Maternal Alcohol Reduction Intervention in South Africa [MaRISA]
Primary Purpose
Maternal; Alcohol Use, Affecting Fetus
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Mobile incentive-based intervention
Sponsored by

About this trial
This is an interventional treatment trial for Maternal; Alcohol Use, Affecting Fetus
Eligibility Criteria
Inclusion Criteria:
- To be eligible, women must (1) be pregnant (≤28 ges wks) or postpartum (≤3 mos), (2) have reported alcohol use during the current pregnancy or lactation, (3) be positive for prenatal alcohol use by urinalysis, (4) have their own mobile phone (>80% of the target population owns a mobile phone), (5) intend to breastfeed for 6 months, (6) be either Black African or Coloured, and (7) voluntarily consent.
Exclusion Criteria:
- Women who participated in focus group discussions or pretesting will not be eligible for pilot testing.
- Women who reported serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month will not be eligible and will be provided with necessary referrals.
Sites / Locations
- South African Medical Research Council
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile incentive-based intervention
Arm Description
Contingent incentives on abstinence from alcohol; Text-based health promotion support
Outcomes
Primary Outcome Measures
Urine Ethylglucuronide (EtG) Testing
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
Urine Ethylglucuronide (EtG) Testing
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
Urine Ethylglucuronide (EtG) Testing
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
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"]).
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"]).
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"]).
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
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
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
Secondary Outcome Measures
Infant weight (g)
The measure will be based on medical records and postpartum assessment.
Infant height (cm)
The measure will be based on medical records and postpartum assessment.
Infant head circumference (cm)
The measure will be based on medical records.
Gestational weeks at birth
The measure will be based on medical records.
Full Information
NCT ID
NCT05319977
First Posted
March 15, 2022
Last Updated
August 10, 2023
Sponsor
RTI International
Collaborators
Medical Research Council, South Africa
1. Study Identification
Unique Protocol Identification Number
NCT05319977
Brief Title
Maternal Alcohol Reduction Intervention in South Africa [MaRISA]
Official Title
Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RTI International
Collaborators
Medical Research Council, South Africa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal; Alcohol Use, Affecting Fetus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile incentive-based intervention
Arm Type
Experimental
Arm Description
Contingent incentives on abstinence from alcohol; Text-based health promotion support
Intervention Type
Behavioral
Intervention Name(s)
Mobile incentive-based intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urine Ethylglucuronide (EtG) Testing
Description
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
Time Frame
Baseline
Title
Urine Ethylglucuronide (EtG) Testing
Description
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
Time Frame
6 weeks
Title
Urine Ethylglucuronide (EtG) Testing
Description
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
Time Frame
3 months
Title
Self-reported recent drinking with timeline followback
Description
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"]).
Time Frame
Baseline
Title
Self-reported recent drinking with timeline followback
Description
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"]).
Time Frame
6 weeks
Title
Self-reported recent drinking with timeline followback
Description
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"]).
Time Frame
3 months
Title
The Treatment Acceptability/Adherence Scale (TAAS)
Description
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
Time Frame
Baseline
Title
The Treatment Acceptability/Adherence Scale (TAAS)
Description
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
Time Frame
6 weeks
Title
The Treatment Acceptability/Adherence Scale (TAAS)
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Infant weight (g)
Description
The measure will be based on medical records and postpartum assessment.
Time Frame
At a postpartum timepoint during the study period of 3 months
Title
Infant height (cm)
Description
The measure will be based on medical records and postpartum assessment.
Time Frame
At a postpartum timepoint during the study period of 3 months
Title
Infant head circumference (cm)
Description
The measure will be based on medical records.
Time Frame
At a postpartum timepoint during the study period of 3 months
Title
Gestational weeks at birth
Description
The measure will be based on medical records.
Time Frame
At a postpartum timepoint during the study period of 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant (≤28 ges wks) or postpartum (≤3 mos)
Have reported alcohol use during the current pregnancy or lactation
Positive for prenatal 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
Facility Information:
Facility Name
South African Medical Research Council
City
Cape Town
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After the main findings are published, we welcome other researchers who want to analyze the data in other ways.
Learn more about this trial
Maternal Alcohol Reduction Intervention in South Africa [MaRISA]
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