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Couples-Based Intervention for STD Prevention

N/A
Waitlist Available
Led By Maria E Trent, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to be contacted in 6-8 weeks for a telephone interview
The index patient must be 16-25 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will test a new couples-based intervention for STI-affected young adults. The goal is to see if it is feasible, acceptable, and effective.

Who is the study for?
This trial is for young individuals aged 16-25 in the Baltimore area who have a main sexual partner willing to join the study. Both must engage in heterosexual intercourse and be available for follow-up interviews. Exclusions include cognitive impairments, same-sex partnerships, concurrent HIV or other sexual behavior studies participation, significant age gaps with minors, or intimate partner violence.Check my eligibility
What is being tested?
The trial tests a couples-based STI/HIV prevention program [COUPLES] that combines individual interventions with joint counseling sessions. It aims to assess how feasible and effective this approach is when conducted within primary care settings for affected adolescent and young adult dyads.See study design
What are the potential side effects?
Since this intervention involves education and counseling rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort or relationship strain during discussions about sensitive topics like sexual health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to do a phone interview in 6-8 weeks.
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I am between 16 and 25 years old.
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I have heterosexual intercourse with the patient.
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I am willing to attend a session with a health educator and a group debrief.
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I am willing to attend a session with a health educator and a group debrief.
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My partner is between 16 and 30 years old.
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I am willing to do a phone interview in 6-8 weeks.
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I am willing to involve my main sexual partner in the study.
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I engage in heterosexual intercourse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner
Secondary outcome measures
Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner
Group II: ControlActive Control1 Intervention
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention
2011
Completed Phase 4
~73780

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,776 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,569 Total Patients Enrolled
Maria E Trent, MD, MPHPrincipal InvestigatorJohns Hopkins University

Media Library

COUPLES Clinical Trial Eligibility Overview. Trial Name: NCT03275168 — N/A
Sexually Transmitted Disease Research Study Groups: Intervention, Control
Sexually Transmitted Disease Clinical Trial 2023: COUPLES Highlights & Side Effects. Trial Name: NCT03275168 — N/A
COUPLES 2023 Treatment Timeline for Medical Study. Trial Name: NCT03275168 — N/A

Frequently Asked Questions

~9 spots leftby Mar 2025