N/A
N=176
Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
Sexually Transmitted Infection · Alcohol Use Complicating the Puerperium · Alcohol Use Complicating Pregnancy, Unspecified Trimester · Drug Use
Bottom Line
View on ClinicalTrials.gov: NCT03826342 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Unprotected Sexual Occasions (USOs) — 27.73; 41.50; 8.68; 14.70 USOs per participant — p=0.2964
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Health Check-up for Expectant Moms (Behavioral); Time, attention, and information-matched control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unprotected Sexual Occasions (USOs) |
27.73; 41.50; 8.68; 14.70; 11.02; 19.78 | 0.2964 |
| PRIMARY Alcohol Use Measured by Timeline Follow-Back (TLFB) |
61; 55; 7; 5; 7; 2 | 0.7915 |
| PRIMARY Cannabis Use Measured by Timeline Follow-Back (TLFB) |
25; 37; 7; 12; 6; 3 | 0.8357 |
| SECONDARY Sexually Transmitted Infections (STIs) |
3; 5; 1; 3 | 0.7496 |
| SECONDARY Unprotected Sexual Occasions (USOs) Postpartum |
2.24; 2.14 | 0.4492 |
| SECONDARY Birth Weight of Baby |
3412.31; 3244.86 | 0.0765 |
| SECONDARY Baby Head Circumference |
34.41; 34.20 | 0.535 |
| SECONDARY Baby Birth Length |
50.38; 49.94 | 0.4302 |
| SECONDARY Heavy Episodic Drinking |
14; 14; 2; 3 | 0.8070 |
| SECONDARY Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM) |
3558; 3380 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03826342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.