Mentor Moms+ Study
Recruiting · NCT06962592 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Los Angeles
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
2 locations listed.
- Saldanha Bay Municipality Clinic - Cape Town, Western Cape, South Africa
- Saldanha Bay Clinics - Saldanha Bay, Western Cape, South Africa