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Completed

NCT Number: NCT03826342

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West Ann Arbor Health Center

Ann Arbor, Michigan, 48104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Check-up for Expectant Moms

Behavioral

A brief intervention (one session plus two booster sessions)

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.

Primary outcomes

  1. Unprotected Sexual Occasions (USOs)

    Time frame: Up to 6 months

    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.

  2. Alcohol Use Measured by Timeline Follow-Back (TLFB)

    Time frame: Up to 6 months

    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.

  3. Cannabis Use Measured by Timeline Follow-Back (TLFB)

    Time frame: Up to 6 months

    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.

Secondary outcomes

  1. Sexually Transmitted Infections (STIs)

    Time frame: Baseline to 6 weeks postpartum (up to 11 months)

    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.

  2. Unprotected Sexual Occasions (USOs) Postpartum

    Time frame: 6 weeks postpartum (up to 11 months)

    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.

  3. Birth Weight of Baby

    Time frame: 6 weeks postpartum (up to 11 months)

    Birth weight of participants' babies was measured in grams.

  4. Baby Head Circumference

    Time frame: 6 weeks postpartum (up to 11 months)

    Head circumference of participants' babies was measured in centimeters.

  5. Baby Birth Length

    Time frame: 6 weeks postpartum (up to 11 months)

    Birth length of participants' babies was measured in centimeters.

  6. Heavy Episodic Drinking

    Time frame: 6 weeks postpartum (up to 11 months)

    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.

  7. Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)

    Time frame: 6 weeks post-partum (up to 11 months)

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2019
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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