Actively Recruiting

Phase Not Applicable
Age: 16Years +
FEMALE
Healthy Volunteers
ID06962592

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

Led by University of California, Los Angeles · Updated on 2026-04-13

100

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

U

University of Cape Town

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a peer-led intervention called Mentor Mothers+ designed to help pregnant and breastfeeding women who use alcohol and are living with or without HIV. This pilot randomized control trial aims to see if the tailored Mentor Mothers+ intervention can reduce alcohol use and improve adherence to antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) in a community heavily affected by these health challenges. The study involves 100 pregnant women recruited during antenatal care visits in South Africa. The study compares two groups: the Mentor Mothers+ intervention group and an enhanced HIV attention control group. Women in the Mentor Mothers+ group receive brief motivational interviewing sessions by trained mentor mothers who themselves are on PrEP or ART and have reduced or stopped alcohol use during pregnancy. These sessions, delivered over six months through clinic visits during pregnancy and postpartum, focus on reducing alcohol use and supporting HIV prevention or treatment adherence. The control group receives educational counseling and adherence support with similar visit frequency but without the motivational interviewing component. Both groups undergo testing for alcohol use and PrEP or ART adherence. Participants will be followed for six months, spanning pregnancy and postpartum stages. Researchers will assess alcohol use reduction through laboratory measures and self-reports, and monitor PrEP and ART adherence using urine tests and counseling feedback. The study will also track HIV viral load to evaluate health outcomes. The trial includes multiple clinic visits for counseling, testing, and support to help understand the intervention's effects on alcohol use and HIV-related care adherence.

CONDITIONS

Brief Title

Mentor Moms+ Study

Who Can Participate

Age: 16Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 16 years or older
  • Confirmed pregnancy
  • Reported alcohol use during pregnancy within the last 2 months
  • Lives within 20 kilometers of the study facility
  • Able and willing to consent to participate in the study
Not Eligible

You will not qualify if you...

  • Individuals not meeting the above inclusion criteria will be excluded

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 6 months

Participants receive behavioral interventions aimed at reducing alcohol use and supporting HIV prevention and treatment during pregnancy and postpartum. This includes motivational interviewing sessions with a mentor mother for those in the intervention arm, or educational counseling and adherence support in the control arm, integrated with routine antenatal care visits.

5 to 6 sessions over 6 months during pregnancy and postpartum

Trial Site Locations

Total: 2 locations

1

Saldanha Bay Municipality Clinic

Cape Town, Western Cape, South Africa

Not Yet Recruiting

2

Saldanha Bay Clinics

Saldanha Bay, Western Cape, South Africa

Actively Recruiting

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Research Team

D

Dvora L Joseph Davey, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

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.

Zaynab Essack, Zaino Petersen, Amanda P Miller...

https://pubmed.ncbi.nlm.nih.gov/41411648