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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA029048 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical Research Council, South Africa | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile incentive-based intervention | Experimental | Contingent incentives on abstinence from alcohol; Text-based health promotion support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African Medical Research Council | Cape Town | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40734177 | Derived | 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. |
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After the main findings are published, we welcome other researchers who want to analyze the data in other ways.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Incentive-based Intervention | Contingent incentives on abstinence from alcohol; Text-based health promotion support 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Incentive-based Intervention | Contingent incentives on abstinence from alcohol; Text-based health promotion support 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urine Ethylglucuronide (EtG) Testing | Number and proportion of participants who were tested negative of alcohol use in urine samples. | Posted | Count of Participants | Participants | Baseline |
|
|
3 months per participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobile Incentive-based Intervention | Contingent incentives on abstinence from alcohol; Text-based health promotion support 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neonatal death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Neonatal death occurred, and counseling was offered to the participant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intoxication | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yukiko Washio | RTI International | 9194852794 | ywashio@rti.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2021 | Aug 13, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2021 | Aug 21, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2021 | Jun 27, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Urine Ethylglucuronide (EtG) Testing | Number and proportion of participants who were tested negative of alcohol use in urine samples. | Posted | Count of Participants | Participants | 6 weeks |
|
|
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| Primary | Urine Ethylglucuronide (EtG) Testing | Number and proportion of participants who were tested negative of alcohol use in urine samples. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | the number of standard drinks per day | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | the number of standard drinks per day | 6 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | the number of standard drinks per day | 3 months |
|
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|
| 0 |
| 60 |
| 5 |
| 60 |
| 2 |
| 60 |
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| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Abscesses on breasts | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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