Clinical Trial

Mentor Moms+ Study

Study acronym: (MM+)
Recruiting
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Summary
The goal of this study is to adapt an existing evidence based intervention for use in pregnant and lactating people (PLP) who use alcohol. Through the pilot RCT, we aim to understand if tailored intervention, Mentor Mothers+, is effective in reducing alcohol use (primary outcome) and improving antiretroviral (PrEP or ART) adherence (secondary outcomes) among pregnant and breastfeeding women living with and without HIV in a community heavily burdened by this syndemic. The investigators will conduct an pilot randomized control trial in 100 pregnant women, recruited during antenatal care (ANC) visits within the Saldanha Bay Municipality clinic in Cape Town, South Africa. The RCT will involve the delivery of brief, individual motivational interviewing sessions provided by trained mentor mothers from the community who are on either PrEP (living without HIV) or ART (living with HIV) and who stopped or reduced alcohol use during pregnancy. The enrolled participants will be followed for a 6-month period spanning both pregnancy and postpartum stages.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-04-29; most recent amendment 2026-07-01.
Status change: Not Yet Recruiting → Recruiting 2025-10-30
Trial Details
NCT Number NCT06962592
Lead Sponsor University of California, Los Angeles
Collaborators: University of Cape Town, San Diego State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions HIV, Alcohol Consumption
Enrollment 100 participants
Start Date 2025-09-01
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-02