Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
- Conditions
- Sexually Transmitted InfectionAlcohol Use Complicating the PuerperiumAlcohol Use Complicating Pregnancy, Unspecified TrimesterDrug Use
- Interventions
- Behavioral: Health Check-up for Expectant MomsBehavioral: Time, attention, and information-matched control
- Registration Number
- NCT03826342
- Lead Sponsor
- University of Michigan
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
- 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.
- Unable to understand English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health Check-up for Expectant Moms Health Check-up for Expectant Moms Theory-driven and derived from empirical support Time, attention, and information-matched control Time, attention, and information-matched control Well-validated
- Primary Outcome Measures
Name Time Method Unprotected Sexual Occasions (USOs) 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.
Alcohol Use Measured by Timeline Follow-Back (TLFB) 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.
Cannabis Use Measured by Timeline Follow-Back (TLFB) 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 Outcome Measures
Name Time Method Heavy Episodic Drinking 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.
Sexually Transmitted Infections (STIs) 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.
Unprotected Sexual Occasions (USOs) Postpartum 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.
Birth Weight of Baby 6 weeks postpartum (up to 11 months) Birth weight of participants' babies was measured in grams.
Baby Head Circumference 6 weeks postpartum (up to 11 months) Head circumference of participants' babies was measured in centimeters.
Baby Birth Length 6 weeks postpartum (up to 11 months) Birth length of participants' babies was measured in centimeters.
Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM) 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.
Trial Locations
- Locations (1)
West Ann Arbor Health Center
🇺🇸Ann Arbor, Michigan, United States