RecruitingNot ApplicableNCT06962592

Mentor Moms+ Study

A Community-based Adaptation of a Peer-led Intervention to Address Alcohol Use and HIV Risk in Pregnant Women in South Africa (Mentor Moms+)

Sponsor

University of California, Los Angeles

Enrollment

100 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Alcohol Consumption

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.

Eligibility

Sex: FEMALEMin Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study — called Mentor Moms+ — is testing a program to help pregnant women who drink alcohol reduce or stop alcohol use during pregnancy. A mentor (an experienced mother who has been through similar challenges) will provide peer support and guidance. The goal is to protect the health of both mothers and their babies. **You may be eligible if...** - You are 16 or older - You are currently pregnant - You have used alcohol in the past 2 months during this pregnancy - You live within 20 kilometers of the study facility - You are willing and able to consent to participate **You may NOT be eligible if...** - You do not meet the criteria listed above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMM+

Participants in both study arms will receive clinic-based HIV counseling, including urine tenofovir testing and biofeedback counseling on recent PrEP or ART use. Activities unique to women enrolled in the intervention arm include: Brief motivational interviewing sessions with a mentor mother focusing on 1) EtG testing and biofeedback on recent alcohol use, 2) counseling and mentorship on ways to reduce alcohol use.

BEHAVIORALEnhanced HIV attention control (eSOC)

Participants in the enhanced HIV attention control arm (comparison group) will attend a similar number of study visits within the same time frame as intervention participants (5-6 sessions during 6-month timeframe including both pregnancy and postpartum). Control arm sessions will consist of one-on-one educational counseling on HIV risk, partner HIV testing modalities, as well as conducting PrEP/ART urine assay testing followed by real-time in-clinic adherence counseling delivered privately (different from study nurses delivering PrEP/ART biofeedback in MM+ intervention arm to avoid contamination), all coinciding with routine ANC visits.