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

NCT03826342 | Completed Results DMC

• 2 other identifiers: HUM001438961R01HD093611-01A1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Unprotected Sexual Occasions (USOs)

  USOs were instances of sexual intercourse where neither partner utilized any form of contraception. Participants were assessed using Timeline Follow-Back (TLFB), a calendar assisted structured interview that provided a way to cue memory so that accurate recall was enhanced for event-level data. TLFB has been used to assess sexual risk-taking. Participants were asked to provide the number of USOs experienced 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up.

  Up to 6 months

• Alcohol Use Measured by Timeline Follow-Back (TLFB)

  Alcohol use was measured by the TLFB. Participants were asked if they had consumed any standard alcoholic drinks 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes.

  Up to 6 months

• Cannabis Use Measured by Timeline Follow-Back (TLFB)

  Cannabis use was measured by the TLFB. Participants were asked if they had used or consumed any cannabis 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes.

  Up to 6 months

Secondary Outcomes (7)

• Sexually Transmitted Infections (STIs)

  Baseline to 6 weeks postpartum (up to 11 months)

• Unprotected Sexual Occasions (USOs) Postpartum

  6 weeks postpartum (up to 11 months)

• Birth Weight of Baby

  6 weeks postpartum (up to 11 months)

• Baby Head Circumference

  6 weeks postpartum (up to 11 months)

• Baby Birth Length

  6 weeks postpartum (up to 11 months)

Study Arms (2)

Health Check-up for Expectant Moms

EXPERIMENTAL

Theory-driven and derived from empirical support

Behavioral: Health Check-up for Expectant Moms

Time, attention, and information-matched control

ACTIVE COMPARATOR

Well-validated

Behavioral: Time, attention, and information-matched control

Interventions

Health Check-up for Expectant Moms BEHAVIORAL

A brief intervention (one session plus two booster sessions)

Health Check-up for Expectant Moms

Time, attention, and information-matched control BEHAVIORAL

We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.

Time, attention, and information-matched control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to understand English

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

West Ann Arbor Health Center

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (1)

• 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.

  PMID: 34351867 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Time

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Golfo Tzilos Wernette
• Organization: University of Michigan

gtzilos@med.umich.edu

734-988-3424

Study Officials

• Golfo Tzilos Wernette

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family Medicine and Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 1, 2019
• Study Start: April 16, 2019
• Primary Completion: March 8, 2024
• Study Completion: July 3, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)