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NCT Number: NCT06962592

Mentor Moms+ Study

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.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saldanha Bay Municipality Clinic, Cape Town, Western Cape, South Africa

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About this study

The syndemic of alcohol use and HIV risk in pregnant and lactating people (PLP) threatens the health of mother, fetus, children and families in South Africa. PLP living with HIV who use alcohol may access antiretroviral therapy (ART) late or disengage with ART care, increasing the risk of vertical HIV transmission. PLP not living with HIV who use alcohol are at increased risk of HIV and may require targeted interventions to receive pre-exposure prophylaxis (PrEP) delivery and adherence counselling. Alcohol use also increases risk of HIV acquisition and poor ART adherence. The "mentor mother" (MM) intervention model is an evidence-based intervention (EBI) with demonstrated success in improving HIV and antenatal care outcomes. The model utilizes a task-shifting approach; positive deviant peers (mothers) deliver interventions to PLP within and outside of the antenatal clinic.

Our study aims to evaluate the feasibility and acceptability of MM+ on reduction of alcohol use (primary outcome) and PrEP use (in PLP without HIV) and ART adherence (in PLP living with HIV) (secondary outcomes) in a pilot randomized control trial (RCT) in n=100 pregnant women who currently use alcohol. Primary outcome: Reduced alcohol use following the intervention (at 6m via phosphatidylethanol [PEth] levels). Secondary outcomes: PrEP and ART continued use at 6 months via urine tenofovir levels at 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Reduction in alcohol use (objective)

    Time frame: From enrollment to the end of intervention period at 6 months

    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.

  2. Reduction in alcohol use (self-report)

    Time frame: From enrollment to the end of intervention period at 6 months

    Reduced alcohol use following the intervention delivery,measured via: self-report (AUDIT-C score).

    Self-reported alcohol use (via participant survey) will be categorically defined via AUDIT-C score of 0 indicating abstinence versus score >0 indicating recent alcohol use.

Secondary outcomes

  1. PrEP Initiation

    Time frame: From enrollment to the end of intervention period at 6 months

    Initiation to PrEP evaluated via patient medical records

  2. PrEP Adherence

    Time frame: From enrollment to the end of intervention period at 6 months

    Adherence to PrEP evaluated via urine tenofovir testing results

  3. ART Adherence

    Time frame: From enrollment to the end of intervention period at 6 months

    Adherence to ART measured via urine tenofovir (TFV) testing results. Urine TFV results will reflect recent ART adherence (past 48-72 hours).

  4. ART Adherence

    Time frame: From enrollment to the end of intervention period at 6 months

    Adherence to ART measured via participant self-report

  5. HIV Viral Load

    Time frame: From enrollment to the end of intervention period at 6 months

    HIV viral load levels will be evaluated among participants living with HIV and on ART

Study contacts

Contact information is provided by the study sponsor or research team.

Dvora L Joseph Davey, PhD

CONTACT

[email protected]

310-701-1526

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • San Diego State University
  • University of Cape Town

Registry information

Official study title

A Community-based Adaptation of a Peer-led Intervention to Address Alcohol Use and HIV Risk in Pregnant Women in South Africa (Mentor Moms+)

Acronym: (MM+)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 8, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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