NCT03633149

Choices4Health: Intervention to Prevent Substance-exposed Pregnancy

Tablet-based Intervention to Prevent Substance-exposed Pregnancy in Primary Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

This is a 4-year randomized, controlled study to test the efficacy of the CHOICES4Health-T (C4H-T) delivered by a computerized tablet, CHOICES4Health-C (C4H-C), delivered by a counselor, and brief advice (BA), on reducing preconception substance-exposed pregnancy risk (i.e. drinking below risk levels; tobacco and marijuana cessation; effective contraception use) among women (aged 18-44) presenting to the 13 primary care clinics that serve adults within the Harris Health System. Given the natural fit between contraceptive and HIV prevention counseling the CHOICES4Health interventions will also target HIV sexual risk behaviors.

Detailed description

A randomized group design (N = 240) will be used to test the efficacy of the C4H-C and C4H-T interventions relative to Brief Advice (BA) to reduce the risk of substance-exposed pregnancy) SEP in preconception women of childbearing age. Follow-up assessments will be conducted at 3, 6, and 9 months. Each of the substances targeted in this study (risk drinking, cigarette smoking, and marijuana use) is commonly used relative to other substances and is singly or jointly associated with risk for poor fetal outcomes. Thus, women who are not using effective contraception (i.e., use of effective birth-control methods during all vaginal intercourse) and have any one or more substance-risk behaviors in the 30 days before intake will be eligible for the study. Urn randomization will be used to stratify women on all three substance-risk behaviors to ensure a balanced number of women presenting with alcohol-exposed pregnancy (AEP), tobacco-exposed pregnancy (TEP), and marijuana-exposed pregnancy (MEP) risks across the three study conditions. To address risk distribution for women who present with more than one risk behavior the urn randomization will also be programmed to balance single risk and multiple risk women across the study conditions. In sum, the urn randomization will include four assignment criteria: AEP, TEP, MEP, and multiple risks. Finally, different numbers of women will be needed for each type of substance-exposed pregnancy risk in order to provide sufficient power for the investigator's analytic tests. For example, approximately 25% more women at risk of AEP are required than for TEP to attain the same power. The investigators will include over sampling rules and stopping rules to ensure adequate recruitment for AEP, TEP, and MEP.

Conditions

• Prenatal Alcohol Exposure
• Prenatal Tobacco Exposure
• Prenatal Marijuana Exposure

Interventions

Type	Name	Description
BEHAVIORAL	Computer tablet-delivered C4H	Two session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered on a computer-tablet.
BEHAVIORAL	Person-delivered C4H	Two session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered by a counselor.
BEHAVIORAL	Brief Advice	Brief advice delivered by a research associate about healthy behaviors for women including use of contraception and alcohol, tobacco, and marijuana use

Timeline

• Start date: 2018-06-28
• Primary completion: 2020-11-18
• Completion: 2020-12-31
• First posted: 2018-08-16
• Last updated: 2022-06-02

Locations

1 site across 1 country: United States