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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 : December 6, 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

Tracking Information
First Submitted Date  ICMJE January 30, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date December 6, 2019
Actual Study Start Date  ICMJE April 16, 2019
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03826342 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
Official Title  ICMJE Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Sexually Transmitted Infection
  • Alcohol Use Complicating the Puerperium
  • Alcohol Use Complicating Pregnancy, Unspecified Trimester
  • Drug Use
Intervention  ICMJE
  • Behavioral: Health Check-up for Expectant Moms
    A brief intervention (one session plus two booster sessions)
  • 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.
Study Arms  ICMJE
  • Experimental: Health Check-up for Expectant Moms
    Theory-driven and derived from empirical support
    Intervention: Behavioral: Health Check-up for Expectant Moms
  • Active Comparator: Time, attention, and information-matched control
    Well-validated
    Intervention: Behavioral: Time, attention, and information-matched control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristina Countryman 734-998-7124 kcountry@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03826342
Other Study ID Numbers  ICMJE HUM00143896
1R01HD093611-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Golfo Tzilos, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Golfo Tzilos Wernette University of Michigan
PRS Account University of Michigan
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP