The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol

Abstract

Background HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers to clinic-based sexual and reproductive health services. Even when AGYW access PrEP as an HIV prevention method, poor prevention-effective use was a serious barrier to achieving its optimal HIV prevention benefits. Determining the acceptability and feasibility of community-based platforms to increase AGYW’s access to PrEP, and evaluating behavioural interventions to improve prevention-effective use of PrEP are needed. Methods We propose a mixed-methods study among AGYW aged 16–25 years in Eastern Cape Province, South Africa. In the first component, a cross-sectional study will assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to refer HIV-negative, at-risk AGYW to non-clinic-based, same-day PrEP initiation services. In the second component, we will enrol 480 AGYW initiating PrEP via our CBCT platforms into a three-armed (1:1:1) randomized control trial (RCT) that will evaluate the effectiveness of adherence support interventions to improve the prevention-effective use of PrEP. Adherence will be measured over 24 months via tenofovir-diphosphate blood concentration levels. Qualitative investigations will explore participant, staff, and community experiences associated with community-based PrEP services, adherence support activities, study implementation, and community awareness. Costs and scalability of service platforms and interventions will be evaluated. Discussion This will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW. Trial registration ClinicalTrials.govNCT03977181. Registered on 6 June 2019—retrospectively registered.

Incremental costs of integrated PrEP provision and effective use counselling in community‐based platforms for adolescent girls and young women in South Africa: an observational study

“…Medically eligible (HIV negative, not pregnant and creatinine clearance > 60 ml/minute) AGYW screened for HIV potential exposure behavioural factors and interested in taking PrEP were randomized to receive (1) community‐based medication dispensary of PrEP refills (control arm – standard‐of‐care PrEP provision and monitoring in South Africa with passive adherence support), (2) group‐based health clubs effective use counselling and medication dispensary or (3) individual effective use counselling with medication dispensary. Detailed information about the control and intervention arms is available in the study protocol [16].…”

“…These benefits increase the yield of linking both HIV-negative and HIVpositive individuals to prevention and treatment services [15]. [16].…”

“…The University of Cape Town Human Research Ethics Committee approved a waiver for guardian proxy consent for minors who opted not to involve parents via the Ministerial Consent for Non-Therapeutic Research with Minors. The study protocol [16] was reviewed and approved by the University of Cape Town Research Ethics Committee with respect to scientific content and compliance applicable to research and human subjects' regulations. The Community PrEP study is registered with ClinicalTrials.gov (NCT03977181) and is available at https://clinicaltrials.gov/ct2/show/NCT03977181.…”

“These Girls Have a Chance to be the Future Generation of HIV Negative”: Experiences of Implementing a PrEP Programme for Adolescent Girls and Young Women in South Africa

“…Early on in the grant implementation period, each principal grant recipient (PR) developed provincial priority population in South Africa's National Strategic Plan (NSP) for curbing HIV, TB and STIs: 2017-2022. There is an urgent need for effective female-initiated HIV prevention strategies targeted at AGYW, to reduce HIV incidence among this population [3].…”

“…South Africa's human immunodeficiency virus (HIV) epidemic is both the largest in the world, and also the fastest growing [1,2]. There exist significant differences in HIV incidence and prevalence by age and sex; women face disproportionate HIV burden throughout the life cycle, but this gender disparity is most pronounced among adolescent girls and young women (AGYW) aged 15-24 years, whose HIV prevalence is 3.3 times greater than their male peers (15.5% compared to 4.8%) [3][4][5]. South Africa's epidemiological profile shows that while new HIV infections do occur in adolescent girls below 15 years, incidence is substantially higher in the 15-24 age group, given that the majority (92.4%) of AGYW have their sexual debut at 15 or older [4].…”