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Completed

NCT Number: NCT05319977

Maternal Alcohol Reduction Intervention in South Africa [MaRISA]

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.

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Key information

Conditions

Maternal; Alcohol Use, Affecting Fetus Alcohol Drinking Behavior Drinking Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South African Medical Research Council

Cape Town, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile incentive-based intervention

Behavioral

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 outcomes

  1. Urine Ethylglucuronide (EtG) Testing

    Time frame: Baseline

    Number and proportion of participants who were tested negative of alcohol use in urine samples.

  2. Urine Ethylglucuronide (EtG) Testing

    Time frame: 6 weeks

    Number and proportion of participants who were tested negative of alcohol use in urine samples.

  3. Urine Ethylglucuronide (EtG) Testing

    Time frame: 3 months

    Number and proportion of participants who were tested negative of alcohol use in urine samples.

  4. Self-reported Recent Drinking With Timeline Followback

    Time frame: Baseline

    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.

  5. Self-reported Recent Drinking With Timeline Followback

    Time frame: 6 weeks

    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. Self-reported Recent Drinking With Timeline Followback

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • Medical Research Council, South Africa
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 11, 2022
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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