Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
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|ClinicalTrials.gov Identifier: NCT03826342|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sexually Transmitted Infection Alcohol Use Complicating the Puerperium Alcohol Use Complicating Pregnancy, Unspecified Trimester Drug Use||Behavioral: Health Check-up for Expectant Moms Behavioral: Information-matched control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy|
|Actual Study Start Date :||April 16, 2019|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
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: Information-matched control
Behavioral: Information-matched control
We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.
- Number of unprotected sexual occasions (USOs) [ Time Frame: 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.
- Number of days of alcohol use measured by Timeline Follow-Back (TLFB) [ Time Frame: 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) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826342
|Contact: Kristina Countrymanemail@example.com|
|United States, Michigan|
|West Ann Arbor Health Center||Recruiting|
|Ann Arbor, Michigan, United States, 48104|
|Principal Investigator:||Golfo Tzilos Wernette||University of Michigan|