Choices4Health: Intervention to Prevent Substance-exposed Pregnancy

NCT03633149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2022-06-02

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER
  • The University of Texas Health Science Center, Houston

    collaborator OTHER
  • University of Houston

    collaborator OTHER
  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Mary M Velasquez, Ph.D. · University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2020-11-18
Completion
2020-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633149 on ClinicalTrials.gov