Clinical trial NCT05319977: Maternal Alcohol Reduction Intervention in South Africa [MaRISA]
Official title: Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal; Alcohol Use, Affecting Fetus
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-04-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This application proposes to develop and test a technology-based behavioral intervention to address maternal alcohol use in South Africa (SA). SA reports the highest per capita rates of alcohol consumption in the world and has one of the world's highest rates of lifelong disorders called fetal alcohol spectrum disorders (FASD). Prenatal alcohol use is often associated with exposure to gender-based violence, and an increase in gender-based violence due to the uncertainty and economic impact of COVID-19 is of a major concern. Recent evidence also showed that alcohol use during lactation significantly compromises child development in children exposed to alcohol through breastfeeding, and the adverse effect of postpartum alcohol use while breastfeeding was independent of prenatal alcohol exposure. Average breastfeeding duration in SA is beyond 1 year, and over 40% of mothers with and without a history of prenatal drinking report alcohol use while breastfeeding. A community-based behavioral intervention involving case management helps reduce prenatal alcohol use but is labor intensive, challenging the feasibility of widespread implementation in economically disadvantaged communities especially during the COVID-19 pandemic with limited social contact. An efficacious behavioral intervention to reduce alcohol use during pregnancy and lactation needs to be developed that is acceptable and feasible in economically disadvantaged communities, for women with transportation difficulties, or during the COVID-19 pandemic with limited social contact. The proposed intervention will incorporate mobile breathalyzer technology, contingent financial incentives, and text-based health promotion and referrals on gender-based violence, maternal infant health, and psychosocial issues including the impact of COVID-19 in the context of maternal alcohol use. Specific aims are (1) to develop and pretest a technology-based behavioral intervention to help women abstain from alcohol use during pregnancy and lactation via formative qualitative research with women who are pregnant or breastfeeding with a recent history of alcohol use, clinic and community stakeholders, and an established Community Collaborative Board in Cape Metropole, SA, and (2) to examine the acceptability and feasibility of the intervention on alcohol use during pregnancy and lactation by pilot testing the mobile technology-based platform with 60 women who are pregnant or postpartum. Acceptability will be assessed at follow-ups, and feasibility will include recruitment capability, process measures, and intervention outcomes. With the evidence of acceptability and feasibility of the proposed intervention, a large randomized clinical trial will become essential to establish efficacy of the intervention. The potential settings that can remotely incorporate the proposed behavioral intervention include primary care clinics, substance use treatment programs, and publicly funded programs for maternal/infant populations in SA, the United States, and other countries.


Eligibility criteria: Inclusion Criteria:

* Pregnant (≤28 ges wks) or postpartum (≤3 mos)
* Have reported alcohol use during the current pregnancy or lactation
* Positive for alcohol use by urinalysis
* Have their own mobile phone
* Intend to breastfeed for 6 months
* Voluntarily consent

Exclusion Criteria:

* Participated in focus group discussions or pretesting will not be eligible for pilot testing
* Serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month

Primary outcomes:
measure: Urine Ethylglucuronide (EtG) Testing
timeFrame: Baseline
measure: Urine Ethylglucuronide (EtG) Testing
timeFrame: 6 weeks
measure: Urine Ethylglucuronide (EtG) Testing
timeFrame: 3 months
measure: Self-reported Recent Drinking With Timeline Followback
timeFrame: Baseline
measure: Self-reported Recent Drinking With Timeline Followback
timeFrame: 6 weeks
measure: Self-reported Recent Drinking With Timeline Followback
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: South African Medical Research Council
Study officials:
References: