Mentor Moms+ Study

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.

Conditions

• HIV
• Alcohol Consumption

Interventions

BEHAVIORAL

MM+

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.

BEHAVIORAL

Enhanced 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.

Sponsors & Collaborators

• University of Cape Town

  collaborator OTHER

• San Diego State University

  collaborator OTHER

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of California, Los Angeles

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• South Africa

Study Locations