Mentor Moms+ Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16+
SponsorUniversity of California, Los Angeles

About this trial

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

Qualifiers

• ≥ 16 years;

Pregnancy confirmed;

reported alcohol use during pregnancy (in last 2 months);

lives within 20 kilometers of the study facility;

Disqualifiers

Individuals not meeting the above criteria will be excluded.

Trial design

Treatments tested in this trial

  • MM+
  • Enhanced HIV attention control (eSOC)

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, Los Angeles

Lead sponsor

University of Cape Town

Collaborator

San Diego State University

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator