Maternal Alcohol Reduction Intervention in South Africa [MaRISA]

Study Overview
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Brief Summary
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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.

Official Title
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Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa

Conditions
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Maternal; Alcohol Use, Affecting Fetus

Intervention / Treatment
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* Behavioral: Mobile incentive-based intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile incentive-based intervention<br>Contingent incentives on abstinence from alcohol; Text-based health promotion support | Behavioral: Mobile incentive-based intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Ethylglucuronide (EtG) Testing | Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking. | Baseline | 
| Urine Ethylglucuronide (EtG) Testing | Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking. | 6 weeks | 
| Urine Ethylglucuronide (EtG) Testing | Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking. | 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) and craving levels on a scale of 1 to 10 [not at all to extreme]). | 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) and craving levels on a scale of 1 to 10 [not at all to extreme]). | 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) and craving levels on a scale of 1 to 10 [not at all to extreme]). | 3 months | 
| The Treatment Acceptability/Adherence Scale (TAAS) | 10-item self-report questionnaire with a 7-point Likert-type scale (1 = Disagree strongly; 7 = Agree strongly). The score ranges from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated adherence | Baseline | 
| The Treatment Acceptability/Adherence Scale (TAAS) | 10-item self-report questionnaire with a 7-point Likert-type scale (1 = Disagree strongly; 7 = Agree strongly). The score ranges from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated adherence | 6 weeks | 
| The Treatment Acceptability/Adherence Scale (TAAS) | 10-item self-report questionnaire with a 7-point Likert-type scale (1 = Disagree strongly; 7 = Agree strongly). The score ranges from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated adherence | 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 |