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 : December 6, 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: Time, attention, and 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: Time, attention, and information-matched control
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826342
|Contact: Kristina Countrymanfirstname.lastname@example.org|
|United States, Michigan|
|West Ann Arbor Health Center||Recruiting|
|Ann Arbor, Michigan, United States, 48104|
|Principal Investigator:||Golfo Tzilos Wernette||University of Michigan|