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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Baby birth length

Baby head circumference

Birth weight of baby

+4 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,795 Previous Clinical Trials

6,373,686 Total Patients Enrolled

5 Trials studying Sexually Transmitted Diseases

3,657 Patients Enrolled for Sexually Transmitted Diseases

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

1,963 Previous Clinical Trials

2,674,491 Total Patients Enrolled

23 Trials studying Sexually Transmitted Diseases

85,635 Patients Enrolled for Sexually Transmitted Diseases

Golfo Tzilos WernettePrincipal InvestigatorUniversity of Michigan

Media Library

Health Check-up for Expectant Moms Clinical Trial Eligibility Overview. Trial Name: NCT03826342 — N/A

Sexually Transmitted Diseases Research Study Groups: Health Check-up for Expectant Moms, Time, attention, and information-matched control

Sexually Transmitted Diseases Clinical Trial 2023: Health Check-up for Expectant Moms Highlights & Side Effects. Trial Name: NCT03826342 — N/A

Health Check-up for Expectant Moms 2023 Treatment Timeline for Medical Study. Trial Name: NCT03826342 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count in this experiment?

"Affirmative. According to the clinicaltrials.gov website, this experiment is in need of volunteers and was first posted on April 16th 2019 with its last update occurring on October 7th 2022. 250 people are required from a single location for participation."

Answered by AI

Would participation in this experiment be available for volunteers at present?

"As per the information provided by clinicaltrials.gov, this research is presently recruiting participants; it was first declared on April 16th 2019 and last modified on October 7th 2022."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

Adapting to the Pandemic: Protocol of a Web-based Perinatal Health Study to Improve Maternal and Infant Outcomes

Tzilos Wernette, Golfo, Kristina Countryman, Okeoma Mmeje, Quyen M Ngo, and Caron Zlotnick. 2021. “Adapting to the Pandemic: Protocol of a Web-based Perinatal Health Study to Improve Maternal and Infant Outcomes”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/30367.

JMIR Research ProtocolsJournal

Adapting to the Pandemic: Protocol of a Web-based Perinatal Health Study to Improve Maternal and Infant Outcomes

clinicaltrials.govStudy

Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy

Golfo Tzilos 2019. "Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03826342.

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