Couples-Based Intervention for STD Prevention

Recruiting at 1 trial location

Overseen By Steven Huettner, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: HIV, Incarceration, IPV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

68 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot project will evaluate the feasibility, acceptability, and preliminary effectiveness of a couples-based behavioral intervention \[COUPLES\] that augments individual evidence-based interventions with joint health education counseling for STI-affected AYA dyads within a primary care setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment COUPLES for STD prevention?

Research shows that couples-focused interventions can reduce unprotected sex and increase condom use, which helps prevent HIV and other sexually transmitted infections. These interventions have been tested in various populations and settings, demonstrating their potential to effectively reduce sexual risk behaviors. ^{1 2 3 4 5}

Is the Couples-Based Intervention for STD Prevention safe for humans?

The research on couple-based interventions for HIV and STD prevention does not specifically mention safety concerns, suggesting that these interventions are generally considered safe for human participants. ^{1 2 6 7 8}

How is the Couples-Based Intervention for STD Prevention different from other treatments?

The Couples-Based Intervention for STD Prevention is unique because it involves both partners in the prevention process, focusing on improving communication and mutual support to reduce risky behaviors, unlike traditional individual-focused interventions. ^{1 2 3 5 6}

Research Team

Maria E Trent, MD, MPH

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I am willing to do a phone interview in 6-8 weeks.

I have heterosexual intercourse with the patient.

Permanently reside in the greater Baltimore Metropolitan Area

Exclusion Criteria

I can communicate clearly and participate in all study procedures.

Individuals who screen positive for IPV will be referred to local resources for assistance

My partner and I are not in a same-sex relationship, not in other studies, both HIV-negative, not facing jail time soon, have less than a 5-year age gap with both of us over 16, and have no violence in our relationship.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individual evidence-based STI/HIV prevention interventions and dyadic counseling

6-8 weeks

Multiple visits for intervention sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• COUPLES
• Individual evidence-based STI/HIV prevention intervention

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of discordant reports of sexual and HIV/sexually transmitted infection risk behaviors among heterosexual couples. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Couple-based HIV prevention in the United States: advantages, gaps, and future directions. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of an HIV/STI sexual risk reduction intervention for heterosexual couples. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of single-session behavioral interventions to prevent sexually transmitted infections: implications for bundling prevention packages. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Couples-focused behavioral interventions for prevention of HIV: systematic review of the state of evidence. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Are couple-based interventions more effective than interventions delivered to individuals in promoting HIV protective behaviors? A meta-analysis. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Recruitment of minority women and their main sexual partners in an HIV/STI prevention trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Couple-based HIV prevention for low-income drug users from New York City: a randomized controlled trial to reduce dual risks. [2021]