Figure S1: Overview of PMTCT Options A and B Prevention of Mother to Child HIV Transmission (PMTCT) Option A: combined Antiretroviral therapy (ART) for all women meeting WHO 2010 criteria for initiation (CD4<350, WHO Stage III or IV) and Nevirapine for the infant during the first 6 weeks of breast-feeding. For those women with CD4>350 or WHO Stage I/II, prophylactic (short course) treatment with Zidovudine for the mother during pregnancy from the 14 th week of gestation; intra-partum combined ART, and Nevirapine for the infant during the entire breast-feeding period 21. Option B: Combined ART for all women regardless of CD4 and clinical stage. However, this is stopped after complete cessation of breastfeeding in those women not meeting WHO 2010 criteria for ART initiation (CD4>350 or WHO Stage I or II). Nevirapine is given to the infant during the first 6 weeks of the breast-feeding period 21.
Supplementary information S1: Details of PMTCT B+ pilot implementation in Nhlangano Health Zone, Shiselweni, Swaziland (Jan July 2013) Clinical SOPs for the PMTCT B+ pilot programme were developed by MSF with support from the Swaziland National AIDS Program (SNAP) and the Sexual and Reproductive Health Unit (SRHU) of the Ministry of Health. When the pilot was launched, the country as a whole continued to follow the PMTCT option A approach. Sensitisation of the population of Nhlangano health zone, selected for the PMTCT B+ pilot, relied on stakeholder meetings, training workshops for health workers, and community mobilisation carried out within the health zone, rather than media (TV, radio or print). Combined ART would henceforth be offered to all pregnant and breastfeeding HIV+ women after counselling. Ideally it should be initiated within one week of the first ANC appointment, and no later than 32 weeks gestation. After discussion with the SRHU, it was agreed that prophylactic therapy (Zidovudine for mother, Nevirapine for baby) would still be offered to women refusing combined ART, since if this was not offered women hesitant about starting ART might seek care in other health zones, or may leave the ANC visit without an effective ARV intervention for preventing vertical transmission. At the start of the pilot study, same day initiation of combined ART was not encouraged. This decision was made following discussions with the National PMTCT Technical Working Group (led by the Swaziland Ministry of Health), where it was felt that same-day initiation would result in coercion of patients and high early attrition. However, after 3 months it was noted that median time to ART initiation was well over the one-week target, a decision was made to adapt the SOPs in favour of same-day initiation, for women who were ready. Women not ready to initiate would be invited for review one week later, at which time prophylactic therapy (Zidovidine/ Nevirapine) would be proposed if the woman was still not ready to start combined ART. These updated SOPs were issued in July 2013 and are available online (online supplementary information S2).
PMTCT B+ - Standard Procedures for Antenatal care All pregnant women should have an HIV test (unless known to be HIV+), and be screened for TB. If TB suspect, follow up care as usual. Encourage partner to be tested for HIV, and invite him to next visit. If the patient tests negative for HIV: Provide HIV post test counselling, including condom demonstration and strategies for risk reduction. Ensure partner knows his HIV status. Advise the patient that they should be retested for HIV every 8 weeks throughout pregnancy and breast-feeding If the patient is known to be HIV+, and is already on combined ART: Continue her current treatment. This includes TDF and EFV based regimens, which are safe in pregnancy. Ensure patient has a Chronic Care file, and is registered in the ART register If the patient is HIV+ but not on combined ART (i.e. newly diagnose, or previously diagnosed but not on treatment, or only taking AZT prophylaxis): Ensure post-test counselling if newly diagnosed HIV+. Open file and register in the pre-art register. Carry out clinical staging and ensure standard lab tests are done: Hb, CD4 (if not done in last 3 months), VL, renal function, liver function, Urinalysis. If available, do VDRL, Hep B and C. Explain that in Nhlangano zone, all HIV+ pregnant women are recommended cart. Ensure that she has seen the PMTCT information sheet available in the clinic. Initiate cart if no contraindications, and ensure patient is registered in the ART register. o Refer to EC for 1 st session of ART readiness counselling today. EC should book 2 nd session for within 1 week. Her 3 rd counselling session should happen at her next ANC visit. If the woman is not ready to initiate ART today, do not give AZT (unless > 32 weeks pregnant)*. Book a 2 nd appointment for 1 week, and refer to EC for 1 st session ART readiness counselling today o At the 2 nd appointment, initiate cart if no contraindications and she is now ready. Refer to EC for 2 nd session of ART readiness counselling today (3 nd session at next ANC appointment) o If the woman is still not ready to start ART, address her concerns and remind her of the need for ART to protect the baby. If she still refuses ART, start the prophylactic regimen (AZT for mother from 14 weeks of pregnancy, intra-partum ARVs, extended NVP for baby). o If the woman misses any appointment, call her and book an urgent appointment. When she next comes to ANC, initiate cart if no contraindications and she is now ready. If the woman is still not ready to start ART, start the prophylactic (AZT-based) regimen. All pregnant women should receive NVP syrup for the baby At every visit, give adherence counselling (Nurse and EC) for all patients newly initiated on cart. * If the woman is more than 32 weeks pregnant, she must not leave the clinic without an ARV treatment (initiate cart if she is ready, if not the prophylactic (AZT-based) regimen).
PMTCT B+ - Standard Procedures for Antenatal care Known HIV+ on ART Known HIV+ not on cart (includes women on AZT). Check Hb, U&E, LFT, urine, Staging, CD4, VL. HIV- or unknown Do HIV test HIV + Do post-test counseling; enroll in pre- ART. Check Hb, U&E, LFT, urine, Staging, CD4, VL. HIV - give post-test counseling Continue current ART regimen. Explain that she should start cart today. If she is already on AZT, offer to change Re-test for HIV at every visit. If not ready to start ART do not give AZT* Refer to EC for 1 st ART readiness counseling Book 2 nd appointment within 1 week. If patient does not attend counseling visit, contact patient and book to see nurse. At 2 nd appointment, counsel patient on ART Initiate ART (TDF-3TC-EFV) ᶧ Enroll in ART register. Give 1 bottle NVP for baby Refer to EC for ART readiness counseling today continue to complete 3 counselling sessions (before or after initiation) Give ongoing adherence support Patient to see Nurse and EC at every visit Phone patient if she misses any appointment Patient now ready to initiate ART Patient still not ready to initiate ART at 2 nd appt: Offer prophylactic treatment with AZT Give 1 bottle NVP syrup for baby. Offer patient the option to change to ART at every visit Note: * If the woman is more than 32 weeks pregnant, she must not leave the clinic without an ARV treatment (initiate cart if she is ready, if not the prophylactic (AZT-based) regimen). ᶧ Contraindications to TDF-3TC-EFV are summarized in the National ART Guidelines. If the woman has renal impairment, AZT-3TC-EFV can be given. If EFV intolerant, use NVP based regimens
PMTCT B+ - Standard Procedures for Maternity care All pregnant women should have an HIV test (unless known to be HIV+), and be screened for TB. If TB suspect, follow up care as usual. Encourage partner to be tested for HIV, and invite him to next visit. If the patient tests negative for HIV: Provide HIV post test counselling, including condom demonstration and strategies for risk reduction. Ensure partner knows his HIV status. Advise the patient that they should be retested for HIV every 8 weeks throughout breast-feeding If the patient is known to be HIV+, and is already on combined ART: Continue her current treatment If the patient is HIV+ but not on combined ART (i.e. newly diagnosed, or previously diagnosed but not on treatment, or only taking AZT prophylaxis): Provide post-test counselling in the case of a new diagnosis of HIV. Ensure the patient has a Chronic Care file, and is registered in the pre-art register Ensure that the patient has seen the PMTCT information sheet available in the facility. Explain that in Nhlangano Zone, all HIV+ pregnant and breast-feeding women are now recommended combined ART. Address any questions she has about this. Inform the woman that she will be offered this treatment at the PHU / Clinics after her discharge. To protect the baby, the woman should receive single dose intra-partum Nevirapine and 1 week AZT / 3TC. She should also receive 1 bottle of Nevirapine syrup for the baby. However, at discharge from maternity, the woman is referred to the PHU or PHC for initiation of combined ART. If the woman is discharged when the PHU is closed, she should be advised to attend the PHU or PHC as soon as possible. Give appointment date at the mother s PHC or PHU, and document in the mother s card and child welfare card. Document mother s contact details, and the details of her treatment supporter (e.g. cell phone numbers) both in the mothers file and the maternity and appointment register.
PMTCT B+ - Standard Procedures for Maternity care HIV + on combined ART HIV + on AZT or no PMTCT treatment HIV or unknown Do HIV test Normal maternity care. HIV + do post-test counseling and enroll in pre-art care HIV- give posttest counseling. Continue normal maternity care Explain that she should initiate ART after delivery (if on AZT, can change to combined ART) At delivery, give SD NVP and AZT/3TC for 7 days to mother, initiate NVP syrup for baby Refer to PHU or PHC after delivery for initiation of combined ART Note: The algorithm is applicable only in early labour or after delivery. If woman presents in advanced labour, the algorithm should be applied after delivery, before the mother is discharged from maternity.
PMTCT B+ - Standard Procedures for Postnatal and Child Welfare follow-up All women should have an HIV test (unless known to be HIV+), and be screened for TB. If TB suspect, follow up care as usual. Encourage partner to be tested for HIV, and invite him to next visit. If the patient tests negative for HIV: Provide HIV post test counselling, including condom demonstration and strategies for risk reduction. Ensure partner knows his HIV status. Advise the patient that they should be retested for HIV every 8 weeks throughout breast-feeding. If the patient is known to be HIV+, and is already on combined ART: Continue her current treatment. Check her Viral Load if not done at delivery. The mother s viral load should be rechecked every 6 months until baby is 2 years old. If the patient is HIV+ but not on combined ART (i.e. newly diagnosed, or previously diagnosed but not on treatment, or only taking AZT prophylaxis during pregnancy): Give post-test counselling if newly diagnosed HIV+. Open file and register in the pre-art register. Explain that in Nhlangano zone, all HIV+ pregnant women are recommended cart. Ensure that she has seen the PMTCT information sheet available in the clinic. Start Nevirapine syrup for the baby (if breast-feeding). Explain that all HIV+ breast-feeding women are recommended combined ART. Ensure that she has seen the PMTCT information sheet. Carry out standard lab tests if not done since delivery: Hb, CD4 (if not in last 3 months), VL, renal / liver function, urinalysis. If available: VDRL, Hep B and C. Check baby s HIV status if due (see algorithm). If baby s DNA PCR test is positive, the baby must also be initiated on ART immediately. Start mother on cart if no contraindications, and ensure patient is registered in the ART register. o Refer to EC for 1 st session of ART readiness counselling today. EC should book 2 nd session for within 1 week. Her 3 rd counselling session should happen at the next PNC / CW visit. If the woman is not ready to initiate ART today, book a 2 nd appointment for 1 week, and refer to EC for 1 st session of ART readiness counselling today o At the 2 nd appointment, initiate cart if no contraindications and she is now ready. Refer to EC for 2 nd session of ART readiness counselling today (3 nd session at next routine visit) o If the woman is still not ready to start ART, remind her of the need for ART to protect the baby. If she still refuses ART, continue extended Nevirapine for whole breastfeeding period. o If the woman misses any appointment, call her and book an urgent appointment. When she next comes to ANC, initiate cart if no contraindications and she is now ready. If the woman is still not ready to start ART, continue Nevirapine for the whole breasteeding period At every visit, give adherence counselling (Nurse and EC) for all patients newly initiated on cart. The mother s viral load should be rechecked every 6 months until baby is 2 years old.
PMTCT B+ - Standard Procedures for Postnatal and Child Welfare follow-up HIV + on combined ART HIV + mother not on ART, baby receiving NVP or nothing. Check Hb, U&E, LFT, urine, Staging, CD4, VL. HIV- or unknown do HIV test Do VL test at first post-natal visit HIV + do post-test counseling and enroll in pre-art care. Check Hb, U&E, LFT, urine, HIV- give post-test counseling. Repeat HIV test every 8 weeks during breastfeeding. Explain that she should start cart today. Start NVP syrup for baby Check HIV status of baby if due, and change baby to cart if positive Initiate ART (TDF-3TC-EFV) Enroll in ART register. Complete 6 weeks NVP syrup for baby (but change baby to cart if baby tests HIV+). Refer to EC for ART readiness counseling today continue to complete 3 counselling sessions (before or after initiation) Mother not ready to start ART today. Refer to EC for 1 st ART readiness counseling Book 2 nd appointment within 1 week. If patient does not attend counseling session, contact patient and book to see nurse. At 2 nd appointment, counsel patient on ART Mother now ready to initiate cart Give ongoing adherence support Counsel mother on importance of HIV test for infant at 12 and 18 months. Check mothers VL at 6, 12 and 18 month visits*. Mother not ready to initiate ART at 2 nd appt Continue NVP syrup for baby for breastfeeding period (but change baby to cart if baby is HIV+) Note: * Women in the PMTCT program should have a VL test at enrolment, at delivery and every 6 m thereafter. Any patient with detectable viral load after > 6 months on ART should be referred for stepped-up adherence counseling, according to the viral load monitoring algorithm. ᶧ Contraindications to TDF-3TC-EFV are summarized in the National ART Guidelines. If the woman has renal impairment, AZT-3TC-EFV can be given. If EFV intolerant, use NVP based regimens
HIV Exposed Infant Age 6 Weeks to 12 Months Perform DNA PCR test Give cotrimoxazole. NVP prophylaxis if BF and mom not on ART*. Encourage EBF for 6 mos, then BF plus complementary foods until at least 12 mos and safe to stop BF. For mother: check CD4 and offer family planning. DNA PCR POSITIVE Sick Child? Repeat DNA PCR if initial test was negative. Refer to doctor at any time if clinical suspicion of HIV. DNA PCR NEGATIVE Breastfed in the 6 weeks before testing? Child is HIV POSITIVE Refer to ARV clinic Continue cotrimoxazole Stop NVP prophylaxis Continue BF as long as possible For mother: check CD4 offer family planning Repeat DNA PCR or check viral load when baseline labs drawn YES Child is STILL EXPOSED Continue cotrimoxazole NVP prophylaxis if BF and mom not on ART* Encourage EBF for 6 mos, then BF plus complementary foods until at least 12 mos and safe to stop BF For mother: check CD4 and offer family planning Repeat HIV testing 6 weeks after cessation of BF NO Child is HIV NEGATIVE Stop cotrimoxazole Stop NVP prophylaxis* For mother: check CD4 and offer family planning Repeat Rapid Test at 18 months for confirmation *NVP prophylaxis should be stopped 1 week after BF cessation
HIV Exposed Child Age 12 to 18 Months Perform Rapid Test A Rapid test A POSITIVE Perform DNA PCR test Check CD4; Refer to ARV clinic Cont BF and reassess when DNA PCR result returns. Give cotrimoxazole. Cont NVP prophylaxis if BF and mom not on ART*. DNA PCR POSITIVE DNA PCR NEGATIVE Sick Child? Repeat Rapid Test and DNA PCR if initial test was negative. Refer to doctor at any time if clinical suspicion of HIV. Rapid Test A NEGATIVE Breastfed in the 2 months before testing? Breastfed in the 6 weeks before testing? YES NO YES NO Child is HIV POSITIVE Refer to ARV clinic Continue cotrimoxazole. Stop NVP prophylaxis. Continue BF as long as possible For mother: Check CD4 and. offer family planning Repeat DNA PCR or check viral load when baseline labs drawn Child is STILL EXPOSED Continue cotrimoxazole NVP prophylaxis if BF and mom not on ART*. Encourage BF and complementary foods until safe to stop BF. For mother: Check CD4 a offer FP family planning Repeat Rapid Test 2 months after cessation of BF Child is HIV NEGATIVE Stop cotrimoxazole. Stop NVP prophylaxis*. For mother: Check CD4 offer family planning. Repeat Rapid Test at 18 months for confirmation While awaiting DNA PCR results, immediate referral to ARV clinic is recommended due to a high likelihood of true infection. * NVP prophylaxis should be stopped 1 week after BF cessation
HIV Exposed Child Age 18 Months or Older Perform Rapid Test A Rapid Test A POSITIVE Perform Rapid Test B Sick Child? Repeat Rapid Test if initial test was negative. Refer to doctor at any time if clinical suspicion of HIV. Rapid Test B NEGATIVE Breastfed in the 2 months before testing? Rapid Test B POSITIVE Rapid Test B NEGATIVE YES NO INCONCLUSIVE Result Continue cotrimoxazole. Continue NVP prophylaxis if BF and mom not on ART*. Send blood sample to national lab as tie breaker For Mother: Check CD4 and offer for family planning. Child is HIV POSITIVE Refer to ARV clinic. Continue cotrimoxazole. Stop NVP. Continue BF as long as possible For Mother: Check CD4 and i offer for family planning. Child is STILL EXPOSED Continue cotrimoxazole. Continue NVP prophylaxis if BF and mom not on ART*. Encourage BF and complementary foods until safe to stop BF. For Mother: Check CD4 and i offer family planning. Repeat Rapid Testing 2 months after cessation of BF Child is HIV NEGATIVE Stop cotrimoxazole. Stop NVP prophylaxis*. For Mother: Check CD4 and offer for family planning. * NVP prophylaxis should be stopped 1 week after BF cessation