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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sexually Transmitted Infection, Alcohol Use Complicating the Puerperium, Alcohol Use Complicating Pregnancy, Unspecified Trimester, Drug Use

Intervention / Treatment
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* Behavioral: Health Check-up for Expectant Moms
* Behavioral: Time, attention, and information-matched control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Check-up for Expectant Moms<br>Theory-driven and derived from empirical support | Behavioral: Health Check-up for Expectant Moms<br>* A brief intervention (one session plus two booster sessions)<br>|
| Active Comparator: Time, attention, and information-matched control<br>Well-validated | Behavioral: Time, attention, and information-matched control<br>* We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. USOs will be assessed in the 90 days prior to the baseline, as well as the 8-week follow-up assessments. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 week follow-up | 
| 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. | 8 week follow-up |