Mentor Moms+ Study ((MM+))

University of California, Los Angeles (UCLA)

Status: Begins enrollment in 3 months

Conditions: Alcohol Consumption; HIV

Treatments: Behavioral: MM+; Behavioral: Enhanced HIV attention control (eSOC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06962592

R34AA030942 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

MM+ Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: MM+

Enhanced HIV attention control (eSOC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced HIV attention control (eSOC)