Integration of HIV pre-exposure prophylaxis (PrEP) services for pregnant and breastfeeding women in eight primary care clinics: results of an implementation science study.

Background: Although HIV vertical transmission (VT) has declined significantly in sub-Saharan Africa, incident HIV infection in pregnant and postpartum women is estimated to account for roughly one-third of VT. Oral pre-exposure prophylaxis (PrEP) for pregnant and breastfeeding women (PBFW) is part of the recommended guidelines in South Africa since 2021; however, integration of PrEP services within antenatal (ANC) and postnatal care (PNC) remains limited. Methods: Between March 2022 and September 2023, we evaluated the acceptability, feasibility and sustainability of integrating PrEP for PBFW in high-HIV prevalence clinics after training and mentoring health care providers (HCP). We used the Reach Effectiveness-Adoption Implementation Maintenance (RE-AIM) framework to evaluate the intervention. Acceptability and maintenance were defined as the proportion of PBFW without HIV who initiated PrEP and the proportion of women continuing PrEP at 3 months in ANC or PNC services. Feasibility was defined as the proportion of trained HCPs (HIV lay counsellors and nurses/ midwives) who provided PrEP according to national guidelines, measured through post-training surveys and in-service assessments. Sustainability was defined as number of facilities and providers that continued to provide PrEP for PBFW past the mentoring period. Results: In 8 facilities providing ANC and PNC, we trained 224 HCP (127 nurses and 37 counsellors). Of those, we mentored 60 nurses, midwives and HIV counsellors working with PBFW, with 72% of nurse/midwives and 65% of counsellors scoring over 8/10 on the final mentoring assessment Overall, 12% (1493/12,614) of HIV-negative pregnant women started PrEP and 41% of those continued PrEP at 3-months. Among the HIV-negative breastfeeding women in postnatal care, 179/1315 (14%) initiated PrEP and 25% continued PrEP at 3-months. All 8 facilities continued providing PrEP 3-months after handover of the clinics. Conclusion: Integration of PrEP services in ANC and services for breastfeeding women was feasible, acceptable and sustainable. Acceptability and PrEP continuation showed improvement over time. Barriers to the PrEP integration were observed including the lack of regular HIV testing of breastfeeding mothers and need for ART-trained nurses to prescribe PrEP. Enablers included motivated and dedicated staff.

Postnatal clubs: Implementation of a differentiated and integrated model of care for mothers living with HIV and their HIV-exposed uninfected babies in Cape Town, South Africa.

BACKGROUND: Despite the overall reduction in the HIV mother-to-child transmission (MTCT) rate in South Africa, poor adherence and retention in care during breastfeeding contribute to this period being a major driver of MTCT in South Africa. To improve this retention, postnatal clubs were created as an integrated, differentiated model of care providing psychosocial support and comprehensive care for the mother-infant pairs (MIP), including HIV and under-5-child services. We describe the implementation of these facility-based clubs and examine its health outcomes in a peri-urban primary health care setting in Cape Town, South Africa. METHODS: In this prospective cohort study, conducted between June 2016 and December 2019, MIPs were recruited into postnatal clubs between 6 weeks and 6 months of age and followed-up until 18 months of age. Outcomes including maternal Viral Load (VL), and children's HIV testing were compared to a historical control group. Children's immunizations and maternal sexual and reproductive health outcomes are also described. RESULTS: During the implementation of the postnatal club study period, 484 MIP were recruited with 84% overall attendance, 95% overall viral load suppression, and 98% overall uptake of HIV infant testing. Compared to historical controls, the club infant rapid test uptake was 1.6 times higher (95% CI: 1.4-1.9) at 9 months and 2.0 times higher at 18 months (95% CI: 1.6-2.6). Through 12 months and between 12-18 months, maternal VL monitoring was higher in the club group compared to the historical control by 1.5 times (95% CI: 1.3-1.6) and 2.6 times (95% CI: 2.1-3.2), respectively, with similar maternal VL suppression. Of 105 infants attending the 12 months visit, 99% were fully vaccinated by one year. CONCLUSION: MIP in the postnatal clubs showed better PMTCT outcomes than historical controls with high levels of retention in care. Other outcomes such as immunisation results suggest that integration of services, such as in the postnatal club, is feasible and beneficial for MIPs.

An analysis of the HIV testing cascade of a group of HIV-exposed infants from birth to 18 months in peri-urban Khayelitsha, South Africa.

BACKGROUND: Despite the reduction of HIV mother-to-child transmission, there are concerns regarding transmission rate in the breastfeeding period. We describe the routine uptake of 6 or 10 (6/10) weeks, 9 months and 18 months testing, with and without tracing, in a cohort of infants who received HIV PCR testing at birth (birth PCR) (with and without point of care (POC) testing) in a peri-urban primary health care setting in Khayelitsha, South Africa. METHODS: In this cohort study conducted between November 2014 and February 2018, HIV-positive mothers and their HIV-exposed babies were recruited at birth and all babies were tested with birth PCR. Results of routine 6/10 weeks PCR, 9 months and 18 months testing were followed up by a patient tracer. We compared testing at 6/10 weeks with a subgroup from historical cohort who was not tested with birth PCR. RESULTS: We found that the uptake of 6/10 weeks testing was 77%, compared to 82% with tracing. When including all infants in the cascade and comparing to a historical cohort without birth testing, we found that infants who tested a birth were 22% more likely to have a 6/10 weeks test compared to those not tested at birth. There was no significant difference between the uptake of 6/10 weeks testing after birth PCR POC versus birth PCR testing without POC. Uptake of 9 months and 18 months testing was 39% and 24% respectively. With intense tracing efforts, uptake increased to 45% and 34% respectively. CONCLUSION: Uptake of HIV testing for HIV-exposed uninfected infants in the first 18 months of life shows good completion of the 6/10 weeks PCR but suboptimal uptake of HIV testing at 9 months and 18 months, despite tracing efforts. Birth PCR testing did not negatively affect uptake of the 6/10 weeks HIV test compared to no birth PCR testing.

Delivering PrEP to Young Women in a Low-Income Setting in South Africa: Lessons for Providing Both Convenience and Support.

Daily oral pre-exposure prophylaxis (PrEP) is a key tool in addressing high HIV incidence among young women, and breaking the cycle of transmission. From 2017 to 2020, Médecins Sans Frontières (MSF) offered PrEP, in conjunction with contraception and risk-reduction counselling, to women aged 18-25, in a government-run clinic in Khayelitsha, a low income high HIV prevalence area in South Africa. Drawing on clinical, quantitative, and qualitative interview data, we describe participants' experiences and engagement with the PrEP program, participant adherence (measured by TFV-DP levels in dried blood spots) over time, and the indirect benefits of the PrEP program. Of 224 screened and eligible participants, 164 (73.2%) initiated PrEP, with no large differences between those who initiated and those who did not. Overall, 47 (29%) completed 18 months follow-up, with 15 (9.1%) attending all visits. 76 (46.9%) participants were lost to follow-up, 15 (9.1%) exited when leaving the area, and 28.7% of exits happened in the first month of the study. We identified two different trajectories of PrEP adherence: 67% of participants had, on average, consistently low TFV-DP levels, with the remaining 33% having sustained high adherence. Few baseline characteristics predicted good adherence. The main reported barrier to taking PrEP was forgetting to take or travel with the pills. Encouragement from others declined as a reported facilitator from month 6 to 18 (family: 93.1% vs 77.6%, p = 0.016, friends: 77.6% vs 41.4%, p ≤ 0.001, partners: 62.1% vs 46.6%, p = 0.096, other PrEP users: 89.7% vs 74.1%, p = 0.020). Disclosure to friends and family in some cases opened dialogue around sex, and helped to educate others about PrEP. Self-reported sex with more than one partner, and sex without a condom, decreased significantly after enrolment (p < 0.001, p = 0.063). In the individual interviews, participants credited their PrEP experience with changing their behaviour. Recognising the challenges with, but overall benefits from a package of care that includes the option of PrEP, lessons drawn from this study can help maximise persistence on PrEP within resource constraints. PrEP providers need to address participants' need for both convenience and social support.

Knowledge transmission, peer support, behaviour change and satisfaction in post Natal clubs in Khayelitsha, South Africa: a qualitative study.

BACKGROUND: The Post Natal Club (PNC) model assures comprehensive care, including HIV and Maternal and Child Health care, for postpartum women living with HIV and their infants during an 18-month postnatal period. The PNC model was launched in 2016 in Town Two Clinic, a primary health care facility in Khayelitsha, South Africa. This qualitative research study aims to understand how participation in PNCs affected knowledge transmission, peer support, behaviour change and satisfaction with the care provided. METHODS: We conducted ten in-depth interviews; three focus group discussions and participant observation with PNC members, health-care workers and key informants selected through purposive sampling. Seventeen PNC members between 21 and 38 years old, three key informants and seven staff working in PNC participated in the research. All participants were female, except for one of the three key informants who was male. Data was collected until saturation. The data analysis was performed in an inductive way and involved an iterative process, using Nvivo11 software. RESULTS: PNC members acquired knowledge on HIV, ART, adherence, infant feeding, healthy eating habits, follow up tests and treatment for exposed infants. Participants believed that PNC created strong relationships among members and offered an environment conducive to sharing experience and advice. Most interviewees stated that participating in PNC facilitated disclosure of their HIV status, enhanced support network and provided role models. PNC members said that they adapted their behaviour based on advice received in PNCs related to infant feeding, ART adherence, monitoring of symptoms and stimulation of early childhood development. The main benefits were believed to be comprehensive care for mother-infant pairs, time-saving and the peer dynamic. The main challenge from the perspective of key informants was the sustainability of dedicating human resources to PNC. CONCLUSION: The PNC model was believed to improve knowledge acquisition, behaviour change and peer support. Participants, staff and the majority of key informants expressed a high level of satisfaction with the PNC model. Sustainability and finding adequate human resources for PNCs remained challenging. Strategies to improve sustainability may include handing over some PNC tasks to members to increase their sense of ownership.

The last and first frontier--emerging challenges for HIV treatment and prevention in the first week of life with emphasis on premature and low birth weight infants.

INTRODUCTION: There is new emphasis on identifying and treating HIV in the first days of life and also an appreciation that low birth weight (LBW) and preterm delivery (PTD) frequently accompany HIV-related pregnancy. Even in the absence of HIV, PTD and LBW contribute substantially to neonatal and infant mortality. HIV-exposed and -infected infants with these characteristics have received little attention thus far. As HIV programs expand to meet the 90-90-90 target for ending the HIV pandemic, attention should focus on newborn infants, including those delivered preterm or of LBW. DISCUSSION: In high prevalence settings, infant diagnosis of HIV is usually undertaken after the neonatal period. However, as in utero infection may be diagnosed at birth, earlier initiation of therapy may limit viral replication and prevent early damage. Globally, there is growing awareness that preterm and LBW infants constitute a substantial proportion of births each year. Preterm infants are at high risk for vertical transmission. Feeding difficulties, apnoea of prematurity and vulnerability to sepsis occur commonly. Feeding intolerance, a frequent occurrence, may compromise oral administration of medications. Although there is growing experience with post-exposure prophylaxis for HIV-exposed term newborn infants, there is less experience with preterm and LBW infants. For treatment, there are even fewer options for preterm infants. Only zidovudine has adequate dosing recommendations for treating term and preterm infants and has an intravenous formulation, essential if feeding intolerance occurs. Nevirapine dosing for prevention, but not treatment, is well established for both term and preterm infants.HIV diagnosis at birth is likely to be extremely stressful for new parents, more so if caring for preterm or LBW infants. Programs need to adapt to support the medical and emotional needs of young infants and their parents, where interventions may be lifesaving. CONCLUSIONS: New focus is required for the newborn baby, including those born preterm, with LBW or small for gestational age to consolidate gains already made in early diagnosis and treatment of young children.