Community-Based Adaptation and Evaluation of a Peer-Led Intervention to Address Alcohol Use and HIV in Pregnant and Breastfeeding Women in South Africa: Protocol for the "Mentor Mothers Plus" Randomized Control Trial.

backgroundIn South Africa, pregnant and lactating women (PLW) face a dual burden of high alcohol use and HIV prevalence, both of which adversely affect maternal and infant health. However, few interventions address alcohol use and HIV risk concurrently in this population.

objectiveThis study seeks to adapt and pilot-test in a randomized controlled trial (RCT) the peer-led multisession intervention Mentor Mothers Plus (MM+) to integrate alcohol reduction strategies with HIV prevention and care support (in a seroneutral intervention) among PLW in Saldanha Bay, Western Cape, South Africa.

methodsUsing the ADAPT-ITT (assessment, decision, adaptation, production, topical experts, integration, training, testing) framework, we adapted the evidence-based Mentor Mother (MM) model, originally aimed at reducing vertical HIV transmission among mothers with HIV. Our mixed methods design includes (1) qualitative research, including in-depth interviews (IDIs) and focus group discussions (FGDs), to assess drivers of perinatal alcohol use and HIV risk; (2) intervention adaptation through community-based participatory workshops with stakeholders to refine the MM+ intervention in order to include culturally and contextually strategies; and (3) a pilot RCT with 100 pregnant women (≥16 years old, reporting recent alcohol use) randomized in a 1:1 ratio to the MM+ intervention (motivational interviewing [MI], including HIV and alcohol reduction messaging) or enhanced standard of care (SOC). Primary RCT outcomes include reduced alcohol use, via phosphatidylethanol (PEth) blood levels at 6-month follow-up. Secondary outcomes include uptake and adherence to pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) among women with HIV, as well as intervention fidelity, feasibility, and acceptability.

resultsCommunity research included 2 FGDs with health workers (n=6) and community leaders (n=7) and 31 interviews with partners and peers of PLW. Data showed that women are motivated to reduce alcohol use for child health but face barriers (eg, misconceptions about safety of alcohol use, poverty, trauma, and intimate partner violence [IPV]). Alcohol use is with friends/family members/partners and tied to financial stress, unplanned pregnancy, and poor mental health. MM+ support preferences emphasize nonjudgmental, peer-based mentorship, family involvement, and faith/community engagement. Gaps include stigma around HIV and contraceptive services. Communities recommend mentor mothers with lived experience, providing culturally relevant, empathetic support, and linking to social and clinical services. In August 2025, a community workshop refined the intervention, emphasizing the need for trustworthy mentor mothers with lived experience. Priorities included culturally relevant information on alcohol use, HIV prevention, family planning, trauma and interpersonal violence support, and flexible delivery. Next steps involve finalizing materials, training mentor mothers, and launching the RCT.

conclusionsOur community-based, participatory study, MM+, offers a promising approach to address co-occurring alcohol use and HIV among PLW. Stakeholder engagement enhances contextual relevance and supports future scalability. The RCT will evaluate efficacy of the model in reducing alcohol and improving HIV outcomes.

trial registrationClinicaltrials.gov NCT06962592; https://clinicaltrials.gov/study/NCT06962592. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/78856.