Maternal; Alcohol Use, Affecting FetusNCT05319977
Maternal Alcohol Reduction Intervention in South Africa [MaRISA]
A study testing Mobile incentive-based intervention in people with Maternal; Alcohol Use, Affecting Fetus, run by RTI International at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal; Alcohol Use, Affecting Fetus
- What is being tested?
- Mobile incentive-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Africa
- Study dates
- 5 Mar 2021to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Maternal; Alcohol Use, Affecting Fetus
- Being tested
- Mobile incentive-based intervention
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile incentive-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile incentive-based intervention | Experimental | Contingent incentives on abstinence from alcohol; Text-based health promotion support Receives: Behavioral: Mobile incentive-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Ethylglucuronide (EtG) Testing
Number and proportion of participants who were tested negative of alcohol use in urine samples.
Measured: Baseline
Urine Ethylglucuronide (EtG) Testing
Number and proportion of participants who were tested negative of alcohol use in urine samples.
Measured: 6 weeks
Urine Ethylglucuronide (EtG) Testing
Number and proportion of participants who were tested negative of alcohol use in urine samples.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start5 Mar 2021
- Primary completion1 Jul 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal; Alcohol Use, Affecting FetusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Yukiko Washio, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319977
- Sponsor's protocol ID
- 0217974
- Other IDs
- R21AA029048
- Status last verified
- Aug 2024
- First submitted
- 15 Mar 2022
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the main findings are published, we welcome other researchers who want to analyze the data in other ways.
Publications
Erasmus-Claassen LA, Mpisane N, Petersen Williams P, Browne FA, Myers B, Wechsberg WM, Parry CDH, Taylor SN, Washio Y. Participant experiences with a text message and contingency management intervention for alcohol use during pregnancy and lactation in Cape Town, South Africa. Addict Sci Clin Pract. 2025 Jul 29;20(1):59. doi: 10.1186/s13722-025-00594-7.
PubMed 40734177
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa
- ClinicalTrials.gov ID
- NCT05319977
- Acronym / sponsor ID
- 0217974
- Conditions
- Maternal; Alcohol Use, Affecting Fetus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile incentive-based intervention | Experimental | Behavioral: Mobile incentive-based interventionContingent incentives on abstinence from alcohol; Text-based health promotion support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile incentive-based interventiona 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. | Behavioural | Mobile incentive-based intervention |
Primary outcome
Urine Ethylglucuronide (EtG) Testing
Time frame: Baseline
Number and proportion of participants who were tested negative of alcohol use in urine samples.
Urine Ethylglucuronide (EtG) Testing
Time frame: 6 weeks
Number and proportion of participants who were tested negative of alcohol use in urine samples.
Urine Ethylglucuronide (EtG) Testing
Time frame: 3 months
Number and proportion of participants who were tested negative of alcohol use in urine samples.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40734177Erasmus-Claassen LA, Mpisane N, Petersen Williams P, Browne FA, Myers B, Wechsberg WM, Parry CDH, Taylor SN, Washio Y. Participant experiences with a text message and contingency management intervention for alcohol use during pregnancy and lactation in Cape Town, South Africa. Addict Sci Clin Pract. 2025 Jul 29;20(1):59. doi: 10.1186/s13722-025-00594-7.
- Individual participant dataSharing planned: Yes. After the main findings are published, we welcome other researchers who want to analyze the data in other ways.
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Recruiting
The Oklahoma Parent-Child Assistance Program
Substance Use Disorders, Pregnancy Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile incentive-based intervention in people with Maternal; Alcohol Use, Affecting Fetus, run by RTI International at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Ethylglucuronide (EtG) Testing (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.