Clinical trial NCT03633149: Choices4Health: Intervention to Prevent Substance-exposed Pregnancy
Official title: Tablet-based Intervention to Prevent Substance-exposed Pregnancy in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Alcohol Exposure
Prenatal Tobacco Exposure
Prenatal Marijuana Exposure
Keywords: prenatal alcohol exposure
marijuana
smoking cessation
computer-delivered intervention
contraception
behavioral intervention
motivational interviewing
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
name: The University of Texas Health Science Center, Houston
name: University of Houston
First posted: 2018-08-16
Enrollment: 219
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria: Women who:

* are 18-44 years old;
* have no condition causing infertility (e.g., tubal ligation, hysterectomy, menopause);
* are not pregnant or planning to become pregnant in the next 12 months;
* are available for the follow-up period;
* had vaginal intercourse during the previous 30 days with a fertile man and did not use effective contraception every time AND are drinking at risk levels (more than 3 drinks/day or more than 7 drinks/week); OR are reporting marijuana use in the previous month, OR are currently smoking cigarettes (at least weekly use) during the 30-day baseline period.

Exclusion Criteria: Women who:

* have severe cognitive, and/or psychiatric impairment that precludes cooperation with study protocol, per judgment of the C4H interventionist or research staff;
* are unable to read, write, and speak English or Spanish;
* are unable or unwilling to meet study requirements, including followup assessments.

Primary outcomes:
measure: Change in risk of alcohol-exposed pregnancy (AEP) as measured by self-reported daily standard drinks, vaginal sex, and use of contraception on the Timeline Followback calendar.
timeFrame: 3, 6, and 9 months
measure: Change in risk of tobacco-exposed pregnancy (TEP) as measured by self-reported daily number of cigarettes, vaginal sex, and use of contraception on the Timeline Followback calendar.
timeFrame: 3, 6, and 9 months
measure: Change in risk of marijuana-exposed pregnancy (MEP) as measured by self-reported marijuana use, vaginal sex, and use of contraception on the Timeline Followback calendar.
timeFrame: 3, 6, and 9 months
measure: Change in risk drinking as measured by self-reported number of standard drinks on the Timeline Followback calendar.
timeFrame: 3, 6, and 9 months
measure: Change in cigarette smoking as measured by self-reported number of cigarettes smoked each day on the Timeline Followback calendar.
timeFrame: 3, 6, and 9 months
measure: Change in marijuana use as measured by self-reported use for each day on the Timeline Followback calendar.
timeFrame: 3, 6, and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Mary M Velasquez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: