Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy

Not Applicable

Active, not recruiting

• Conditions: Sexually Transmitted Infection; Alcohol Use Complicating the Puerperium; Alcohol Use Complicating Pregnancy, Unspecified Trimester; Drug Use
• Interventions: Behavioral: Health Check-up for Expectant Moms; Behavioral: Time, attention, and information-matched control

• Registration Number: NCT03826342
• Lead Sponsor: University of Michigan

Brief Summary

This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a computer-delivered screening and brief intervention (SBI) that simultaneously targets sexually transmitted infection (STI) risk and alcohol/drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-04-16
• Primary Completion: 2024-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• At least one unprotected vaginal (or anal) sex occasion in the past 30 days
• Having more than one male sex partner in the last 6 months and/or having uncertainty about current partner's monogamy.
• Pregnant
• Current alcohol/drug use risk.

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Exclusion Criteria

• Unable to understand English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Check-up for Expectant Moms	Health Check-up for Expectant Moms	Theory-driven and derived from empirical support
Time, attention, and information-matched control	Time, attention, and information-matched control	Well-validated

Primary Outcome Measures

Name	Time	Method
Number of days of alcohol use measured by Timeline Follow-Back (TLFB)	Up to 6 months	Number of days of alcohol use will be measured by the TLFB by using the variable of percent days abstinent.
Number of days of illicit drug use measured by Timeline Follow-Back (TLFB)	Up to 6 months	Illicit drug use will also be collected from the TLFB, and measured by using the "yes/no" variable for each day.
Unprotected sexual occasions (USOs)	Up to 6 months	Timeline Follow-Back (TLFB) is used to assess USOs which are sex-risk behaviors . The TLFB is a calendar assisted structured interview that provides a way to cue memory so that accurate recall is enhanced for event-level data; it has been used to assess sexual risk-taking. USOs will be assessed in the 90 days prior to the baseline, the 8-week follow-up assessment, and the 6 month follow up.

Secondary Outcome Measures

Name	Time	Method
Number of Sexually Transmitted Infections (STIs)	Up to 6 weeks postpartum	Measured using urine samples or home vaginal swabs testing kits
Birth weight of baby	Up to 6 weeks postpartum
Baby head circumference	Up to 6 weeks postpartum
Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)	Up to 6 weeks post-partum	The cost-effectiveness evaluation of HCEM is cost per case of unprotected sexual occasion averted, cost per case of alcohol/illicit drug use averted, and cost per STI event averted.
Number of unprotected sexual occasions (USOs)	Up to 6 weeks postpartum	Timeline Follow-Back (TLFB) is used to assess USOs which are sex-risk behaviors . The TLFB is a calendar assisted structured interview that provides a way to cue memory so that accurate recall is enhanced for event-level data; it has been used to assess sexual risk-taking.
Heavy episodic drinking days	Up to 6 weeks postpartum	Heavy drinking is defined by 4 or more drinks in a row and is measured using the TLFB
Baby birth length	Up to 6 weeks postpartum

Trial Locations

Locations (1)

West Ann Arbor Health Center; 🇺🇸 Ann Arbor, Michigan, United States