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

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 discriminatio...

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Main Authors: Wechsberg, W.M., Browne, F.A., Ndirangu, J., Bonner, C.P., Minnis, A.M., Nyblade, L., Speizer, I.S., Howard, B.N., Myers-Franchi, Bronwyn, Ahmed, K.
Format: Journal Article
Language:English
Published: BMC 2020
Subjects:
Online Access:http://hdl.handle.net/20.500.11937/85663
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author Wechsberg, W.M.
Browne, F.A.
Ndirangu, J.
Bonner, C.P.
Minnis, A.M.
Nyblade, L.
Speizer, I.S.
Howard, B.N.
Myers-Franchi, Bronwyn
Ahmed, K.
author_facet Wechsberg, W.M.
Browne, F.A.
Ndirangu, J.
Bonner, C.P.
Minnis, A.M.
Nyblade, L.
Speizer, I.S.
Howard, B.N.
Myers-Franchi, Bronwyn
Ahmed, K.
author_sort Wechsberg, W.M.
building Curtin Institutional Repository
collection Online Access
description 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).
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spelling curtin-20.500.11937-856632021-10-21T00:24:26Z 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 Wechsberg, W.M. Browne, F.A. Ndirangu, J. Bonner, C.P. Minnis, A.M. Nyblade, L. Speizer, I.S. Howard, B.N. Myers-Franchi, Bronwyn Ahmed, K. Science & Technology Life Sciences & Biomedicine Public, Environmental & Occupational Health HIV Sexual and reproductive health (SRH) Stigma Health Policy Project Stigma and Discrimination-reduction training (HPP S&D) Clinic staff Young Women's Health CoOp (YWHC) Alcohol and drug use Gender-based violence Adaptation WOMAN-FOCUSED INTERVENTION PREEXPOSURE PROPHYLAXIS CAPE-TOWN HEALTH COOP PREGNANT-WOMEN SEX WORKERS USE DRUGS STIGMA RISK INFECTION 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). 2020 Journal Article http://hdl.handle.net/20.500.11937/85663 10.1186/s12889-020-09458-y English http://creativecommons.org/licenses/by/4.0/ BMC fulltext
spellingShingle Science & Technology
Life Sciences & Biomedicine
Public, Environmental & Occupational Health
HIV
Sexual and reproductive health (SRH)
Stigma
Health Policy Project Stigma and Discrimination-reduction training (HPP S&D)
Clinic staff
Young Women's Health CoOp (YWHC)
Alcohol and drug use
Gender-based violence
Adaptation
WOMAN-FOCUSED INTERVENTION
PREEXPOSURE PROPHYLAXIS
CAPE-TOWN
HEALTH COOP
PREGNANT-WOMEN
SEX WORKERS
USE DRUGS
STIGMA
RISK
INFECTION
Wechsberg, W.M.
Browne, F.A.
Ndirangu, J.
Bonner, C.P.
Minnis, A.M.
Nyblade, L.
Speizer, I.S.
Howard, B.N.
Myers-Franchi, Bronwyn
Ahmed, K.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Science & Technology
Life Sciences & Biomedicine
Public, Environmental & Occupational Health
HIV
Sexual and reproductive health (SRH)
Stigma
Health Policy Project Stigma and Discrimination-reduction training (HPP S&D)
Clinic staff
Young Women's Health CoOp (YWHC)
Alcohol and drug use
Gender-based violence
Adaptation
WOMAN-FOCUSED INTERVENTION
PREEXPOSURE PROPHYLAXIS
CAPE-TOWN
HEALTH COOP
PREGNANT-WOMEN
SEX WORKERS
USE DRUGS
STIGMA
RISK
INFECTION
url http://hdl.handle.net/20.500.11937/85663