Choices4Health: Intervention to Prevent Substance-exposed Pregnancy

NCT03633149 | Completed DMC

• 1 other identifier: R01AA022924
• Study Type: interventional
• Actual enrollment (reported): 219
• Locations: 1 country
• Sites: 1
• Actual (reported): Study Start
• Actual (reported): Primary Completion
• Actual (reported): Study Completion

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.

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

Outcome Measures

Primary Outcomes (6)

• 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.

  Risk of AEP is defined as any risk drinking (\>3 drinks/day or \>7 drinks/week on average) and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported daily alcohol use (in standard drinks), vaginal intercourse, and contraception (effective use) data from the Timeline Followback will be used to calculate risk of AEP for the previous 90 days. Change in Risk of AEP will be examined at 3-, 6-, and 9-months post-intake. A participant will be considered at risk of AEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and had more than 3 standard drinks on any day or more than 7 standard drinks per week on average in any 30 day period in the previous 90 days. Risk of AEP will be a dichotomous outcome (at risk of AEP or at reduced risk of AEP).

  3, 6, and 9 months

• 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.

  Risk of TEP is defined as currently smoking cigarettes (at least weekly use) and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported data from the Timeline Followback will be used to calculate risk of TEP for the previous 90 days at 3-, 6 , and 9 months post-intake. A participant will be considered at risk of TEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and she had at least weekly smoking in any 30 day period in the previous 90 days. Risk of TEP will be a dichotomous outcome (at risk of TEP or at reduced risk of TEP).

  3, 6, and 9 months

• 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.

  Risk of MEP is defined as any day with marijuana use and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported data from the Timeline Followback will be used to calculate risk of MEP for the previous 90 days at 3-, 6- , and 9 months post-intake. A participant will be considered at risk of MEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and had any day with marijuana use in any 30 day period in the previous 90 days. Risk of MEP will be a dichotomous outcome (at risk of MEP or at reduced risk of MEP).

  3, 6, and 9 months

• Change in risk drinking as measured by self-reported number of standard drinks on the Timeline Followback calendar.

  Risk drinking is defined as drinking more than 3 standard drinks on any day or drinking more than 7 standard drinks in a week on average in the previous 90 days. Self-reported data from the Timeline Followback will be used to calculate risk drinking for the previous 90 days at 3-, 6-, and 9-months post-intake. Risk drinking will be a dichotomous outcome (yes or no).

  3, 6, and 9 months

• Change in cigarette smoking as measured by self-reported number of cigarettes smoked each day on the Timeline Followback calendar.

  Cigarette smoking is defined as at least weekly cigarette smoking in the previous 90 days on the Timeline Followback calendar at 3-, 6-, and 9-months post-intake. Cigarette smoking will be a dichotomous outcome (yes or no). In addition, smoking will be validated using biological test to assess cotinine levels.

  3, 6, and 9 months

• Change in marijuana use as measured by self-reported use for each day on the Timeline Followback calendar.

  Marijuana use is defined as any day with any marijuana use in the previous 90 days on the Timeline Followback calendar at 3-, 6-, and 9-months post-intake. Marijuana use will be a dichotomous outcome (yes or no). In addition, marijuana use will be validated using a biological test to assess Tetrahydrocannabinol (THC) levels.

  3, 6, and 9 months

Study Arms (3)

Computer tablet-delivered C4H

EXPERIMENTAL

Two session CHOICES4Health intervention delivered by a computer tablet to address no use or ineffective use of contraception, and risky alcohol use, or cigarette smoking, or marijuana use.

Behavioral: Computer tablet-delivered C4H

Person-delivered C4H

EXPERIMENTAL

Two session CHOICES4Health intervention delivered by a counselor to address no use or ineffective use of contraception, and risky alcohol use, or cigarette smoking, or marijuana use.

Behavioral: Person-delivered C4H

Brief Advice

ACTIVE COMPARATOR

Women will receive advice and educational material from a research assistant about risk drinking, smoking, marijuana, and contraception, depending on their specific risk behaviors, as well as information about women's health. In addition, the women will receive referrals to the Harris Health System's SBIRT clinic if needed.

Behavioral: Brief Advice

Interventions

Computer tablet-delivered C4H BEHAVIORAL

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.

Also known as: C4H-T

Computer tablet-delivered C4H

Person-delivered C4H BEHAVIORAL

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.

Also known as: C4H-C

Person-delivered C4H

Brief Advice BEHAVIORAL

Brief advice delivered by a research associate about healthy behaviors for women including use of contraception and alcohol, tobacco, and marijuana use

Also known as: BA

Brief Advice

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Baylor College of Medicine: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• University of Houston: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78713, United States

Location

Related Links

• Health Behavior Research and Training Institute, University of Texas at Austin

MeSH Terms

Conditions

Marijuana Abuse; Smoking Cessation

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mary M Velasquez, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Enrollment

219 participants — actual enrollment reported by the registry.

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: August 16, 2018
• Last Updated: June 2, 2022

Study Start

June 28, 2018

Actual (reported)

Primary Completion

November 18, 2020

Actual (reported)

Study Completion

December 31, 2020

Actual (reported)

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)