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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
180
A brief intervention (one session plus two booster sessions)
We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.
West Ann Arbor Health Center
Ann Arbor, Michigan, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
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.
Time frame: 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.
Time frame: 6 weeks postpartum (up to 11 months)
Birth Weight of Baby
Birth weight of participants' babies was measured in grams.
Time frame: 6 weeks postpartum (up to 11 months)
Baby Head Circumference
Head circumference of participants' babies was measured in centimeters.
Time frame: 6 weeks postpartum (up to 11 months)
Baby Birth Length
Birth length of participants' babies was measured in centimeters.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks post-partum (up to 11 months)
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