Clinical trial Recruiting at 1 site Interventional Ages 16 and up Women only

Mentor Mothers+ support program for pregnant and breastfeeding people who use alcohol

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

Run by University of California, Los Angeles · NCT06962592 · Data updated 2026-11-12

This trial will test whether Mentor Mothers+—brief motivational sessions delivered by trained local mothers—can reduce alcohol use and improve PrEP or ART adherence among pregnant and breastfeeding people who use alcohol in Cape Town.

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Quick facts

Study typeInterventional
Ages16 Years and up
SexWomen only
Enrollment100 (estimated)
SponsorUniversity of California, Los Angeles
Academic / other
Locations2 sites (Cape Town, Western Cape and 1 other locations)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedAugust 31, 2027
Study endsAugust 31, 2027
Registry record updatedJuly 2, 2026
Trial IDNCT06962592 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are pregnant people aged 16 or older who report alcohol use during pregnancy, live within about 20 kilometers of the Saldanha Bay clinics, and are willing to provide informed consent and attend follow-up visits.

Probably not a fit

People who are not pregnant, who do not use alcohol, live outside the catchment area, or who need specialized treatment for severe substance use disorders may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Mentor Mothers+ pilot is a randomized controlled trial enrolling 100 pregnant people who reported alcohol use, recruited during antenatal care at clinics in Saldanha Bay, Cape Town. Participants are randomized to receive either the MM+ intervention—brief individual motivational interviewing sessions delivered by trained mentor mothers who previously reduced alcohol use and are on PrEP or ART—or an enhanced HIV attention control. Primary and secondary outcomes are measured at six months, with alcohol use assessed by phosphatidylethanol (PEth) and PrEP/ART continuation by urine tenofovir levels. The study examines feasibility and acceptability of adapting the evidence-based mentor mother model to reduce alcohol use while supporting HIV prevention and treatment in a high-burden community.

Why it matters

Potential benefit: If successful, this approach could lower prenatal alcohol exposure and improve PrEP/ART adherence, reducing maternal and infant HIV risk and improving maternal-child health.

How similar studies have gone: The mentor mother model is an established evidence-based approach for improving HIV and antenatal care outcomes, but adapting it specifically to reduce alcohol use in pregnant and lactating people is a novel application being piloted.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* • ≥ 16 years;

  * Pregnancy confirmed;
  * reported alcohol use during pregnancy (in last 2 months);
  * lives within 20 kilometers of the study facility;
  * able and willing to consent to study participation.

Exclusion Criteria:

* Individuals not meeting the above criteria will be excluded.

Where it's running

  • Saldanha Bay Clinics
    Saldanha Bay, Western Cape, South Africa
    Recruiting
  • Saldanha Bay Municipality Clinic
    Cape Town, Western Cape, South Africa
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.