Clinical trial NCT06962592: Mentor Moms+ Study
Official 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+)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Alcohol Consumption
Keywords: pregnant
postpartum
HIV prevention
HIV treatment
Alcohol use
breastfeeding
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: San Diego State University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-05-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in alcohol use (objective)
timeFrame: From enrollment to the end of intervention period at 6 months
measure: Reduction in alcohol use (self-report)
timeFrame: From enrollment to the end of intervention period at 6 months
Secondary outcomes:
measure: PrEP Initiation
timeFrame: From enrollment to the end of intervention period at 6 months
measure: PrEP Adherence
timeFrame: From enrollment to the end of intervention period at 6 months
measure: ART Adherence
timeFrame: From enrollment to the end of intervention period at 6 months
measure: ART Adherence
timeFrame: From enrollment to the end of intervention period at 6 months
measure: HIV Viral Load
timeFrame: From enrollment to the end of intervention period at 6 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Saldanha Bay Municipality Clinic
state: Western Cape
Study officials:
References: