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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

Authors
  • Wechsberg, Wendee M.1, 2, 3, 4
  • Browne, Felicia A.1, 2
  • Ndirangu, Jacqueline1
  • Bonner, Courtney Peasant1
  • Minnis, Alexandra M.5, 6
  • Nyblade, Laura7
  • Speizer, Ilene S.2
  • Howard, Brittni N.1
  • Myers, Bronwyn8
  • Ahmed, Khatija9
  • 1 RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA , Research Triangle Park (United States)
  • 2 University of North Carolina Gillings School of Global Public Health, 135 Dauer Drive, Chapel Hill, NC, 27599, USA , Chapel Hill (United States)
  • 3 North Carolina State University, 640 Poe Hall, Raleigh, NC, 27695, USA , Raleigh (United States)
  • 4 Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC, 27710, USA , Durham (United States)
  • 5 RTI International, 2150 Shattuck Avenue, Suite 800, Berkeley, CA, 94704, USA , Berkeley (United States)
  • 6 University of California, 2121 Berkeley Way, Room 5302, Berkeley, CA, 94720, USA , Berkeley (United States)
  • 7 RTI International, 701 13th Street NW #750, Washington, DC, 20005, USA , Washington (United States)
  • 8 Medical Research Council Francie van Zijl Drive, Parow Valley, Cape Town, South Africa , Cape Town (South Africa)
  • 9 Setshaba Research Centre, 2088 Block H, Soshanguve, 0152, South Africa , Soshanguve (South Africa)
Type
Published Article
Journal
BMC Public Health
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Sep 15, 2020
Volume
20
Issue
1
Identifiers
DOI: 10.1186/s12889-020-09458-y
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundDespite 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov. Identifier: NCT04048551 (Recruiting). Registered: August 7, 2019 (Retrospectively registered).

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