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

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.

Study Overview

• Status: Completed
• Conditions: Drug Use; Sexually Transmitted Infection; Alcohol Use Complicating Pregnancy, Unspecified Trimester; Alcohol Use Complicating the Puerperium
• Intervention / Treatment: Behavioral: Health Check-up for Expectant Moms; Behavioral: Time, attention, and information-matched control

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • West Ann Arbor Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Time, attention, and information-matched control; Well-validated	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexually Transmitted Infections (STIs)	STIs were measured using urine samples or home vaginal swabs testing kits, which were collected at the baseline assessment and 6 weeks postpartum. Results reflect participants whose results came back with positive results for any STI.	Baseline to 6 weeks postpartum (up to 11 months)
Unprotected Sexual Occasions (USOs) Postpartum	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 from the period of birth up to 6 weeks postpartum.	6 weeks postpartum (up to 11 months)
Birth Weight of Baby	Birth weight of participants' babies was measured in grams.	6 weeks postpartum (up to 11 months)
Baby Head Circumference	Head circumference of participants' babies was measured in centimeters.	6 weeks postpartum (up to 11 months)
Baby Birth Length	Birth length of participants' babies was measured in centimeters.	6 weeks postpartum (up to 11 months)
Heavy Episodic Drinking	Heavy episodic drinking was defined as consumption of 4 or more standard alcoholic drinks during a single day. Participants were asked if they had engaged in any heavy episodic drinking 90 days prior to baseline assessment and from the period from birth to 6 weeks postpartum. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes.	6 weeks postpartum (up to 11 months)
Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)	Cost-effectiveness was measured in US dollars (USD) and was evaluated as the incremental cost-effectiveness ratio (ICER) that considers the difference in the mean total costs and the difference in health outcomes and events between the two arms. Results reflect the cost-effectiveness evaluation based on estimated costs per case of unprotected sexual occasion averted, alcohol or illicit drug use averted, and sexually transmitted infection (STI) event averted. To develop a plausible full range, a 25% variation of the estimated mean in each arm was used. All participants who were randomized were included in the analysis for this outcome measure.	6 weeks post-partum (up to 11 months)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Golfo Tzilos Wernette, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): July 3, 2024

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Chemically-Induced Disorders; Drinking Behavior; Alcohol Drinking; Substance-Related Disorders; Infections; Communicable Diseases; Sexually Transmitted Diseases; Pregnancy Complications
• Other Study ID Numbers: HUM00143896; 1R01HD093611-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No