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| Name | Class |
|---|---|
| Medical Research Council, South Africa | OTHER |
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South Africa (SA) has a long history of social and health disparities, resulting in the world's highest rate of fetal alcohol spectrum disorder (FASD; 111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. FASD is completely preventable if women do not drink during pregnancy. Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and cannabis. The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone. Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate the likelihood of alcohol-induced birth defects.
Data from Cape Metropole, SA, showed that all women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis use. Alcohol use while breastfeeding also occurs at a relatively high rate in SA. Despite tremendous health benefits from breastfeeding,maternal alcohol use while breastfeeding significantly compromises infant development. Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use in the United States (U.S.). The Women's Health CoOp (WHC) is an evidence-based brief intervention addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol use. These evidence-based interventions need to be combined and adapted for addressing maternal polysubstance use and associated health and behavioral issues during pregnancy and lactation in SA. The Specific Aims are as follows: (1) R61 Aim 1- Conduct formative qualitative research with women who are pregnant or breastfeeding with a recent history of polysubstance use, clinic and community stakeholders, and an established Community Collaborative Board. (2) R61 Aim 2-Test feasibility, acceptability, and appropriateness of the adapted intervention with 48 women (24 pregnant and 24 breastfeeding) in Cape Metropole, SA. (3) R33 Aim 1-Examine the effectiveness of the adapted intervention (i.e., CM and text-based support with WHC educational components) in a 2-group randomized controlled trial with 184 women who are pregnant and follow up during pregnancy and 3 months postpartum. (4) R33 Aim 2-Examine the impact on gestational, birth, and infant outcomes. (5) R33 Aim 3-Track cost and conduct preliminary cost-effectiveness analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components |
|
| Usual Care | Active Comparator | Community treatment referrals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention with contingent incentives and text-based support | Behavioral | Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG) | An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking. The dipstick testing will have ≥300 ng/mL as a cutoff value. | 3-month postpartum |
| Number of Participants With Negative Urinalysis for Nicotine Metabolite (Cotinine) | Biochemical verification of recent tobacco use in urine samples. A tobacco metabolite (cotinine) will be measured in urine samples. The metabolite can be detected up to 3-4 days after use. The dipstick testing will have ≥200 ng/mL as a cutoff value. | 3-month postpartum |
| Number of Participants With Negative Urinalysis for Cannabis Metabolite (THC) | Biochemical verification of recent cannabis use in urine samples. A cannabis metabolite (THC) will be measured in urine samples. The metabolite can be detected up to 28 days after heavy use. The dipstick testing will have ≥50 ng/mL as a cutoff value. | 3-month postpartum |
| Number of Days in the Past 7-day Alcohol Use | The number of days in the past 7 days that participants used alcohol. | 3-month postpartum |
| Number of Days in the Past 7-day Tobacco Use | The number of days in the past 7 days that participants used tobacco. | 3-month postpartum |
| Number of Days in the Past 7-day Cannabis Use | The number of days in the past 7 days that participants used cannabis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days in the Past 7-day Cannabis Use While Breastfeeding | The number of days in the past 7 days that participants used cannabis while breastfeeding. | 3-month postpartum |
| Number of Days in the Past 7-day Tobacco Use While Breastfeeding |
| Measure | Description | Time Frame |
|---|---|---|
| Birth Weight (g) | birth weight of infants among participants who entered the study during pregnancy | at birth |
| Birth Length (cm) | birth length of infants among participants who entered the study during pregnancy |
Inclusion Criteria:
For key informant interviews in R61 To be eligible, women must (1) 18 or older, (2) be pregnant or breastfeeding with less than 12 months postpartum, (3) report alcohol use , (4) report tobacco or cannabis use
For testing in R61,
Exclusion Criteria:
- (1) women who report serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month. These women will be provided necessary referrals.
(2) Women who participated in interviews.
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| Name | Affiliation | Role |
|---|---|---|
| Yukiko Washio, PhD | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African Medical Research Council | Cape Town | South Africa |
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 | Contingent Incentives + Text-based Support | Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Contingent Incentives + Text-based Support | Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components Intervention with contingent incentives and text-based support: Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG) | An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking. The dipstick testing will have ≥300 ng/mL as a cutoff value. | Posted | Count of Participants | Participants | 3-month postpartum |
|
|
Approximately 6 months
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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 | Intervention | Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infant death | Investigations | Non-systematic Assessment | Unknown cause |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yukiko Washio, PhD | RTIInternational | 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_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 11, 2024 | Nov 21, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 3-month postpartum |
The number of days in the past 7 days that participants used tobacco while breastfeeding.
| 3-month postpartum |
| Number of Days in the Past 7-day Alcohol Use While Breastfeeding | The number of days in the past 7 days that participants used alcohol while breastfeeding. | 3-month postpartum |
| at birth |
| Gestational Age (Weeks) | Gestational age of infants among participants who entered the study during pregnancy | at birth |
| Head Circumference (cm) | Head circumference of infants among participants who entered the study during pregnancy | at birth |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Negative Urinalysis for Nicotine Metabolite (Cotinine) | Biochemical verification of recent tobacco use in urine samples. A tobacco metabolite (cotinine) will be measured in urine samples. The metabolite can be detected up to 3-4 days after use. The dipstick testing will have ≥200 ng/mL as a cutoff value. | Posted | Count of Participants | Participants | 3-month postpartum |
|
|
|
| Primary | Number of Participants With Negative Urinalysis for Cannabis Metabolite (THC) | Biochemical verification of recent cannabis use in urine samples. A cannabis metabolite (THC) will be measured in urine samples. The metabolite can be detected up to 28 days after heavy use. The dipstick testing will have ≥50 ng/mL as a cutoff value. | Posted | Count of Participants | Participants | 3-month postpartum |
|
|
|
| Primary | Number of Days in the Past 7-day Alcohol Use | The number of days in the past 7 days that participants used alcohol. | Posted | Mean | Standard Deviation | Days in the past week alcohol use | 3-month postpartum |
|
|
|
| Primary | Number of Days in the Past 7-day Tobacco Use | The number of days in the past 7 days that participants used tobacco. | Posted | Mean | Standard Deviation | Days in the past week tobacco use | 3-month postpartum |
|
|
|
| Primary | Number of Days in the Past 7-day Cannabis Use | The number of days in the past 7 days that participants used cannabis. | Posted | Mean | Standard Deviation | Days in the past week cannabis use | 3-month postpartum |
|
|
|
| Secondary | Number of Days in the Past 7-day Cannabis Use While Breastfeeding | The number of days in the past 7 days that participants used cannabis while breastfeeding. | Posted | Mean | Standard Deviation | Days in the past week BF/Cannabis | 3-month postpartum |
|
|
|
| Secondary | Number of Days in the Past 7-day Tobacco Use While Breastfeeding | The number of days in the past 7 days that participants used tobacco while breastfeeding. | Posted | Mean | Standard Deviation | Days in the past week BF/Smoking | 3-month postpartum |
|
|
|
| Secondary | Number of Days in the Past 7-day Alcohol Use While Breastfeeding | The number of days in the past 7 days that participants used alcohol while breastfeeding. | Posted | Mean | Standard Deviation | Days in the past week BF/Drinking | 3-month postpartum |
|
|
|
| Other Pre-specified | Birth Weight (g) | birth weight of infants among participants who entered the study during pregnancy | Posted | Mean | Standard Deviation | grams | at birth |
|
|
|
| Other Pre-specified | Birth Length (cm) | birth length of infants among participants who entered the study during pregnancy | Posted | Mean | Standard Deviation | cm | at birth |
|
|
|
| Other Pre-specified | Gestational Age (Weeks) | Gestational age of infants among participants who entered the study during pregnancy | Posted | Mean | Standard Deviation | weeks | at birth |
|
|
|
| Other Pre-specified | Head Circumference (cm) | Head circumference of infants among participants who entered the study during pregnancy | Posted | Mean | Standard Deviation | cm | at birth |
|
|
|
| 0 |
| 48 |
| 2 |
| 48 |
| 2 |
| 48 |
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Preterm labor | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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