Mentor Moms+ Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое MM+
  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.
• Поведенческое Enhanced HIV attention control (eSOC)
  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 (dif

Первичные конечные точки

• Reduction in alcohol use (objective) [Срок оценки: From enrollment to the end of intervention period at 6 months]
• Reduction in alcohol use (self-report) [Срок оценки: From enrollment to the end of intervention period at 6 months]

Вторичные конечные точки (5)

• PrEP Initiation [Срок оценки: From enrollment to the end of intervention period at 6 months]
• PrEP Adherence [Срок оценки: From enrollment to the end of intervention period at 6 months]
• ART Adherence [Срок оценки: From enrollment to the end of intervention period at 6 months]
• ART Adherence [Срок оценки: From enrollment to the end of intervention period at 6 months]
• HIV Viral Load [Срок оценки: From enrollment to the end of intervention period at 6 months]

Критерии участия

Критерии включения

• • ≥ 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.

Критерии исключения

• Individuals not meeting the above criteria will be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

ЮАР · 2 центра

• Saldanha Bay Municipality Clinic — Cape Town
• Saldanha Bay Clinics — Saldanha Bay

Публикации

• 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

Идентификаторы

NCT: NCT06962592 · 24-0130 · R34AA030942

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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