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NCT06962592Recruiting

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+)

Source: ClinicalTrials.gov · Last updated 2 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
8 Apr 2025
Start date
1 Sept 2025
Primary completion date
31 Aug 2027
Lead sponsor
University of California, Los Angeles
Diseases
HIV
NCT number
NCT06962592

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Sept 2025 to the primary completion date, 31 Aug 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Individuals not meeting the above criteria will be excluded.

Who the study is looking for

  • • ≥ 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.

Age in the registry: 16 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Saldanha Bay Municipality Clinic
Coordinator of this site? Confirm its status
Cape TownSouth AfricaNot yet recruiting
Saldanha Bay Clinics
Coordinator of this site? Confirm its status
Saldanha BaySouth AfricaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.