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

Drug Use Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Complicating Pregnancy, Unspecified Trimester
• Alcohol Use Complicating the Puerperium
• Communicable Diseases
• Drug Use
• Infections
• Pregnancy Complications
• Sexually Transmitted Diseases
• Sexually Transmitted Infection
• Substance-Related Disorders

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