adolescent: This stage is characterized by a growth spurt and onset of maturation.
Nutritional demands are high.
 Non-pregnant, non-lactating woman: Requirements for iron are ongoing to replace
monthly loss during menstruation.
 Pregnant woman: During a normal pregnancy, a woman gains 10 to 12 kg. This
weight includes the baby, placenta, amniotic fluid, and subcutaneous fat.
 Lactating women: Breastfeeding is a demanding process. Women require the
equivalent of a whole extra meal per day to accommodate lactation. If nutritional
intake during pregnancy and lactation is inadequate, foetal growth and milk
production may be at risk.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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APPENDIX 3-A Maternal Nutrition in the Context of HIV (continued)
Factors affecting maternal nutrition
Beliefs and culture
Different cultures have different belief systems about foods that pregnant and lactating
women should eat. Often, nutritious protein-rich foods are excluded from the diet e.g.
eggs. Familiarize yourself with the foods that may be taboo in the community you serve
in order to be able to address them during health education and counselling.
Heavy workload
A women’s heavy workload requires energy and calories. If a woman’s diet is only
marginally nutritious, the competing needs of physical work and pregnancy contribute
significantly to nutritional depletion and increased risk of delivering a low-birth-weight
infant.
Alcohol
Alcohol intake during pregnancy may lead to higher rates of spontaneous abortion and
low-birthweight. Babies may be born with abnormalities of the eyes, nose, heart
including growth and mental retardation, also known as foetal alcohol syndrome,
Tobacco
Smoking doubles the risk of low birthweight including the following serious pregnancy
complications.
 Bleeding during pregnancy (antenatal haemorrhage)
 Premature rupture of membranes
 Preterm delivery
Indicators of adequate nutrition



Infant birthweight: Maternal nutrition during pregnancy and lactation is often
discussed from the point of view of infant birthweight.
Mother’s height and weight: Height is a measure of skeletal growth. Taller women
have heavier babies than do shorter women. Short stature is often the result of
chronic food shortage during childhood. The likelihood of having a contracted pelvis
is greater in short women and with it comes a higher risk of obstructed labour,
requiring operative delivery.
Body mass index: Body mass index (BMI) is a composite measure of weight and
height (BMI=Weight in kilograms divided by height2 in metres). For example, a
woman who is 1.6 metres tall and weighs 55 kgs has a BMI of 55 divided by the
square of 1.6 that gives BMI of 21.5. BMI is a reasonable indicator of current
nutritional status. Women with a BMI less than 18 are classified as being severely
energy depleted, 18 to 21 as moderately depleted, while over 21 is considered to be a
reflection of adequate nutritional status. BMI changes considerately during
pregnancy; however, it is a useful measure of nutritional status during lactation and in
the non-pregnant state.
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Malawi PMTCT Participant Manual
APPENDIX 3-A Maternal Nutrition in the Context of HIV (continued)


Mid-upper-arm-circumference: The mid-upper-arm circumference (MUAC) is
measured using a non-stretch tape on the left arm. MUAC does not change
appreciably during pregnancy. MUAC is a good measure of the body’s muscle mass
and therefore a good indicator of body protein.
Weight gain during pregnancy: is an indicator of the mother’s nutritional status during
pregnancy. The weight gain is due to the products of conception and maternal fat
stores. The fat stores laid down during pregnancy are used as a source of energy
during periods of rapid foetal growth in late pregnancy and energy for labour and
lactation. The table below outlines the distribution of weight gain during pregnancy.
Product
Weight (kg)
Foetus
3.0
Placenta
0.4
Amniotic fluid
0.8
Uterus (weight increase)
1.1
Breast tissue (weight increase)
1.4
Blood volume (weight increase)
1.8
Maternal fat store
1.8-3.6
TOTAL
10-13.9
Recommended weight gain during pregnancy
During pregnancy nutritional status can be monitored by the rate of weight gain. In the
first trimester a woman should gain 1 to 3 kg. Thereafter the weight gain should be
approximately 1 kg a week for the remainder of the pregnancy. A higher weight gain is
not normal and is associated with complications such as pre-eclampsia and gestational
diabetes.
Consequences of micronutrient deficiencies
In a Tanzanian study, HIV-infected and HIV-negative women were randomized to
receive a multivitamin supplement containing Vitamins B1, B2, B6, niacin, B12, C, and
E, folic acid, and iron and folate alone. The micronutrient supplement that included the B
Vitamins significantly reduced the incidence of foetal deaths, low birthweight, preterm
delivery before 34 weeks and small-for-gestational age babies. The additional benefit for
HIV-infected women was reduced transmission in subgroups of women who were
nutritionally or immunologically compromised. Overall, women taking multivitamin
supplementation had significantly elevated CD4, CD8 and CD3 lymphocyte counts.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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APPENDIX 3-A Maternal Nutrition in the Context of HIV (continued)
Micronutrients deficiencies have a direct impact on the health of pregnant women,
including HIV-infected women. Anaemia increases the likelihood that a woman will
transmit HIV infection to her infant. Anaemic pregnant women also may require a blood
transfusion, thus putting them at risk of HIV infection. The most common nutritional
anaemias are deficiencies of iron, folic acid, and vitamin B12. Therefore, preventing
anaemia is important for the health of both HIV- and uninfected women.
Iron
The consequences of iron-deficiency anaemia can be classified into maternal and foetal
outcomes.
 Maternal outcomes include heavy bleeding (haemorrhage) during pregnancy and
delivery and puerperal infections.
 Foetal outcomes include prematurity and low birthweight. Preterm babies are at
higher risk of acquiring HIV infection from their mothers.
Vitamin intake during pregnancy
Adequate vitamin intake during pregnancy of B Vitamins (thiamine, niacin and
riboflavin) folic acid, B12, Vitamins C, A, D, E, and K are essential. We will only
consider a few selected vitamins in this section.
Folic acid
Folic acid is essential for synthesizing RNA, an important component of cell cytoplasm,
and of DNA, the key component of the cell nucleus. Folic acid is also critical for
manufacturing non-essential amino acids. Malaria and sickle-cell anaemia increase a
women’s need for folic acid.
Vitamin A
Vitamin A plays an important role in maintaining the integrity of epithelial surfaces such
as the skin and mucus membranes. Vitamin A is essential for normal immune responses.
However, not enough is known about vitamin A during pregnancy and it should not be
taken in large doses. Maternal supplementation with vitamin A is associated with:
 Reduced prevalence of anaemia
 Reduced maternal mortality
 Increased survival of HIV-infected women and children
Vitamin A deficiency is associated with
 Mother-to-child-transmission of HIV
 Higher concentrations of HIV-1 virus in breastmilk of immuno-suppressed women.
 Impaired vision with the earliest symptom being night blindness
 Increased mortality
Supplementing the diet of HIV-negative women with vitamin A reduces mortality.
Similarly, Vitamin A supplementation reduces mortality of HIV-negative and HIVnegative children. New research findings now show that high doses of Vitamin A
supplementation may increase breastmilk transmission of HIV and therefore low-dose
supplementation should be maintained during the period of lactation.
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APPENDIX 3-A Maternal Nutrition in the Context of HIV (continued)
Factors contributing to nutritional impairment in the HIV-infected
mother
Four factors have been implicated in nutritional impairment in HIV-infected persons.
Poor energy intake
 Some HIV-infected persons are unable to eat adequate amounts of food, and therefore
they do not receive the nutrients they require. Several conditions may make it
difficult to eat enough:
 Oral lesions: infection with candida, herpes simplex virus and/or cytomegalovirus
 Gastric irritation, nausea, or vomiting caused by HIV and its co- morbidities or
ARV drugs can lead to a loss of appetite and reduced nutritional intake.
 Primary anorexia may lead to reduced nutrient intake.
Gastrointestinal tract absorption
 GI tract absorption may be impaired in an HIV-infected person because of primary
HIV infection of the epithelium. This can also occur with other pathogens like
bacterial, protozoan, fungal and viral agents that affect the gut.
Energy use
 During infection, including HIV infection, the basal metabolic rate increases and a
higher caloric intake is needed to sustain normal metabolism.
Social and psychosocial status
 Financial constraints resulting from loss of employment or increased health
expenditure limit family resources that are available to ensure a varied and nutritious
diet for the sick person and other family members.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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APPENDIX 3-B Mechanism of Action, Side Effects, and General
Management Principles of ARV Therapy
Types of anti-retroviral drugs and their mechanism of action
There are two major classes of ARVs based on their mechanism of action: Reverse
Transcriptase Inhibitors (RTIs) and protease Inhibitors (PIs)
Class of ARV
RTIs
Description
These drugs non competitively inhibit the
enzyme called reverse transcriptase which
enables the HIV genetic material to convert
into body genetic material, DNA, by
binding to a site distant from the enzyme’s
active site
Reverse transcriptase inhibitors are further
divided into 3 groups
 Nucleoside reverse transcriptase
inhibitors (NsRTIs)


Protease
Inhibitors
(PIs)
Examples
Nucleotide reverse transcriptase
inhibitors (NtRTIs)
Non –nucleoside reverse transcriptase
inhibitors (NNRTIs)
Protease is an enzyme of the HIV virus that
speeds up the assembly of core viral
components (proteins) into independent
viruses. Protease inhibitors inhibit the
action of this viral enzyme leading to
production of immature and non-infectious
virus particles.
Examples of NsRTIs include:
 Zidovudine (AZT)(ZDV)
 Didanosine (ddI)
 Stavudine (d4T)
 Lamivudine (3TC)
 Zalcitibine (ddC)
 Abacavir (ABC)
 Example of NtRTIs:
 Tenofovir (TDF)
Examples of NNRTIs include:
 Nevirapine
 Delavirdine
 Efavirenz
Examples of PIs include:
 Saquinavir (SQV)
 Ritonavir (RTV)
 Indinavir (IDV)
 Nelfinavir (NFV)
 Amprenavir (APV)
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APPENDIX 3-B Mechanism of Action, Side Effects and General
Management Principles of ARV Therapy (continued)
Types of ARV therapy used in Malawi
Monotherapy
This is the use of one antiretroviral drug. Monotherapy is no longer recommended for
use in the treatment of HIV infection. However, a single drug can be used in the
prevention of mother-to-child transmission of HIV where zidovudine (AZT) or
nevirapine (NVP) are used.
Combination therapy
Combination therapy is the use of more than one antiretroviral drug. The current
standard of care for ARV therapy involves using a combination of three ARV drugs,
sometimes referred to highly active antiretroviral therapy (HAART). It has been
demonstrated that using ARV drugs in combination with one another is more effective at
reducing the viral load and has less of a chance of the HIV virus mutating and developing
resistance. The current recommendation in Malawi for first line ARV therapy is the use
of a three-drug combination of lamivudine, stavudine and nevirapine, which is also
known by the name of its fixed-dose combination, Triomune.
Rationale for using ARV therapy for PMTCT
 It will reduce the number of HIV infected infants and thus also reduce the burden they
impact on time commitment, energy, and resource for the caretakers.
 It will reduce the cost of caring for an HIV positive infant to the health care system
and family structure.
 ARV therapy for PMTCT saves children’s lives.
Mechanism of action
ARV drugs, in the NRTI class, act by specifically targeting and hindering functions of the
enzyme reverse transcriptase. This enzyme is responsible for converting the viral protein
(RNA) to the human type of genetic material (DNA). The enzyme helps the HIV virus
reproduce itself.
 The use of these drugs during pregnancy and delivery has been shown to be effective
in reducing the transmission of HIV from mother to infant because they reduce the
amount of HIV virus in a mother’s body.
 These drugs are
 Rapidly absorbed after oral dosing
 Transferred across the placenta to the infant and are therefore effective in
preventing MTCT
See Appendix 7-C and 7-D for a listing of side effects and management of some common
ARV drugs used in Malawi.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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APPENDIX 3-B Mechanism of Action, Side Effects and General
Management Principles of ARV Therapy (continued)
Basic principles for combined ARV therapy during pregnancy
 ARV therapy should not be withheld during pregnancy unless there are known
adverse effects for the mother, foetus or infant, which outweigh the potential benefits.
 All women should be counselled on the risks and benefits of ARV therapy for the
mother, for the HIV-exposed or infected infant.
 AZT and nevirapine have no known teratogenicity, however, the risk of teratogenicity
is known for some of the other ARVs e.g., efavirenz (EFZ) an NNRTI.
 Efavirenz (EFV) which is used as a substitute for NVP if patients have liver disease
according to the national ARV therapy guidelines should not be used by women who
may become pregnant because of the risk of birth defects. It can however be used
after the first trimester of pregnancy.
 AZT and d4T should not be given at the same time.
 If the ARV therapy regimen does not include AZT, this drug should be added or
substituted, but it should not be added to d4T.
 Like most medications, all ARV drugs have side effects which should be managed.
For more information on the types of side effects of commonly used ARV drugs in
Malawi, see Appendix 7-C. For more information on how to manage common side
effects see Appendix 7-D.
 A full blood count is an important baseline test to perform before starting ARV
therapy with AZT. AZT should not be started if a women’s haemoglobin level is
below 8.0 g/dl.
 Where possible liver functions tests (LFTs) may be done as a baseline and repeated as
indicated if there are abnormal results or clinical indications.
 Where available, CD4 cell counts and viral load testing may be done before ARV
drugs are administered. These lab measurements can be used to monitor patients
every 3 to 4 months when available.
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APPENDIX 3-C National Antiretroviral (ARV) Regimens for PMTCT
Single drug ARV prophylaxis administration during labour and
delivery and postpartum
PREGNANCY
LABOUR
POSTPARTUM
Infant
Mother
No ARVs during
pregnancy
Single dose NVP
200mg at onset of
labour1
None
1.
Single dose NVP 6mg
Combination ARV prophylaxis administration during labour and
delivery and postpartum
PREGNANCY
LABOUR
POSTPARTUM
Infant
Mother
1. AZT 300mg
twice a day from
28 weeks gestation
to onset of labour2
2. No ARVs
during pregnancy
3. Women on ART
4. No ARVs
during pregnancy
1
2
1. Single dose NVP
200mg at onset of
labour
2. AZT 600mg at
onset of labour or
300mg every 3hrs
until delivery but
not more than
1500mg.
1. Single dose NVP
200mg at onset of
labour
2. AZT 600mg at
onset of labour or
300mg every 3hrs
until delivery but
not more than
1500mg.
For all women that
qualify based on
clinical staging and
or CD4 and the
dosage should
continue during
labour or just before
caesarean section.
No ARVs during
labour
AZT/3TC 300mg
twice daily for 7
days
1.
2.
3.
AZT 300mg twice
daily for 7 days
1.
2.
3.
Single dose NVP (6mg)
AZT 4mg/kg twice daily for 7
days (NB: low birth babies <2.5
kg will receive 2mg/kg)
Babies delivered at home should
get AZT within 72 hours from the
health facility
Single dose NVP (6mg)
AZT 4mg/kg twice daily for 7
days (NB: low birth babies <2.5
kg will receive 2mg/kg)
Babies delivered at home should
get AZT within 72 hours from the
health facility
Should continue
ART postpartum
1.
AZT 4mg/kg twice daily for 7
days (NB: low birth babies <2.5
kg will receive 2mg/kg)
None
1.
2.
Single dose NVP 6mg
AZT 4mg/kg twice daily for 4
weeks (NB: low birth babies <2.5
kg will receive 2mg/kg)
A single dose NVP regimen is inexpensive and effective. It can be used for women who do not attend
ANC clinics and for women who present in early labour. The risk of side effects from NVP is very
low when used as a single dose. NVP is not teratogenic, it will not harm a foetus.
The AZT regimen can be started as early as 14 weeks if a women presents for ANC care early. Most
PMTCT services in Malawi will start the AZT regimen between 34 and 36 weeks. A baseline
haemoglobin should exclude anaemia before starting this prophylaxis regimen. The risks of side
effects from short term AZT is very low. AZT is not teratogenic, it will not harm a foetus.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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APPENDIX 3-C National Antiretroviral (ARV) Regimens for PMTCT
(continued)
General information on ARV drugs used in prophylaxis regimens
Zidovudine
(ZDV, AZT)


Absorbed quickly after being taken by mouth.
Prenatal and neonatal exposure to ZDV is generally well tolerated.
Nevirapine
(NVP)





Absorbed quickly after being taken by mouth.
Crosses the placenta quickly to protect the infant
Long half-life benefits the infant
May be taken with or without food
Can be given as a single dose for mother and a single dose for the
infant if no other ARV drugs are available for PMTCT.
See Appendix 7-C for Recommended Food Intake and Side Effects of NVP and AZT.
Single-dose nevirapine prophylaxis has the following disadvantages:
 NVP prophylaxis does not protect the infant against HIV transmission outside of the
immediate postpartum period if breastfeeding.
 HIV may become resistant to nevirapine, when it is used alone as prophylaxis to
prevent MTCT.
Viral resistance
HIV can develop resistance when there are not enough ARV drugs in the body. The virus
mutates or changes so that an ARV drugs is no longer effective. This can occur when a
person on ARV therapy, particularly if they:


Regularly skips doses of their ARV drugs
Take another medication that interacts with ARVs by lowering the amount of ARV
drugs in the body.
Resistance can also develop when a single dose of NVP is given during labour to prevent
MTCT. The clinical significance of this under investigation but it appears that when a
woman is given single dose NVP to prevent MTCT and is later given a HAART regimen
that contains NVP, the regimen may not work to reduce her viral load. However,
resistance to NVP has been shown to diminish over time. When a pregnant woman was
given single dose NVP to prevent MTCT during a second pregnancy, the drug was still
effective in preventing MTCT.
Single-dose NVP is still effective in preventing MTCT but its use may decrease the
number of drugs available to treat a women’s HIV infection in the future. This is
especially important as NVP is used in the first line regimen in Malawi.
Preventing nevirapine resistance
In order to prevent nevirapine resistance, healthcare workers should avoid providing
multiple doses of NVP to the mother unless it is necessary. If the maternal NVP dose is
given during false labour, the dose should not be repeated. The infant should receive the
standard dose.
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APPENDIX 3-D Studies Supporting the National ARV Prophylaxis
Regimens
In support of using the AZT regimen
Abstract:
Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a
randomized controlled trial. Bangkok Collaborative Perinatal HIV Transmission
Study Group. Authors: Shaffer N, Chuachoowong R, Mock PA, Bhadrakom C,
Siriwasin W, Young NL, Chotpitayasunondh T, Chearskul S, Roongpisuthipong A,
Chinayon P, Karon J, Mastro TD, Simonds RJ.
BACKGROUND: Many developing countries have not implemented the AIDS Clinical
Trials Group 076 zidovudine regimen for prevention of perinatal HIV-1 transmission
because of its complexity and cost. We investigated the safety and efficacy of shortcourse oral zidovudine administered during late pregnancy and labour.
METHODS: In a randomized, double-blind, placebo-controlled trial, HIV-1-infected
pregnant women at two Bangkok hospitals were randomly assigned placebo or one
zidovudine 300 mg tablet twice daily from 36 weeks' gestation and every 3 h from onset of
labour until delivery. Mothers were given infant formula and asked not to breastfeed. The
main endpoint was babies' HIV-1-infection status, tested with HIV-1-DNA PCR at birth,
2 months, and 6 months. We measured maternal plasma viral concentrations by RNA
PCR.
FINDINGS: Between May, 1996, and December, 1997, 397 women were randomized;
393 gave birth to 395 live-born babies. Median duration of antenatal treatment was 25
days, and median number of doses during labour was three. 99% of women took at least
90% of scheduled antenatal doses. Adverse events were similar in the study groups. Of
392 babies with at least one PCR test, 55 tested positive: 18 in the zidovudine group and
37 in the placebo group. The estimated transmission risks were 9.4% (95% CI 5.2-13.5)
on zidovudine and 18.9% (13.2-24.2) on placebo (p=0.006; efficacy 50.1% [15.4-70.6]).
Between enrolment and delivery, women in the zidovudine group had a mean decrease in
viral load of 0.56 log. About 80% of the treatment effect was explained by lowered
maternal viral concentrations at delivery.
INTERPRETATION: A short course of twice-daily oral zidovudine was safe and well
tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child
HIV-1 transmission by half. This regimen could prevent many HIV-1 infections during
late pregnancy and labour in less-developed countries unable to implement the full 076
regimen.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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APPENDIX 3-D Studies Supporting the National ARV Prophylaxis
Regimens (continued)
In support of using single dose NVP regimen
Abstract:
Intrapartum and neonatal single-dose nevirapine compared with zidovudine for
prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET
012 randomized trial. Authors: Guay LA, Musoke P, Fleming T, Bagenda D, Allen M,
Nakabiito C, Sherman J, Bakaki P, Ducar C, Deseyve M, Emel L, Mirochnick M, Fowler
MG, Mofenson L, Miotti P, Dransfield K, Bray D, Mmiro F, Jackson JB.
BACKGROUND: The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis
regimen for HIV-1-infected pregnant women and their babies has been associated with a
significant decrease in vertical HIV-1 transmission in non-breastfeeding women in
developed countries. We compared the safety and efficacy of short-course nevirapine or
zidovudine during labour and the first week of life.
METHODS: From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected
pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned
mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of
birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h
until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested
babies for HIV-1 infection at birth, 6-8 weeks, and 14-16 weeks by HIV-1 RNA PCR.
We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis.
FINDINGS: Nearly all babies (98.8%) were breastfed, and 95.6% were still
breastfeeding at age 14-16 weeks. The estimated risks of HIV-1 transmission in the
zidovudine and nevirapine groups were: 10.4% and 8.2% at birth (p=0.354); 21.3% and
11.9% by age 6-8 weeks (p=0.0027); and 25.1% and 13.1% by age 14-16 weeks
(p=0.0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 2064) up to age 14-16 weeks. The two regimens were well tolerated and adverse events
were similar in the two groups.
INTERPRETATION: Nevirapine lowered the risk of HIV-1 transmission during the
first 14-16 weeks of life by nearly 50% in a breastfeeding population. This simple and
inexpensive regimen could decrease mother-to-child HIV-1 transmission in lessdeveloped countries.
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APPENDIX 3-E Eligibility for ARV Therapy, Adults (aged 15 years
and older)
Adult patients will be eligible for ARV therapy if they fulfil condition 1 and 2 PLUS
either conditions 3, 4, 5, or 6 (See also national ARV guidelines).
Condition
1. Patients are known
to be HIV-seropositive
Description of Condition


2. Patients understand
the implications of
ARV therapy


3. Patients are assessed
as being in WHO
Clinical Stage 3



4. Patients are assessed
as being in WHO
Clinical Stage 4
5. Patients are assessed
as being in WHO
Clinical Stage 2 with a
total lymphocyte count
< 1200/mm3
6. Patients have a CD4
lymphocyte below
250/mm3

Patients must have undergone HIV testing and counselling, and must
provide written evidence of a positive HIV-test result from a reputable and
quality assured HIV testing and counselling (HTC) site.
Patients who provide verbal confirmation only of a positive HIV-test result
are not eligible for ARV therapy.
Patients must have undergone counselling sessions (group and individual)
during which the implications of ARV therapy have been discussed, in
particular that ARV therapy requires high adherence and compliance and
is a life long commitment.
Patients who are ill with an opportunistic infection or HIV-related
malignancy should be treated appropriately and stabilized before
considering the possible use of ARV therapy. ARV therapy is not an
emergency treatment.
Patients who have any of the features listed in Stage 3 should receive ARV
therapy, but be stabilized before treatment commences.
There must be documented written evidence of a history of
a) pulmonary tuberculosis within the past year or
b) severe bacterial infections.
Verbal reports of pulmonary TB or bacterial infections will not be
acceptable as evidence for starting ARV therapy.
Patients who have any of the features listed in Stage 4 should receive ARV
therapy, but be stabilized before treatment commences.

A total lymphocyte count < 1200/ mm3 when used in conjunction with
clinical staging can guide decision-making about when to start ARV
therapy.

Any patient who is seropositive and has a CD4 count below 250 is eligible
for ARV therapy regardless of WHO staging or symptoms
Where CD4 count is not available, clinical symptoms guide when to start
ARV therapy.

See Module 7, Unit 4 for more information on staging HIV infection in adults.
These constitute the medical criteria for adult eligibility to ARV therapy. It is
beyond the scope of this document to discuss social criteria for eligibility.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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APPENDIX 3-F Eligibility for ARV Therapy, Children (aged 14 years
or younger)
Eligibility for ARV therapy in children over the age of 18 months (See also national
ARV guidelines).
Children over the age of 18 months will be eligible for ARV therapy if:
 They are HIV-seropositive and
 They and/or their caregivers understand the implication of ARV therapy, plus the following conditions
shown below:
In these situations, the presence of a CD4 lymphocyte count may add
 WHO Paediatric Clinical
assist with decision-making. In children with TB, lymphocytic
Stage 4
interstitial pneumonia (LIP), oral hairy leukoplakia, or
 WHO Paediatric Clinical
thrombocytopenia, ARV therapy may be deferred if the CD4 count or
Stage 3
CD4 percentage is above the threshold value for starting ARV therapy
according to the child’s age.

WHO Paediatric Clinical
Stage 2
With a total lymphocyte count at or below the threshold value (see the
Malawi’s national guidelines on the use of ARV therapy or refer to the
WHO recommendations)

Children with a CD4
lymphocyte count or CD4
percentage below the
threshold value for starting
ARV therapy
See immunological table on the next page which represents WHO
recommendations.
Eligibility for ARV therapy in children younger than 18 months of age
Where virological confirmation of infection is NOT available: paediatric clients less than 18 months of
age should be referred to the ARV Clinic if:
A presumptive diagnosis of severe HIV disease requiring ARV therapy is made if the infant is
confirmed HIV antibody positive, AND

The infant is categorized in WHO Paediatric Clinical Stage 4 (this includes severe malnutrition)
OR
The infant is symptomatic with two or more of the following conditions:
i) oral candidiasis
ii) severe pneumonia
iii) severe sepsis
Other factors which support the diagnosis of severe HIV disease in an HIV-sero-positive infant
include:
i) recent HIV-related maternal death
ii) advanced HIV disease in the mother
iii) CD4 < 20% in children 12-18 months, and <25% in children less than 12 months.
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APPENDIX 3-F Eligibility for ARV Therapy, Children (aged 14 years
or younger) (cont’d)
WHO recommendations for initiating ARV therapy in infants and children
according to age-related immunological measures
Age-specific recommendation to initiate ARTb
Immunological
markera
≤ 11 months
12–35 months 36–59 months ≥ 5 years
c
CD4 %
< 25%
< 20%
< 15%
< 15%
< 1500
< 750
< 350
< 200
CD4 countc
cells/mm3
cells/mm3
cells/mm3
cells/mm3
To be used only in absence of CD4 assays:
< 4000
< 3000
< 2500
< 2000
TLC
cells/mm3
cells/mm3
cells/mm3
cells/mm3
Notes:
a. Immunological markers supplement clinical staging
b. ARV therapy should be initiated by these cut-off levels, regardless of clinical stage; a
drop of CD4 or TLC below these levels significantly increases the risk of mortality.
c. CD4% is suggested for children less than 5 yrs.
Source: WHO. Antiretroviral treatment of HIV infection in infants and children in
resource-limited settings, toward universal access: Recommendations for a public health
approach 2006 version, available at http://www.who.int/hiv/pub/guidelines/en/
See Module 7, Unit 5 for information on paediatric HIV staging.
Module 3 Specific Interventions to Prevent Mother to-Child Transmission of HIV (PMTCT)
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