Mentor Moms+ Study

NCT06962592 | Recruiting DMC

• 2 other identifiers: 24-0130R34AA030942
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Alcohol Consumption

Keywords

pregnant; postpartum; HIV prevention; HIV treatment; Alcohol use; breastfeeding

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of intervention period at 6 months

• Reduction in alcohol use (self-report)

  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.

  From enrollment to the end of intervention period at 6 months

Secondary Outcomes (5)

• PrEP Initiation

  From enrollment to the end of intervention period at 6 months

• PrEP Adherence

  From enrollment to the end of intervention period at 6 months

• ART Adherence

  From enrollment to the end of intervention period at 6 months

• ART Adherence

  From enrollment to the end of intervention period at 6 months

• HIV Viral Load

  From enrollment to the end of intervention period at 6 months

Study Arms (2)

MM+ Intervention

EXPERIMENTAL

MM+ will involve mentor mother delivery of brief MI sessions individually over a series of clinic- based visits over a 6m period during pregnancy and postpartum. Intervention content, duration, and full menu of HIV prevention services offered will be finalized prior to launch. We anticipate no fewer than five to six 15-20 minute MI sessions focused on the benefits of reducing alcohol use during pregnancy, managing HIV risk among women without HIV and importance of ART use and viral suppression for reducing the risk of vertical transmission. Participants in MM+ arm will receive enhanced HIV prevention counseling integrated into routine antenatal care visits, including PrEP and ART biofeedback adherence counseling, provided by a trained study nurse. Participants in the intervention arm will also receive EtG testing (alcohol use) and corresponding biofeedback counseling.

Behavioral: MM+

Enhanced HIV attention control (eSOC)

ACTIVE COMPARATOR

Similar to placebo pills, attention control is often used in randomized trials for behavioral interventions to control for the nonspecific effects of the intervention. Given that existing MM models focus on prevention of vertical transmission and HIV treatment and our primary interest is understanding how inclusion of alcohol reduces alcohol use improves adoption of ART/PrEP use, we will use an enhanced HIV attention control with the same time frame for the intervention (e.g. 2-3 sessions during antenatal/and 2-3 sessions during postpartum periods). Sessions will consist of educational counseling on HIV risk, partner testing modalities as well as PrEP/ART urine assay testing followed by real-time in-clinic adherence counseling delivered privately by lay counselors (different from MM+ arm to avoid contamination), all coinciding with routine ANC visits when possible.

Behavioral: Enhanced HIV attention control (eSOC)

Interventions

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.

MM+ Intervention

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.

Enhanced HIV attention control (eSOC)

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• Individuals not meeting the above criteria will be excluded.

Sponsors & Collaborators

• University of Cape Town: collaborator
• University of California, Los Angeles: lead
• San Diego State University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

Saldanha Bay Municipality Clinic

Cape Town, Western Cape, South Africa

NOT YET RECRUITING

Saldanha Bay Clinics

Saldanha Bay, Western Cape, South Africa

RECRUITING

Related Publications (1)

• Essack Z, Petersen Z, Miller AP, Schoetz Dean S, Daniels D, Hofmeester H, Belin T, van Rooyen H, Louw J, Joseph Davey D. Community-Based Adaptation and Evaluation of a Peer-Led Intervention to Address Alcohol Use and HIV in Pregnant and Breastfeeding Women in South Africa: Protocol for the "Mentor Mothers Plus" Randomized Control Trial. JMIR Res Protoc. 2025 Dec 18;14:e78856. doi: 10.2196/78856.

  PMID: 41411648 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Breast Feeding

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Feeding Behavior

Central Study Contacts

Dvora L Joseph Davey, PhD

CONTACT

310-701-1526; dvoradavey@ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: For the pilot RCT, we will randomize enrolled, consented participants into one of two study arms, MM+ intervention or enhanced HIV attention control, in a 1:1 ratio.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year following study start through 1 year following study end
• Access Criteria: Email PI with full request: dvoradavey@ucla.edu

Locations

ZA (2)