Mentor Mothers+ support program for pregnant and breastfeeding people who use alcohol
A Community-based Adaptation of a Peer-led Intervention to Address Alcohol Use and HIV Risk in Pregnant Women in South Africa (Mentor Moms+)
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 2 sites (Cape Town, Western Cape and 1 other locations) |
| Trial ID | NCT06962592 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cape Town, Western Cape and 1 other locations
- Saldanha Bay Municipality Clinic — Cape Town, Western Cape, South Africa (Not_yet_recruiting)
- Saldanha Bay Clinics — Saldanha Bay, Western Cape, South Africa (Recruiting)
Study contacts
- Study coordinator: Dvora L Joseph Davey, PhD
- Email: dvoradavey@ucla.edu
- Phone: 310-701-1526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.