| NCT ID | NCT06962592 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-09-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06962592 clinical trial?
This trial is open to female participants only, aged 16 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06962592 currently recruiting?
Yes, NCT06962592 is actively recruiting participants. Contact the research team at dvoradavey@ucla.edu for enrollment information.
Where is the NCT06962592 trial being conducted?
This trial is being conducted at Cape Town, South Africa, Saldanha Bay, South Africa.
Who is sponsoring the NCT06962592 clinical trial?
NCT06962592 is sponsored by University of California, Los Angeles. The trial plans to enroll 100 participants.
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