Mentor Moms+ Study

ConditionsHIV Alcohol Consumption

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

MM+
Behavioral
Participants in both study arms will receive clinic-based HIV counseling, including urine tenofovir testing and biofeedback counseling on recent PrEP or ART use. Activities unique to women enrolled in the intervention arm include: Brief motivational interviewing sessions with a mentor mother focusing on 1) EtG testing and biofeedback on recent alcohol use, 2) counseling and mentorship on ways to reduce alcohol use.
Enhanced HIV attention control (eSOC)
Behavioral
Participants in the enhanced HIV attention control arm (comparison group) will attend a similar number of study visits within the same time frame as intervention participants (5-6 sessions during 6-month timeframe including both pregnancy and postpartum). Control arm sessions will consist of one-on-one educational counseling on HIV risk, partner HIV testing modalities, as well as conducting PrEP/ART urine assay testing followed by real-time in-clinic adherence counseling delivered privately (different from study nurses delivering PrEP/ART biofeedback in MM+ intervention arm to avoid contamination), all coinciding with routine ANC visits.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: MM+ InterventionExperimental treatment 1 intervention

Group B: Enhanced HIV attention control (eSOC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Reduction in alcohol use (objective)

Reduced alcohol use following the intervention delivery, measured via:dried blood spot (DBS) testing of phosphatidylethanol (PEth) levels Alcohol consumption via PEth will be defined as \<20 ng/mL representing light or no consumption, \>20-\<200 ng/mL indicating consumption and ≥200ng/mL indicating significant or heavy recent alcohol use in past 21 days.

Time frame