Clinical trial NCT05747599: Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Official title: Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Behavior
Alcohol Drinking
Fetal Conditions
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
First posted: 2023-02-28
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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,

1. be in the second trimester of pregnancy or breastfeeding with less than 3 months postpartum,
2. test positive in alcohol use by urinalysis (i.e., EtG),
3. test positive in tobacco or cannabis use by urinalysis (i.e., cotinine and THC),
4. be over 18 years old
5. have a negative HIV test,
6. not be eligible for PrEP
7. plan to complete antenatal care at the current clinic and remain in the area for at least 3 months
8. own a cell phone to receive text messages.

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.

Primary outcomes:
measure: Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG)
timeFrame: 3-month postpartum
measure: Number of Participants With Negative Urinalysis for Nicotine Metabolite (Cotinine)
timeFrame: 3-month postpartum
measure: Number of Participants With Negative Urinalysis for Cannabis Metabolite (THC)
timeFrame: 3-month postpartum
measure: Number of Days in the Past 7-day Alcohol Use
timeFrame: 3-month postpartum
measure: Number of Days in the Past 7-day Tobacco Use
timeFrame: 3-month postpartum
measure: Number of Days in the Past 7-day Cannabis Use
timeFrame: 3-month postpartum
Secondary outcomes:
measure: Number of Days in the Past 7-day Cannabis Use While Breastfeeding
timeFrame: 3-month postpartum
measure: Number of Days in the Past 7-day Tobacco Use While Breastfeeding
timeFrame: 3-month postpartum
measure: Number of Days in the Past 7-day Alcohol Use While Breastfeeding
timeFrame: 3-month postpartum
Other outcomes:
measure: Birth Weight (g)
timeFrame: at birth
measure: Birth Length (cm)
timeFrame: at birth
measure: Gestational Age (Weeks)
timeFrame: at birth
measure: Head Circumference (cm)
timeFrame: at birth
Locations:
city: Cape Town
country: South Africa
facility: South African Medical Research Council
Study officials:
affiliation: RTI International
name: Yukiko Washio, PhD
role: PRINCIPAL_INVESTIGATOR
References: