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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

The index patient must be 16-25 years

The partner must be 16-30 years

Must not have

Index participants and partners who are unable to communicate with staff or participate in study procedures due to cognitive, mental, or language difficulties will not be eligible for recruitment into the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 between 16 and 25 years old.

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My partner is between 16 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can communicate clearly and participate in all study procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner

Secondary study objectives

Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview

Awards & 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: 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

0 / 3Eligibility criteria met