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Technology-Based Intervention for STIs and Substance Use in Pregnancy
N/A
Waitlist Available
Led By Golfo Tzilos Wernette
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether an online health check-up, which provides information and brief interventions for sexually transmitted infections and alcohol/drug use, reduces risk more than a control condition for pregnant women.
Who is the study for?
This trial is for pregnant women who currently use alcohol or drugs, have had unprotected sex recently, and may have multiple sexual partners or concerns about their partner's fidelity. Participants must understand English.
What is being tested?
The study tests a computer program called Health Check-up for Expectant Moms (HCEM) designed to reduce the risk of sexually transmitted infections and substance use during pregnancy compared to a control group receiving similar attention but different content.
What are the potential side effects?
Since this intervention involves health education rather than medication, there are no direct side effects like those associated with drugs. However, participants might experience stress or discomfort discussing sensitive topics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of days of alcohol use measured by Timeline Follow-Back (TLFB)
Number of days of illicit drug use measured by Timeline Follow-Back (TLFB)
Unprotected sexual occasions (USOs)
Secondary study objectives
Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)
Heavy episodic drinking days
Number of Sexually Transmitted Infections (STIs)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Health Check-up for Expectant MomsExperimental Treatment1 Intervention
Theory-driven and derived from empirical support
Group II: Time, attention, and information-matched controlActive Control1 Intervention
Well-validated
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,432,775 Total Patients Enrolled
6 Trials studying Sexually Transmitted Diseases
3,917 Patients Enrolled for Sexually Transmitted Diseases
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,054 Previous Clinical Trials
2,731,384 Total Patients Enrolled
24 Trials studying Sexually Transmitted Diseases
87,501 Patients Enrolled for Sexually Transmitted Diseases
Golfo Tzilos WernettePrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot understand English.I have had multiple male partners recently or am unsure if my partner is monogamous.
Research Study Groups:
This trial has the following groups:- Group 1: Health Check-up for Expectant Moms
- Group 2: Time, attention, and information-matched control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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