Browsing by Subject "Pre-exposure prophylaxis"

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    Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
    (2021-11-06) Miner, Maurine D; Bekker, Linda-Gail; Kredo, Tamara; Bhagwandin, Niresh; Corey, Lawrence; Gray, Glenda E
    A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the World Health Organization for persons at high risk of acquiring HIV, but not all countries immediately adopted those recommendations. The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to SoC and PrEP in HIV prevention clinical trials taking place in lower- to middle-income countries (LMIC). Policymakers, regulators, ethicists, experts in law, researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. A group of subject matter experts presented on the regulatory, ethical, scientific, and historic framework of SoC in clinical trials, focusing on PrEP in South Africa. Summit participants discussed how and when to include new HIV treatment and prevention practices into existing clinical guidelines and trial protocols, as well as the opportunities for and challenges to scaling up interventions. The summit addressed challenges to PrEP provision, such as inconsistent efficacy amongst different populations and various biological, virological, and immunological explanations for this heterogeneity. Advocates and community members propagated the urgent need for accessible interventions that could avert HIV infection. The meeting recommended supporting access to PrEP in HIV prevention trials by (1) developing PrEP access plans for HIV vaccine trials, (2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism, and (3) supporting the safety monitoring of PrEP. This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials.
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    Oral PrEP use among pregnant or parenting young women in South Africa: evidence from a large community-based implementation study
    (2026) Chen-Charles, Jenny Davey, Dvora J. Rousseau, Elzette Little, Francesca Toska, Elona Mathola, Ntombovuyo Macdonald, Pippa Vanto, Onesimo Wallace, Melissa Bekker, Linda-Gail; Davey, Dvora J; Rousseau, Elzette; Little, Francesca; Toska, Elona; Mathola, Ntombovuyo; Macdonald, Pippa; Vanto, Onesimo; Wallace, Melissa; Bekker, Linda-Gail, Melissa
    Abstract Background The risk of HIV acquisition is heightened during pregnancy and early parenthood with the additional risk of vertical HIV transmission. While recent studies have improved our understanding of PrEP use among pregnant and breastfeeding women, further evidence is needed to inform the design of interventions that support sustained use, especially among young women who are pregnant or parenting. Methods We analysed data from young women aged 15–29 years who initiated PrEP in an implementation study (FastPrEP) in Cape Town, South Africa. Logistic regression was used to examine the association between pregnancy or parenting status (≥ 1 living child) and PrEP discontinuation at 1- and 4-months post-initiation, based on pharmacy refill data. The primary exposure was currently pregnant or having a child (vs. not); secondary analyses stratified by age (15–24 vs. 25–29 years) among women who were pregnant/parenting. Models were adjusted for age and hypothesised explanatory factors were included in sensitivity analysis: service delivery location, contraceptive use, HIV risk perception, and relationship status. Results Between August 2022 and June 2024 n = 4,876 young women initiated PrEP; 44% were pregnant/parenting (of which 10% were pregnant), and the median age was 21.6 years (IQR:18–25). At 1-month, women who were pregnant/parenting had higher odds of PrEP discontinuation (aOR:1.30, 95% CI:1.14–1.49). At 4-months this relationship persisted (aOR:1.41, 95% CI:1.12–1.78) compared with non-pregnant/parenting women. Among those pregnant/parenting, younger women (15–24 years) had higher odds of discontinuation at 1-month (aOR:1.31, 95% CI:1.08–1.58) and 4-months (aOR:1.41, 95%CI:1.02–1.96) compared to women aged 25–29. In the fully adjusted multivariable model, receiving PrEP in mobile clinics (aOR:0.71, 95% CI:0.61–0.82) vs. government clinics was associated with lower odds of early discontinuation. Conclusion Young women who are pregnant/parenting face elevated risk of early PrEP discontinuation. Differentiated, life-stage and youth-responsive interventions, such as counselling, partner involvement, and integration with maternal and child health, or sexual and reproductive health services, are critical to improving PrEP persistence among this priority population. This population should be prioritised in the rollout of long-acting PrEP formulations, which may better align with their needs and reduce the burden of daily adherence.
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    Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial
    (2022-07-07) Joseph Davey, Dvora L.; Dovel, Kathryn; Cleary, Susan; Khadka, Nehaa; Mashele, Nyiko; Silliman, Miriam; Mvududu, Rufaro; Nyemba, Dorothy C.; Coates, Thomas J.; Myer, Landon
    Background HIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women’s engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use. Methods Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation. Discussion This study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting. Trial registration NCT05322629 : Date of registration: April 12, 2022.