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

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Check-up for Expectant Moms
Time, attention, and information-matched control
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • West Ann Arbor Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Health Check-up for Expectant Moms

Time, attention, and information-matched control

Arm Description

Theory-driven and derived from empirical support

Well-validated

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 30, 2019
Last Updated
September 12, 2023
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03826342
Brief Title
Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
Official Title
Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infection, Alcohol Use Complicating the Puerperium, Alcohol Use Complicating Pregnancy, Unspecified Trimester, Drug Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Check-up for Expectant Moms
Arm Type
Experimental
Arm Description
Theory-driven and derived from empirical support
Arm Title
Time, attention, and information-matched control
Arm Type
Active Comparator
Arm Description
Well-validated
Intervention Type
Behavioral
Intervention Name(s)
Health Check-up for Expectant Moms
Intervention Description
A brief intervention (one session plus two booster sessions)
Intervention Type
Behavioral
Intervention Name(s)
Time, attention, and information-matched control
Intervention Description
We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.
Primary Outcome Measure Information:
Title
Number of unprotected sexual occasions (USOs)
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Number of days of alcohol use measured by Timeline Follow-Back (TLFB)
Description
Number of days of alcohol use will be measured by the TLFB by using the variable of percent days abstinent.
Time Frame
8 week follow-up
Title
Number of days of illicit drug use measured by Timeline Follow-Back (TLFB)
Description
Illicit drug use will also be collected from the TLFB, and measured by using the "yes/no" variable for each day.
Time Frame
8 week follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golfo Tzilos Wernette
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Ann Arbor Health Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
34351867
Citation
Tzilos Wernette G, Countryman K, Mmeje O, Ngo QM, Zlotnick C. Adapting to the Pandemic: Protocol of a Web-Based Perinatal Health Study to Improve Maternal and Infant Outcomes. JMIR Res Protoc. 2021 Sep 10;10(9):e30367. doi: 10.2196/30367.
Results Reference
derived

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

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