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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03826342
Other study ID # HUM00143896
Secondary ID 1R01HD093611-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 16, 2019
Est. completion date July 2024

Study information

Verified date April 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250
Est. completion date July 2024
Est. primary completion date March 8, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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. Exclusion Criteria: - Unable to understand English

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Health Check-up for Expectant Moms
A brief intervention (one session plus two booster sessions)
Time, attention, and information-matched control
We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.

Locations

Country Name City State
United States West Ann Arbor Health Center Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unprotected sexual occasions (USOs) 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. Up to 6 months
Primary Number of days of alcohol use measured by Timeline Follow-Back (TLFB) Number of days of alcohol use will be measured by the TLFB by using the variable of percent days abstinent. Up to 6 months
Primary Number of days of illicit drug use measured by Timeline Follow-Back (TLFB) Illicit drug use will also be collected from the TLFB, and measured by using the "yes/no" variable for each day. Up to 6 months
Secondary Number of Sexually Transmitted Infections (STIs) Measured using urine samples or home vaginal swabs testing kits Up to 6 weeks postpartum
Secondary Number of unprotected sexual occasions (USOs) 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. Up to 6 weeks postpartum
Secondary Birth weight of baby Up to 6 weeks postpartum
Secondary Baby head circumference Up to 6 weeks postpartum
Secondary Baby birth length Up to 6 weeks postpartum
Secondary Heavy episodic drinking days Heavy drinking is defined by 4 or more drinks in a row and is measured using the TLFB Up to 6 weeks postpartum
Secondary Cost-effectiveness of Health Check-up for Expectant Moms (HCEM) 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. Up to 6 weeks post-partum
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