PMTCT Guidelines for HIV Prevention 2024
PMTCT Guidelines for HIV Prevention 2024
Protocol
Collectively, countries have reduced new pediatric HIV infections from 270 000 [230 000-330 000] in
2009 to 110 000 [78 000-150 000] in 2015. More than 90% of these children are infected through
Mother to Child Transmission (MTCT). Without intervention, the risk of transmission is 15-30% in
non-breastfeeding populations. Breastfeeding by an infected mother adds an additional 5-20% risk
for an overall transmission rate of 20-45%. In resource limited settings, without combined triple
antiretroviral therapy (ART) treatment, 50% of HIV infected children die before the age of two.
In developed countries, effective prevention of mother to child transmission (PMTCT) has reduced
HIV transmission to < 1 %. The systematic implementation of these protocols has made pediatric
infection an increasingly rare problem in contexts where adequate health care is accessible. Over
the last few years significant impact has also been made in resource limited settings. In the 21 African
priority countries in the Global Plan, which account for over 90% of all pregnant women living with
HIV and new infections among children globally, PMTCT coverage in 2015 increased to 80% with
mother-to-child transmission rates declining overall from an estimated 26% [24-30%] in 2009 to 8.9%
[15-20%] in 20151. Despite the significant scale up in services a lot remains to be done.
In resource-limited settings, the current WHO 2016 guidelines2 recommend lifelong antiretroviral
therapy (ART) for all HIV positive pregnant women regardless of their CD4 count (formerly called
option B+).These recommendations make it possible to reduce mother to child HIV transmission to
less than 5%.
Earlier ART for all HIV-positive pregnant women, benefiting both the health of the
mother and preventing transmission to her child during pregnancy and in future
pregnancies;
Provision of antiretroviral (ARVs) to the mother to reduce the transmission during the
breastfeeding period;
Potential reduction of sexual transmission if the partner is HIV negative.
Many women do not access antenatal care (ANC) services due to a number of socio and
economic barriers; even less to postnatal care (PNC);
The majority of the women attending antenatal services are unaware of their HIV status;
When testing is available, many women find it difficult to disclose their status to their
partner or relatives making it more difficult for them to adhere to ARVs;
Many women attend antenatal services only once or twice during their pregnancies
and/or do not deliver in health facilities making the implementation of the entire PMTCT
protocol difficult;
Despite the relative simplicity of the new PMTCT guidelines, it still may be difficult to implement
these recommendations within existing weak health services. Mother and child health (MCH)
services faced with a lack of human resources or adequate infrastructure, with poor working
conditions for professional staff etc, may face the greatest difficulties in introducing them on a
large scale.
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The present document is an updated version of the April 2014 MSF Protocol for PMTCT.
It reviews the currently recommended interventions to reduce transmission from the HIV infected
mother to her child, as well as the clinical management of HIV exposed infants including early infant
diagnosis. Prevention of HIV infection, family planning and management of unwanted pregnancies in
HIV positive women are also part of the PMTCT strategy, but are not addressed in this document.
This document provides practical guidance to the teams in the field and will need to be used
alongside existing national guidance where it exists. As such it does not propose all the possible
alternatives. Rather, it proposes the preferred choices, in consideration of:
- the usual contexts where MSF works
- the need to avoid complex protocols
For more information, refer to the WHO consolidated guidelines on the use of Antiretroviral Drugs
for Treating and Preventing HIV infection. Recommendations for a public health approach. 2016.
2.5. HIV breast-feeding exposed infants whose mothers are identified post-partum. ............. 12
2.6 - CTX prophylaxis for exposed infants: .............................................................................. 14
Chapter 3: specific cases ........................................................................................................ 14
3.1 Special considerations during labour and delivery ............................................................ 14
3.2. PMTCT antiretroviral protocol: HIV-2 or HIV-1 & 2 co-infection ...................................... 15
Chapter 4: Prevention of hepatitis ......................................................................................... 15
4.1. Prevention of hepatitis B (HBV) transmission in HIV co-infected pregnant women ........... 15
4.2. Prevention of hepatitis C (HCV) transmission in HIV co-infected pregnant women ........... 16
Chapter 5: Follow-up of HIV exposed infants.......................................................................... 16
5.1. Early Diagnosis of HIV Infection in Infants and Children <18 months ................................ 16
5.2. Algorithm for EID ............................................................................................................ 18
5.3. Clinical follow up ............................................................................................................ 21
Appendices ........................................................................................................................... 22
Appendix 1: HIV testing of the pregnant woman ............................................................................... 22
Appendix 2: Testing at birth .............................................................................................................. 25
Appendix 3: Summary table: use of RDT for HIV serology and NAT virology based on age ................... 25
Appendix 4: SOPs for Collection, storage and transportation of DBS samples ...................................... 26
Appendix 5: Patient Support, Education and Counselling (PSEC) in PMTCT Services ............................. 27
ART initiation counselling in Pregnant and Breast feeding women ................................................................. 27
Counselling follow up for pregnant and breastfeeding women ....................................................................... 29
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Abbreviations and acronyms
3TC: Lamivudine
ABC: Abacavir
ANC: Ante Natal Care
ART: Antiretroviral Therapy
ARV: Antiretroviral
ATV/r: Atazanavir/ritonavir
AZT: Zidovudine
BD: Bis in Die or twice daily
BF: Breast feeding
CTX: Cotrimoxazole
DBS: Deoxyribonucleic acid
DNA: Desoxyribonucleic acid
DTG: Dolutegravir
EAC: Enhanced Adherence Counselling
EFV: Efavirenz
EID: Early HIV Diagnosis
EPI : Expended Program on Immunization
FTC: Emtricitabine
FDC: Fixed Dose Combination
HBV: Hepatitis B Virus
HCV: Hepatitis C Virus
Lop/r: Lopinavir/ritonavir
MCH: Mother and Child Health
NAAT: Nucleid Acid Amplification Test
NAT: Nucleic Acid Testing
NNRTI: Non-Nucleoside Reverse Transcriptase Inhibitors
NVP: Nevirapine
OD: Once/Day
PCR: Polymerase Chain Reaction
PI: Protease Inhibitor
PMTCT: Prevention of Mother to Child Transmission (of HIV)
POC: Point of Care
PNC: Post Natal Care
PSEC: Patient Support Education and Counselling
RDT: Rapid Diagnostic Test
SP: Sulfadoxine-pyrimethamine
TB: Tuberculosis
TDF: Tenofovir
VL: Viral load
All pregnant women of unknown HIV status should be offered HIV testing at their first antenatal
visit. Women who initially test negative and seroconvert during pregnancy or breastfeeding are at
especially high risk of transmitting the virus to their infant (see chap 3.1). Hence women who test
negative early in pregnancy should be retested in the third trimester, at delivery and regularly (3-
6 monthly) throughout the breastfeeding period. It is suggested that attendance at expended
program of immunization (EPI), under 5 clinics and inpatient/outpatient departments (IPD/OPD)
is an opportunity to test women who have not attended ANC and re-test women previously tested
negative.
Pregnant women usually enter PMTCT services either through an HIV program, or through
antenatal consultations. In general, women who come for antenatal visits are informed that they
can take an HIV test while they wait for their consultation. Often, this is the first time they hear of
HIV. Information and counselling is essential to encourage women to test, to enroll into a PMTCT
program and to adhere to treatment.
b
Opt out means that the test will be done unless the mother specifically refuses. This information is given during
the talk
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Individual post-test session
The post-test session is crucial. It is meant to encourage and support a woman with HIV infection
to accept her status and the PMTCT intervention that will benefit both her health and that of her
future infant.
Explain the meaning of a negative HIV test and the importance of remaining HIV negative
Re-discuss methods of prevention (already explained in the pre-test information)
Discuss risky behaviors and the need for protection particularly during pregnancy and
post-partuma
Encourage the woman to return to take a test in 3 months or before delivery
Encourage her to bring her partner for testing
Give condoms now and at each antenatal visit
a
HIV MTC transmission rates are very high if HIV infection occurs during pregnancy or post-partum
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Starting ART treatment early:
Allows enough time for the mother to reach an undetectable viral load before the high risk
period of mother to child transmission (late pregnancy, labour, delivery and immediate post-
partum) and therefore significantly reduces the risk of transmission.
Decreases the mortality also in exposed but uninfected infants by its impact on the survival of
the mother.
Before ART is started, the pregnant woman should be retested prior to initiation (see annex 1).
This re-test should be on another specimen and ideally by another healthcare worker. However if
no other healthcare worker is available this should not delay the initiation of ARTb. She has to be
prepared and counselled (see annex 5). For additional information refer to “MSF HIV-TB Adult PEC
guideline, 2017”.
This process has to start as soon as the HIV status of the mother is known, and must be “fast-
tracked” aiming for initiation on the same day as diagnosis. Starting an intervention in HIV infected
pregnant women can be considered an ‘emergency’ especially for those who present in the 3 rd
trimester.
ART should be initiated as soon as possible in all pregnant and breastfeeding (BF) women living
with HIV regardless of WHO clinical stage at any CD4 count and continued lifelong. The ART
regimen should be chosen taking into account local protocols for the preferred first line regimen
for adults and adolescents in the country.
Dolutegravir (DTG) might become soon the preferred option as observational data are reassuring.
The current regimen of choice for all pregnant or BF women is the same as for any adult
tenofovir/lamivudine (or emtricitabine/efavirenz) [TDF/3TC (or FTC)/EFV)] as a one pill/once a
day, fixed dose combination (FDC). This is also the regimen of choice for pregnant/breastfeeding
women with TB;
2.2. Women already on ART more than 6 months when becoming pregnant
c
TDF is generally well supported in young women. CrCl availability is not a prerequisite to use TDF.
d
Nevirapine (NVP) should be started at half dose for 15 days. Contra-indicated in women > 350 CD4 and men > 400
CD4. See adult treatment guideline. If no CD4 available, choose another option.
d
NVP should be started at half dose for 15 days. Contra-indicated in women > 350 CD4 and men > 400 CD4. See
adult treatment guideline
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- If access to VL is not a problem, 6-monthly VL monitoring should be done during
pregnancy and BF. Women with VL > 1000 should be managed promptly according to
the usual suspicion of failure algorithm. Infants should be managed as high risk
infants.
- If VL is unavailable, confirm adherence, continue ART. Use CD4 criteria (50% fall from
the peak or return to below baseline) and/or clinical criteria (new opportunistic
infection, stage 3 or 4) to diagnose failure.
Start NVP syrup once/day (OD) as soon as possible after birth for 6 weeks.
Mother: Start ART for the mother as soon as possible if not yet under treatment. If during labour,
give first dose and continue for life. Ensure proper counselling is done after delivery.
Infant: As soon as possible after birth, start prophylaxis in the infant for 6 weeks using a quarter
of the triple dispersible AZT 60/3TC 30/NVP 50 tab twice daily (BD). Teach the mother on how to
use a cutter for obtaining 4 equal parts. At or around 6 weeks, perform an early HIV diagnosis
(EID) and switch to the dispersible NVP prophylaxis 50 mg tab ½ tab, OD (or 10 mg/mL syrup), for
another 6 weeks, unless the EID result is positive. In such a case, switch to full triple therapy.
Table 4: simplified enhanced prophylaxis for high risk infants, birth to 12 weeks
Simplified high risk infant prophylaxis
Dose AZT 60/3TC 30/NVP 50 FDC tab dispersible Dose NVP 50 tab dispersible (or 10 mg/mL syrup)
Birth to 6 weeks 1/4 BD
6 weeks to 12 weeks 1/2 OD (or 2 ml syrup)
This simplified prophylactic regimen has not been formerly evaluated yet but has been discussed
with WHO experts who recognize the importance of simplicity for success.
The classical WHO proposed regimen (2016) is described below and should be used if this is the
national recommendation.
o From birth to 6 weeks, this is a 2 drugs regimen.
o From 6 to 12 weeks, there are two options: 1 drug only (NVP) or 2 drugs (AZT + NVP).
If this is too complicated for the mother, choose the simplified one above.
e
Defined as a new HIV diagnosis in a pregnant or BF woman with a previous negative test during pregnancy
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Table 5: enhanced prophylaxis for high risk infants, classical regimen from birth to 12 weeks:
High risk infant prophylaxis
Dose NVP (10 mg/mL syrup or 50 mg tab once daily-OD) Dose AZT (10 mg/mL syrup or 60 mg tab twice daily-BD)
Birth to 6 weeks 15 mg OD (1.5 mL syrup OD) 15 mg OD (1.5 mL syrup OD) - or NVP alone-
6 weeks to 12 weeks 20 mg OD (2 mL syrup OD) or 1/2 50 mg tab OD 60 mg tab BD -or NVP alone-
If none of these formulations are available, give NVP alone for 12 weeks
CTX prophylaxis is added for all exposed infants > 4-6 weeks of age till exclusion of infection (see
table 6). Continue CTX prophylaxis for those infected.
2.5. HIV breast-feeding exposed infants whose mothers are identified post-partum.
HIV positive women may present for the first time with a breastfeeding infant, having not been
through any PMTCT intervention. Such infants are at especially high risk of already having been
infected and might therefore benefit from presumptive treatment until proven otherwise. The
infant should be tested with an age appropriate HIV test (virological testf if < 18 months; rapid
testing algorithm if > 18 months) and considered as a “high risk infant”.
- The mother should start ART without delay and with counselling support.
- The infant:
o If the infant virological test is available same day (POC):
Result is positive, start ART treatment without delay according to weight with
ABC (or AZT)/3TC + LPV/rg. Confirm infection at next visit with a second
sampleh.
Result is negative, start enhanced prophylaxis according to age (NVP) and
weight (AZT) (table 6)
o If the infant virological test result is delayed (e.g. using DBS), start presumptive
treatment with AZT (or ABC)/3TC + LPV/r while awaiting the result of DBS-PCR.
If the DBS-PCR result comes negative, presumptive treatment can be stopped
and the infant continued on daily NVP for a total of 12 weeks since the mother
started ART.
f
Nucleic Acid Testing (NAT) through POC or DNA-PCR through DBS
g
LPV/r in pellets is preferred from age 3 months.
h
To exclude errors during laboratory procedures
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Perform another DBS-PCR (or RDT first, according to age) at the end of the
prophylaxis.
Table 6: High risk infant prophylaxis when exposure discovered during breastfeeding (AZT)
AZT prophylactic dosage
Weight AZT 60 mg or AZT 60/3TC 30 AZT syrup 10 mg/ml
mg dispersible tabs
3.0 – 5.9kg 1 BD 6 ml BD
6.0 – 9.9 kg 1.5 BD 9 ml BD
10 – 13.9 kg 2 BD 12 ml BD
14 – 19.9 kg 2.5 BD 15 ml BD
- At any age, if the infant has a HIV rapid diagnostic test (RDT) positive and clinical signs of HIV
infection, start ART. Perform a nucleic acid testing (NAT) POC or collect a dried blood spot
(DBS) prior to starting ART for later NAT testing to confirm HIV diagnosis. Infection should be
confirmed with a NAT test before 18 months of age and a RDT after 18 months and/or 12
weeks post BF cessation whichever is later.
- Infants > 9 months and well but RDT positive need prompt NAT to confirm infection.
- Infant > 9 months and RDT negative, HIV is unlikely unless still BF. Continue clinical
monitoring. Final status will be given with RDT after 18 months and/or 12 weeks post BF
cessation whichever is later.
N.B: Management of infants who started ART early and for whom we wish to confirm HIV
status at 18 months by RDT should be cautious:
- If serology negative, consider sero-reversion and perform DNA-PCR or NAT
- If DNA-PCR negative discuss with HIV Advisor (advice to perform ultrasensitive methods of
HIV detection) since standard DNA-PCR (or NAT) might be falsely negative in some children
starting ART early in life.
Do not delay ART initiation in children with clinical signs of HIV infection even if you don’t have
access to a fast virological test results.
Newborn care
As standard precautions are to be applied to any woman and newborn in the maternity ward,
there are no special measures for HIV exposed infants.
HIV-2 is not sensitive to the NNRTI class (NVP or EFV). Use a PI based regimen (ATV/r or LPV/r).
Integrase inhibitors work in HIV-2 but no data exist yet on safety during pregnancy. To use only if the
potential benefit justifies the potential risk.
HIV-2 is much less transmissible from mother to child (1-3%) than HIV-1. WHO does not give any
recommendation on when to start ART for PMTCT in HIV-2 and HIV-1 & 2 co-infection. Follow
national protocols. However, don’t use a NNRTI based regimens in pregnant women. Use TDF + 3TC
(or FTC) with a PI (ATV/r or LPV/r) or a DTG containing regimen. Do not use NNRTI for the infant, even
as prophylaxis, use AZT syrup (birth weight < 2500 g, 10 mg/dose twice daily; birth weight > 2500 g,
15 mg/dose twice daily).
High maternal HBV viremia and HBe Ag positive statusj are correlated with a higher risk of HBV
transmission. However in HIV-HBV co-infected patients, the current recommended 1st line ART
regimen TDF/3TC (or FTC)/EFV is treating and preventing transmission of both diseasesk.
1. Mother’s treatment:
j
Without treatment, nor immunization, risk of HBV transmission is estimated at 70-90% in HBe Ag pos and 10-40%
in HBe Ag neg mothers
k
HBV drugs in this regimen are TDF and 3TC (or FTC)
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It has been shown that co-treatment of HBV and HIV with an ART regimen containing
TDF/3TC is highly successful in preventing transmission of both virus to the infant. Choose
an ART regimen containing TDF/3TC (or FTC)5.
When changing to a 2nd or 3d line, keep at least TDF (+/- 3TC (or FTC)) in addition to the new
ART regimen regardless of previous exposure and HIV resistance to TDFl.
Provide the first dose of hepatitis B vaccine (monovalent) at birth or within the first 24
hours. Use the adult monovalent vaccine at 1/2 dose (0.5 ml) or HepB pediatric vaccine.
Ensure that the infant receives the other doses through the EPI (DPT-Hib-HepB pentavalent
vaccine)
Women with negative HBs Ag status and who have not been vaccinated in the past (see
immunization card) should be vaccinated at Day 0, M1, M6.
Pregnant women co-infected with HIV-HCV have a 5 to 20% risk to transmit the HCV virus to their
infant. At the moment there are no data about the use of HCV drugs in pregnancy and BF. No
recommendations are yet available. Where access to diagnosis (HCV RDT and HCV VL) is available,
treatment using the new direct acting antiviral drugs may be offered after breastfeeding in order to
prevent transmission in future pregnancies. (See Hepatitis C care for MSF projects. 2017. In
validation process6).
5.1. Early Diagnosis of HIV Infection in Infants and Children <18 months
Infants and children can be infected with HIV during pregnancy, delivery or post-partum through
breastfeeding. Infants infected in utero usually have already detectable HIV viral load when tested at
birth. In contrast, infants infected during or around delivery usually have undetectable HIV viral load
when tested at birth because it takes approximately 1-2 weeks following infection for the virus to be
detectable by viral assays.
For infants and children under 18 months of age, serological antibody detection assays are not
suitable because passive transfer of maternal antibodies may lead to a false positive result. Thus,
l
Removing the HBV treatment can lead to severe hepatitis flare
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virological assays, such as NAT or HIV DNA (DNA-PCR) are recommended for EID in infants <18
months of age. For infants older than 18 months, an antibody detection test can be used because the
maternal antibodies have been cleared from the infant's blood. Use the adult algorithm.
A NAT or a nucleic acid amplification test (NAAT) is a molecular technique used to detect a particular
pathogen (virus or bacterium) in a specimen of blood or other tissue or body fluid. NAT is the
recommended testing method to diagnose infants and children <18 months. The DNA-PCR is a NAT
test. See annex 5.
Serological testing using rapid diagnostic tests (RDTs) can be considered in infants aged 9-18 months
only to rule-out infection if NAT testing is not available. See annex 4.
Point of care (POC) devices for EID are now available and are a very practical option. Results are
available within 2 hours.
If HIV NAT cannot be performed in the project, the specimens are to be sent to an external laboratory
using dried blood spots (DBS). Refer to Annex 5.
HIV Infant Diagnosis by NAT using Dried Blood Spot (DBS) or POC
Early testing is recommended to diagnosis HIV infected children as soon as possible in order to
initiate them on ART and reduce early mortality.
Initial testing (NAT1) is usually recommended at the first post-natal visit (usually 4-6 weeks).
Some countries are starting to use DBS at birth (earlier case finding for perinatal infection and to
possibly reduce early lost to F/up). Refer to national protocols and annex 2. Where birth testing
with the subsequent repeats is not feasible for all exposed infants, priority may be given to those
infants classified at high risk or where no PMTCT was provided to the mother.
Caution:
If initial testing was done at/or around birth and was HIV negative, a second test must be
performed at 4-6 weeks (to detect intra-partum and early post-partum transmission).
4-6 weeks is indicative. Week 6 is convenient because this is also the date of the first DPT-
Hib-HepB1. But never turn away a mother because she comes earlier or later to test her
infant.
Result Interpretation
If NAT1 is NEGATIVE: Report the result as "HIV-negative". There is no need to confirm a negative
result with a second NAT, unless the first test was done at or around birth.
If the first result (NAT1) is POSITIVE: Start ART as soon as possible and collect immediately a second
specimen for confirmation (NAT2).
A positive HIV result obtained from virological testing of an infant or child younger
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than 18 months should always be confirmed by a second virological test
taken at the time when the first result is given.
o The confirmation of the initial positive result is recommended in order to reduce errors
during sampling, transportation and/or testing.
o The confirmation test should be performed in the same laboratory as the first test. This
allows follow-up on the consistency of the results and investigation of discordant results.
o Data should be collected including at a minimum: age of child, results of NAT1 and NAT2
and dates of blood collection.
If the second result (NAT2) is also POSITIVE: Report final result as "HIV-positive".
If the second result (NAT2) is negative: This is a discordant result. Refer to your HIV referent or
laboratory advisor.
Important notes:
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Source: WHO: The use of antiretroviral drugs for treating and preventing HIV infection. 2016
Additional information:
Children remain at risk of HIV infection as long as they are breastfed. All HIV NAT negative
children must be re-tested using antibody-based tests (e.g. Rapid Diagnostic Tests) to confirm
the final status after 18 months and/or 12 weeks after cessation of breastfeeding, unless child
was never breastfed.
In projects which do not have the capacity to do so, earlier discharge between 12-15 months
may be considered if a negative antibody HIV test is obtained and the baby has not breastfed
during the past 12 weeks.
Keep in mind that :
o The likelihood of a false positive result decreases when clear clinical symptoms of HIV
infection are present.
o The likelihood of a false negative result increases when there are clear clinical indications
of an HIV infection:
o If a child tested negative once but has new symptoms compatible with HIV disease, testing
must be repeated (and treatment started following the MSF Pediatric HIV Handbook).
o The likelihood of a false positive increases with a well-functioning PMTCT program (as HIV
prevalence in infants decreases, predictive positive value of the test decreases as well and
false positive results increase).
HIV exposed infants should be followed until HIV infection can be ruled out or confirmed, usually till
18-24 months. During the first year, consultations should match the EPI calendar. From 6 weeks to 6
months, 1 consultation/month is needed. Thereafter, a 3-monthly schedule can be proposed. Ensure
that the child health record with immunization (usually provided by MoH) is filled out at each visit.
Always assess the mother and child’s care together as a family. Encourage testing of the partner and
other siblings.
At each consultation:
Check age and weight. Plot on the WHO growth chart. If outside of normal percentiles, measure
height and calculate BMI. If the growth curve is flattening or crossing lower centiles, action is
required
Check clinical status, growth and neuro-developmental status including cranial perimeter.
Look for signs of TB and potential TB contacts. Ensure INH prophylaxis if mother is on TB
treatment.
Advise on nutrition (encourage exclusive breastfeeding till 6 months, complementary feeding
to be introduced thereafter). Breastfeeding should be respected till around 24 months. In some
projects, supplementation can be givenm.
Prevent and treat mother’s breast problems (mastitis, cracked nipples, abscess, herpes) and
thrush in infants, conditions that are known to increase transmission.
Check immunisation completion for age and verify the infant has a mosquito net.
m
Such as plumpy Doz/BP 100
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Appendices
MSF recommends following WHO recommendations on HIV testing based on the consolidated
guidelines on HIV testing services 20157. This strategy for diagnosis depends on the prevalence of the
setting where the tests are used. Three positive RDT tests are needed to confirm a positive HIV status
in low prevalence settings (< 5%) whereas 2 positive RDT tests are needed in high prevalence settings
(> 5%). This means that there may be different testing strategies in use in one country or even within
one testing facility (e.g. the ANC clinic may have a testing prevalence of 2%, thus should use the
testing strategy for low prevalence settings but the HIV testing center at the TB clinic might have a
prevalence of 10% and should therefore use the testing strategy for high prevalence settings). If the
prevalence is unknown or if it is too complex to have 2 different algorithms within one testing facility,
it is recommended to use the low prevalence testing strategy.
In both high and low prevalence settings, three different serological assays (A1, A2, A3) may be
required to establish the diagnosis of HIV infection. A1 should be the most sensitive assay available
and A2 (and A3) have the highest specificity.
MSF recommends using Determine as A1, STAT-PAK as A2 and SD Bioline or Uni-Gold as A38.
Important: All individuals that are diagnosed HIV-positive should be retested prior to starting ART
to verify their HIV-positive status. When same day initiation is being performed, the re-testing
should be performed by a different person using a different sample.
Serological testing strategy for HIV diagnosis in high prevalence settings (≥5%)
According to WHO guidelines, MSF recommends, for high prevalence settings (> 5%) that a diagnosis
of HIV positive be provided to people with two sequential reactive tests.
For individuals with discrepant test results where A1 is reactive, A2 is non-reactive and A3
is reactive, the results should be considered inconclusive and the client should be asked
to return in 14 days for retesting.
For individuals with discrepant test results where A1 is reactive, A2 is non-reactive and A3
is non-reactive, the final result should be considered HIV negative.
Important: For individuals with A1+, then A2−, then A3+, using the reactive test result from the third
assay as a tiebreaker to rule in HIV infection and issue an HIV-positive diagnosis is not recommended;
it over-selects for false-positive results and, therefore, leads to greater potential for misdiagnosis of
HIV infection.
Serological testing strategy for HIV diagnosis in low prevalence settings (<5%)
According to WHO guidelines, MSF recommends, for low prevalence settings (< 5%) that a diagnosis
of HIV positive be provided to people with three sequential reactive tests.
For individuals where the Assay 1 result is reactive and Assay 2 result is non-reactive, the
final result should be considered HIV negative.
For individuals with results in which Assay 1 is reactive, Assay 2 is reactive and Assay 3 is
non-reactive, the result should be considered inconclusive and the client should be asked
to return in 14 days for retesting.
Figure 2: Serological testing strategy for HIV diagnosis in low prevalence settings (<5%). Source:
The Use of Antiretroviral Drugs for Treating and Preventing HIV Infection. WHO 2016.
In settings where transmission risk is low (< 5% at 6 weeks) as result of good PMTCT coverage,
adding birth testing may be considered as up to 70% of the residual perinatal transmissions
(intrauterine and intrapartum) are expected to occur in utero. Where resources are limited, priority
should be given to high risk infants. However as the positive predictive value of any test is lower in
settings where the prevalence of HIV in the population being tested is low, the proportion of false
positive results will be relatively high. It will therefore be critical to ensure retesting of any positive
result, as recommended for all positive, by a NAT test. ART should be initiated without the result of
the 2nd test because of the high risk of mortality with in utero infection; if the 2nd test is negative, a
3d NAT should be performed before stopping ART.
In settings where transmission risk is high (> 5% at 6 weeks) as a result of poor coverage of PMTCT
program, the proportion of children with in utero infection is lower. The negative predictive value
of the test is low. It is therefore critical to ensure retention in the testing cascade and actively track
infants who test NAT negative at birth.
Appendix 3: Summary table: use of RDT for HIV serology and NAT virology based on age
Dried blood spots [DBS] are clinical samples collected by applying a few drops of blood onto an
absorbent sample collection [filter] paper. The blood is allowed to saturate the paper thoroughly and
then air-dried. DBS cards [e.g. 903 protein saver card from Whatman, ref. code: 10531018 [MSF code:
ELABPAPF903]] can be sent to laboratories where the samples are analyzed. Once in the laboratory,
a small disc of saturated paper from the DBS card is punched out to elute the blood/plasma from
filter paper, which is used for testing.
Caution: there is a high risk of cross contamination from capillary blood sampling to laboratory testing
if proper procedures are not followed.
1. Required material
- Blood collection material incl. powder-free gloves
- Sample collection card: e.g. Protein SaverTM 903® Card Whatman or Munktell
- Drying rack
- Low gas permeable zip-lock bag
- Desiccant bags
- Humidity card: Tropack Indicator B/1
- Rip-resistant envelope
Important: For DBS collection in infant the HEEL LANCET for infants [MSF code: ELABLANC2H-]
should be used as this lancet creates a higher blood flow than regular lancets.
DBS are not considered infectious material regarding international regulations (exemption
from UN 3373 and UN 2814 shipment regulations). It is possible to transport them by
regular mail services at room temperature.
Place zip-lock bags containing DBS in a rip-resistant envelope with the necessary documents:
laboratory test request forms and list of enclosed DBS.
Motivation for taking medication – to keep the infant negative and in the longer term to keep
herself healthy and to care for the child.
How to take the medication. Once a day; same time; what tools will be used to remind.
At subsequent sessions ongoing counselling and assessment of HIV knowledge must be further
developed. In addition the woman must be counselled, on planning a safe delivery, the NVP (+/-AZT)
and CTX that her infant will need, testing her infant and feeding advice.
If the woman has concerns about life long treatment these should be further discussed during follow
up sessions but for now encourage her that the immediate motivation is to keep her infant negative.
In addition a baseline CD4 will be taken (needed to assess for late presenter treatment and to monitor
treatment response if viral load not available). This will also guide further discussions. In future
sessions it can also be explained that continuing on ART not only will keep her healthy but will also
protect any future pregnancy much earlier.
Lack of disclosure is a very common reason for pregnant or BF women not to take their medication.
Start to discuss options for how she might disclose to her partner but do not insist on it during the
first session. This difficult theme will be discussed more deeply during further sessions.
Finding out you are HIV+ is a lot to deal with today but it is important that we already
speak for a moment about the health of your infant. You could have a HIV- infant if
you take the right precautions:
Through these 4 actions you will protect your infant and the chances of him or her
becoming infected are very small. Today we will focus on how to take the treatment for
you and your infant correctly and we will cover other topics at later sessions. We will
make a plan together to enable you to take the medication for you and your infant
correctly.
4. Make a plan with the patient on how to take ARVs? Cover the following aspects
6. Ask if they have any questions and explain they are going to be booked for a second
session at week 2 on ART
7. Aim where possible to link the woman with a community health worker or PMTCT “
Champion” who can support them in the community
8. Ask their consent that if they miss an appointment they will be called or be traced.
Counselling follow up should be at month 1, 3, 6 and 12 as for normal ART follow up. In addition to
assessment of adherence, topics related to their stage of PMTCT should be incorporated into the
counselling content: planning a facility based delivery: NVP use; DBS testing; CTX use; Infant feeding
advice. There are also some key “Transition points” in the journey of PMTCT where key messages
should be emphasized.
Planning where the woman will deliver or if she will travel away from the facility who has
initiated her ART. Consideration of cultural practices must be discussed and if needed
extended drug supplies given or referral to another ART site.
Exclusive breast feeding for 6 months is the recommended infant feeding option. When the
woman is seen post-delivery it is very important to explain that the medication she is taking
is making her breast milk safe. The chances of transmitting HIV to her infant if she takes the
medication daily are very, very low. So her motivation for taking the medicine is still to keep
her infant negative and to keep herself healthy
She should be reassured that the medication she is taking is not harmful to the infant
During the subsequent sessions further discussion about lifelong treatment can be developed.
When she is about to stop breastfeeding is an important stage as prior to this she has the
additional motivation for treatment of keeping the infant negative. Now the treatment is for
Give basic HIV and ART education and see what the woman remembers. Recap as needed
Give PMTCT specific education
Making a delivery plan:
One of the key moments where transmission of the virus can occur is during delivery. This
is why it is best to deliver at a health facility. If you inform the health staff about your
status, they will know how to handle the delivery so that the risk of transmission to the
infant is as low as possible. Preparing well for delivery means:
knowing to which hospital or health centre you will go
knowing how you will tell the medical staff you are HIV+
having identified someone who will take you there
knowing how you will reach the hospital (transport)
having prepared enough of your own medication to take with you
making arrangements for your absence from home (e.g., who will care for your other
children while you are in the maternity).
Explain about exclusive breastfeeding in first six months and inclusion of other foods later
Explain about treatment for the infant:
- Right after birth, the infant will need to take a protective syrup for 6 (or 12) weeks,
called Nevirapine – NVP (+/- zidovudine - AZT), this as well as the medication you are
taking will protect the infant from becoming HIV positive.
- The chance for your infant to become infected will be very small if you take the right
precautions, but it's still possible. It is important to know as soon as possible if the
infant is HIV+, so that he can start to take the treatment. This treatment will keep him
strong.
- We will propose an HIV test for your infant a few times during the period of
breastfeeding. The first test is usually done 6 weeks after birth but may be offered
earlier (according to local protocols) . We will send some blood for analysis, after a few
weeks you will receive the results. As during breastfeeding, the infant can still get
infected, it is only after you stopped breastfeeding that we will take a final and
conclusive test.
Ask the women if they have any questions and explain they are going to be booked for a
next session at month 2
1
http://www.unaids.org/sites/default/files/media_asset/GlobalPlan2016_en.pdf
2
Consolidated guidelines on the use of Antiretroviral Drugs for Treating and Preventing HIV infection.
Recommendations for a public health approach. WHO: June 2016.
http://apps.who.int/iris/bitstream/10665/208825/1/9789241549684_eng.pdf
3 https://mymsf.org/jcms/195995_DBFileDocument/fr/msf-hivtb-clinical-guide-2015-english
4
“Obstetric in remote settings –Practical guide for non-specialized health care professionals”. MSF 2014 version.
5
HBV in pregnancy. CID 2016:62 (suppl 4)
6
Hepatitis C care for MSF projects. MSF-OCP, 2017.
7
http://apps.who.int/iris/bitstream/10665/179870/1/9789241508926_eng.pdf?ua=1&ua=1
8 MSF policy on HIV testing and monitoring; LWG, July 2017
9
HIV-TB Adult PEC guideline 2017. More specifically to annexe-21 (PEC guide PMTCT B+_eng-final-May 2013.doc)
and the flipcharts in Annex-22 (PMTCT_B+_Flipchart_2013_EN.pdf)
10
The Family Planning Handbook (https://www.fphandbook.org/)