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\u2014study protocol

Andrew Medina-Marino,Charl Bezuidenhout,Millicent Atujuna,Connie L Celum,Dana Bezuidenhout,Francesca Little,Joseph Daniels,Linda-Gail Bekker,Ruanne V Barnabas,Phuti Ngwepe,Remco P.H Peters,Sybil Hosek

doi:10.1186/s13063-021-05402-6

Abstract

BackgroundHIV 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.MethodsWe 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.DiscussionThis 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 registrationClinicalTrials.govNCT03977181. Registered on 6 June 2019—retrospectively registered.

Highlights

human immunodeficiency virus (HIV) incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP)
We propose a mixed-methods study among Adolescent girls and young women (AGYW) aged 16–25 years in Eastern Cape Province, South Africa
Costs and scalability of service platforms and interventions will be evaluated. This will be the first study to assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW

Summary

Introduction

HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). There is an urgent need for effective HIV prevention strategies targeted at young women and under their control, to reduce HIV incidence among this key population. Pre-exposure prophylaxis (PrEP) with emtricitabine (FTC)/tenofovir (TDF) as a method of HIV prevention has demonstrated significant efficacy in clinical trials among different population groups, with efficacy being strongly associated with increased drug adherence [14,15,16,17,18]. Previous and current PrEP demonstration projects have largely focused on providing PrEP through clinic-based delivery platforms, including antiretroviral therapy (ART), sexually transmitted infections (STI), family planning, and adolescent-friendly clinics [19,20,21]. While clinic-based services may provide good opportunity for service integration, leveraging these facility-based services for PrEP provision may be fraught with barriers including perceived lack of confidentiality and privacy at health centres [22,23,24], unfriendly clinic staff [25, 26], long queues, inconvenient operating hours, and a perceived predominant focus on maternal-child health with no AGYW-focused services [27, 28]

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