Maternal Alcohol Reduction Intervention in South Africa [MaRISA]

Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa

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.

Study Overview

• Status: Completed
• Conditions: Maternal; Alcohol Use, Affecting Fetus
• Intervention / Treatment: Behavioral: Mobile incentive-based intervention

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • South African Medical Research Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile incentive-based intervention; Contingent incentives on abstinence from alcohol; Text-based health promotion support	Behavioral: Mobile incentive-based intervention; a technology-based behavioral intervention to address maternal alcohol use with mobile breathalyzer technology or/and urinalysis for biochemical verification of alcohol use, contingent financial incentives on alcohol abstinence, and text-based health promotion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Ethylglucuronide (EtG) Testing	Number and proportion of participants who were tested negative of alcohol use in urine samples.	Baseline
Urine Ethylglucuronide (EtG) Testing	Number and proportion of participants who were tested negative of alcohol use in urine samples.	6 weeks
Urine Ethylglucuronide (EtG) Testing	Number and proportion of participants who were tested negative of alcohol use in urine samples.	3 months
Self-reported Recent Drinking With Timeline Followback	Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.	Baseline
Self-reported Recent Drinking With Timeline Followback	Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.	6 weeks
Self-reported Recent Drinking With Timeline Followback	Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant weight (g)	The measure will be based on medical records and postpartum assessment.	At a postpartum timepoint during the study period of 3 months
Infant height (cm)	The measure will be based on medical records and postpartum assessment.	At a postpartum timepoint during the study period of 3 months
Infant head circumference (cm)	The measure will be based on medical records.	At a postpartum timepoint during the study period of 3 months
Gestational weeks at birth	The measure will be based on medical records.	At a postpartum timepoint during the study period of 3 months

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Medical Research Council, South Africa

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 0217974; R21AA029048 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the main findings are published, we welcome other researchers who want to analyze the data in other ways.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No