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

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.

Outcomes of substance use and sexual power among adolescent girls and young women in Cape Town: Implications for structural and cultural differences.

Adolescent girls and young women (AGYW) in South Africa experience contextual barriers to HIV risk reduction including incomplete schooling, unintended pregnancy, substance use, and gender-based violence. A cluster randomised trial in Cape Town allocated 24 Black and Coloured communities to a gender-focused HIV risk-reduction intervention or HIV testing, with 500 AGYW total enrolled. We evaluated intervention efficacy by comparing mean differences overall, by community population group (Black and Coloured) and among those with structural barriers based on neighbourhood, education, and employment (n = 406). Both arms reported reductions in alcohol, cannabis, and condomless sex, with no intervention efficacy overall. Among AGYW with barriers, intervention participants reported fewer days of methamphetamine use at 6 months (t(210) = 2·08, p = ·04). In population group analysis, we found intervention effects on alcohol and sexual communication. Intervention participants in Black communities had fewer days of alcohol use at 12 months (t(136) = 2·10, p = ·04). Sexual discussion (t(147) = -2·47, p = ·02) and condom negotiation (t(146) = -2·51, p = ·01) increased for intervention participants at 12 months in Coloured communities. Gender-focused interventions must address population group differences and intersecting barriers to decrease substance use and increase education, skills, and sexual health protection.

'We have goals but [it is difficult]'. Barriers to antiretroviral therapy adherence among women using alcohol and other drugs living with HIV in South Africa.

BACKGROUND: Women living with HIV who misuse alcohol and live in economically disadvantaged settings in South Africa experience a multitude of contextual barriers as they navigate the HIV care continuum. The Women's Health CoOp (WHC), a brief, woman-focused, behavioural, evidence-based intervention, has been shown to be effective in reducing heavy drinking and improving HIV-related outcomes among this key population. However, these women face other broader socioecological barriers to antiretroviral therapy (ART) adherence. METHODS: The WHC was implemented in a modified, stepped-wedge implementation science trial in public health clinics and substance use treatment programmes in Cape Town, South Africa. A qualitative substudy was conducted to explore barriers to HIV treatment adherence among women enrolled in this trial. Eight focus group discussions were conducted with 69 participants 6 months after completion of the WHC workshops. Focus groups were audio-recorded (with consent), transcribed verbatim and analysed using a thematic approach. RESULTS: The mean age of the participants was 33 years and the mean self-reported number of drinks per day was 13. The main contextual factors influencing participants' ART adherence were intrapersonal-level factors (substance use, financial constraints, food insecurity; community-level factors (anticipated and enacted stigma, community violence) and institutional-level factors (patient-provider relationships, health facility barriers, environmental stigma). CONCLUSION: Comprehensive interventions addressing the contextual barriers and unique challenges faced by women who misuse alcohol in low-resource settings that intersect with HIV treatment nonadherence should be implemented in tandem with successful biobehavioural HIV interventions for long-term effectiveness and sustainability. PATIENT OR PUBLIC CONTRIBUTION: Our South African community collaborative board has been involved throughout this study; participants and clinic staff voices have been essential in our interpretation of these findings.

mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina.

BACKGROUND: Disparities in the prevalence of HIV persist in the southern United States, and young African American women have a disproportionate burden of HIV as compared with young women of other racial/ethnic backgrounds. As a result, engaging young African American women in the HIV care continuum through HIV testing is imperative. This study is designed to reach this key population at risk for HIV. The study seeks to test the efficacy of two formats of a gender-focused, evidence-based, HIV-risk reduction intervention-the Young Women's CoOp (YWC)-relative to HIV counseling and testing (HCT) among young African American women between the ages of 18 and 25 who use substances and have not recently been tested for HIV. METHODS: Using a seek-and-test framework, this three-arm cross-over randomized trial is being conducted in three county health departments in North Carolina. Each county is assigned to one of three study arms in each cycle: in-person (face-to-face) YWC, mobile Health (mHealth) YWC, or HCT. At study enrollment, participants complete a risk behavior survey via audio computer-assisted self-interview, and drug, alcohol, and pregnancy screening tests, and are then referred to HIV, gonorrhea, and chlamydia testing through their respective health departments. Participants in either of the YWC arms are asked to return approximately 1 week later to either begin the first of two in-person individual intervention sessions or to pick up the mHealth intervention preloaded on a tablet after a brief introduction to using the app. Participants in all arms are asked to return for a 6-month follow-up and 12-month follow-up, and repeat the survey and biological testing from baseline. DISCUSSION: The findings from this study will demonstrate which delivery format (mHealth or face-to-face) is efficacious in reducing substance use and sexual risk behaviors. If found to be efficacious, the intervention has potential for wider dissemination and reach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02965014 . Registered November 16, 2016.