Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Health Check-up for Expectant Moms Theory-driven and derived from empirical support |
Behavioral: Health Check-up for Expectant Moms
A brief intervention (one session plus two booster sessions)
|
| Active Comparator: Time, attention, and information-matched control Well-validated |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Number of unprotected sexual occasions (USOs) [Baseline]
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, as well as the 8-week follow-up assessments.
Secondary Outcome Measures
- Number of days of alcohol use measured by Timeline Follow-Back (TLFB) [8 week follow-up]
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) [8 week follow-up]
Illicit drug use will also be collected from the TLFB, and measured by using the "yes/no" variable for each day.
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least one unprotected vaginal (or anal) sex occasion in the past 30 days
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Having more than one male sex partner in the last 6 months and/or having uncertainty about current partner's monogamy.
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Pregnant
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Current or past patient of Michigan Medicine
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Current alcohol/drug use risk.
Exclusion Criteria:
- Unable to understand English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West Ann Arbor Health Center | Ann Arbor | Michigan | United States | 48104 |
Sponsors and Collaborators
- University of Michigan
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Golfo Tzilos Wernette, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00143896
- 1R01HD093611-01A1