The PrEpare Pretoria Project

Protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa

Dados Bibliográficos

ID15358798
AutoresW M Wechsberg (0000-0002-5146-6463, University of North Carolina at Chapel Hill, autor correspondente), F A Browne (0000-0002-4230-2096, University of North Carolina at Chapel Hill), Jacqueline Ndirangu (0000-0001-8346-7359, RTI International), Courtney Peasant Bonner (0000-0001-6983-2698, RTI International), Alexandra M Minnis (0000-0002-2943-2005, RTI International), Laura Nyblade (0000-0001-8067-4192, RTI International), Ilene S Speizer (0000-0001-6204-1316, University of North Carolina at Chapel Hill), Brittni N Howard (0000-0002-2111-1143, RTI International), Bronwyn Myers (0000-0003-0235-6716, South African Medical Research Council), Khatija Ahmed (0000-0003-0309-1641, Setshaba Research Centre)
Ano2020
Volume20
Fascículo1
Data de publicação2020-09-15
Peer ReviewedSim
Open AccessSim
TipoARTICLE
PeriódicoBMC Public Health (JOURNAL)
Identificadores do periódicoISSN: 1471-2458 • E-ISSN: 1471-2458
EditoraBioMed Central (PUBLISHER • GB)
DOI10.1186/s12889-020-09458-y
OpenAlexW3085498999
IdiomaEN
Citações recebidas10
Referências citadas49

Background Despite increased prevention efforts, HIV remains the leading cause of death among adolescent girls and young women in South Africa. Although research indicates important determinants of HIV acquisition at the individual and interpersonal levels, structural-level stigma and discrimination continue to be critical barriers to reaching and retaining this key population for HIV prevention and sexual and reproductive health services. Innovative and multilevel interventions are needed that can address the intersectional structural and gender issues that young women face, including stigma, alcohol and drug use, gender-based violence, and other risk factors when seeking health services. Oral pre-exposure prophylaxis (PrEP) taken daily has been found to be an effective biomedical HIV prevention tool. Testing a comprehensive gender-focused biobehavioral HIV prevention intervention that is inclusive of social ecological determinants, such as stigma and discrimination reduction in clinics, is critical for reducing HIV among adolescent girls and young women. Methods This project involves both a Community Collaborative Board and a Youth Advisory Board in helping to adapt the Young Women’s Health CoOp intervention and the Health Policy Project (HPP) Stigma and Discrimination (S&D) reduction training curriculum to the setting and population. This study uses a two-by-two factorial design with stratified randomization of 12 clinics, each with distinct catchment areas. The Young Women’s Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health. Adolescent girls and young women will be assessed with behavioral and biological measures at baseline, 3-, 6- and 9-month follow-up. The S&D reduction training is provided for all staff in the clinics randomized to this condition. Clinic staff will be surveyed at baseline, 4- and 8-month follow-up. We will recruit 900 AGYW from communities in the 12 clinic catchment areas. Discussion The study findings, if efficacious across the outcomes, will be incorporated into the gender-focused HIV prevention intervention toolkit and disseminated to inform multilevel prevention approaches. Trial registration ClinicalTrials.gov. Identifier: NCT04048551 (Recruiting). Registered: August 7, 2019 (Retrospectively registered)

Alternative medicine · Biostatistics · Cluster (spacecraft · Environmental health · Family medicine · Human immunodeficiency virus (HIV · Pathology · Protocol (science · Public health · Randomized controlled trial · Research design · HIV-related health complications and treatments · HIV/AIDS Impact and Responses · HIV/AIDS Research and Interventions · Medicine · Nursing · Epidemiology · Internal Medicine · Surgery