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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
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Golfo Tzilos, University of Michigan

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
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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: Information-matched control
Well-validated
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least one unprotected vaginal (or anal) sex occasion in the past 30 days
  • Pregnant
  • Plan to deliver their baby at Michigan Medicine
  • Current alcohol/drug use risk.

Exclusion Criteria:

  • Unable to understand English

Information from the National Library of Medicine

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


Contacts
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Contact: Kristina Countryman 734-998-7124 kcountry@med.umich.edu

Locations
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United States, Michigan
West Ann Arbor Health Center Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Countryman         
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Golfo Tzilos Wernette University of Michigan

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Responsible Party: Golfo Tzilos, Assistant Professor of Family Medicine and Assistant Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT03826342     History of Changes
Other Study ID Numbers: HUM00143896
1R01HD093611-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study team does not currently have a plan to share data. However, the team is currently in discussion about sharing data and will update the registration as needed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Alcohol Drinking
Sexually Transmitted Diseases
Pregnancy Complications
Drinking Behavior
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female