Multilevel strategies to end HIV for young couples in Cape Town: Study protocol for a cluster randomized trial.

Journal: PloS one

Volume: 19

Issue: 6

Year of Publication: 2024

Affiliated Institutions:  RTI International, Research Triangle Park, Durham, NC, United States of America. Mental Health, Alcohol, Substance Use and Tobacco Research Unit, South African Medical Research Council, Tygerberg, South Africa. RTI International, Washington, DC, United States of America. RTI International, Nairobi, Kenya. UCT Faculty of Health Sciences, Desmond Tutu Health Foundation, Observatory, Cape Town, South Africa.

Abstract summary 

This protocol presents a multilevel cluster randomized study in 24 communities in Cape Town, South Africa. The study comprises four specific aims. Aim 1, conducted during the formative phase, was to modify the original Couples Health CoOp (CHC) intervention to include antiretroviral therapy/pre-exposure prophylaxis (ART/PrEP), called the Couples Health CoOp Plus (CHC+), with review from our Community Collaborative Board and a Peer Advisory Board. Aim 1 has been completed for staging the trial. Aim 2 is to evaluate the impact of a stigma awareness and education workshop on community members' attitudes and behaviors toward young women and men who use AODs and people in their community seeking HIV services (testing/ART/PrEP) and other health services in their local clinics. Aim 3 is to test the efficacy of the CHC+ to increase both partners' PrEP/ART initiation and adherence (at 3 and 6 months) and to reduce alcohol and other drug use, sexual risk and gender-based violence, and to enhance positive gender norms and communication relative to HIV testing services (n = 480 couples). Aim 4 seeks to examine through mixed methods the interaction of the stigma awareness workshop and the CHC+ on increased PrEP and ART initiation, retention, and adherence among young women and their primary partners. Ongoing collaborations with community peer leaders and local outreach staff from these communities are essential for reaching the project's aims. Additionally, a manualized field protocol with regular training, fidelity checks, and quality assurance are critical components of this multilevel community trial for successful ongoing data collection. Trial registration. Clinicaltrials.gov Registration Number: NCT05310773. Pan African Trials: pactr.samrc.ac.za/ Registration Number: PACTR202205640398485.

Authors & Co-authors:  Wechsberg Wendee M WM Carney Tara T Browne Felicia A FA van der Drift Isa M IM Kline Tracy L TL Nyblade Laura L LL Ndirangu Jacqueline J Orrell Catherine C Bonner Courtney P CP Caron Emily E

Study Outcome 

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Statistics
Citations :  South African Community Epidemiology Network on Drug Use (SACENDU). Research Brief: Monitoring Alcohol, Tobacco and Other Drug Use Trends in South Africa (July 1996 –June 2018). 2019.
Authors :  10
Identifiers
Doi : e0305056
SSN : 1932-6203
Study Population
Male,Female
Mesh Terms
Humans
Other Terms
Study Design
Study Approach
Country of Study
South Africa
Publication Country
United States