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

Trials

Ruanne V. Barnabas¹  Connie L. Celum¹  Joseph Daniels²  Francesca Little³  Sybil Hosek⁴  Dana Bezuidenhout⁵  Remco P.H. Peters⁵  Phuti Ngwepe⁵  Charl Bezuidenhout⁵  Andrew Medina-Marino⁶  Millicent Atujuna⁷  Linda-Gail Bekker⁷ 

[1] Department of Global Health, University of Washington, Seattle, WA, USA;Department of Epidemiology, University of Washington, Seattle, WA, USA;Department of Psychiatry and Human Behaviors, Charles R. Drew University of Medicine and Science, Los Angeles, USA;Department of Statistical Sciences, University of Cape Town, Cape Town, South Africa;Division of Child and Adolescent Psychiatry, Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA;Research Unit, Foundation for Professional Development, 10 Rochester Rd, Vincent, East London, Buffalo City Metro, Eastern Cape Province, South Africa;Research Unit, Foundation for Professional Development, 10 Rochester Rd, Vincent, East London, Buffalo City Metro, Eastern Cape Province, South Africa;The Desmond Tutu HIV Centre, University of Cape Town, Anzio Road, Observatory, Cape Town, South Africa;Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA;The Desmond Tutu HIV Centre, University of Cape Town, Anzio Road, Observatory, Cape Town, South Africa;

关键词: HIV;    HIV prevention;    PrEP;    Randomized controlled trial;    Adolescent girls and young women;    Community-based delivery platforms;    Adherence support intervention;    Cost-effectiveness;    South Africa;   

DOI  :  10.1186/s13063-021-05402-6

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY