Couples-Based Intervention for STD Prevention

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a couples-based health education program to prevent sexually transmitted infections (STIs). It combines individual and joint counseling for young couples, focusing on improving communication and negotiation skills to reduce STI risk. Participants will receive either this new combined intervention, called COUPLES, or the individual evidence-based STI/HIV prevention intervention. Couples living in the Greater Baltimore area who engage in heterosexual intercourse and are willing to participate in sessions together may be a good fit for this trial. As an unphased trial, the study offers participants the opportunity to contribute to innovative prevention strategies that could benefit many others in the future.

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 prior data suggests that this couples-based intervention is safe for STD prevention?

Research has shown that couple-based programs for preventing HIV and STDs are generally safe and well-received. These programs often lead to positive outcomes, such as increased condom use and reduced infection rates.

While the specific COUPLES program in this trial differs slightly, similar programs have been successfully implemented in various locations. Studies have not reported any major safety issues. Participants often find these programs beneficial because they address both personal and relationship aspects.

Although this trial does not test a new drug or medical procedure, the behavioral program relies on methods previously used without major problems. This suggests the program is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a couples-based approach to preventing STDs, which is different from the usual individual-focused strategies. Most treatments for preventing STIs and HIV focus on individual education and behavioral interventions. However, this trial adds a unique element by including dyadic counseling and negotiation practice with partners, which could enhance communication and cooperation within relationships. This innovative approach could potentially lead to better prevention outcomes by engaging both partners in the process, rather than just focusing on individuals separately.

What evidence suggests that this trial's treatments could be effective for STD prevention?

This trial will compare a couples-based intervention with an individual intervention for STD prevention. Studies have shown that couple-based programs can help reduce risky sexual behaviors, such as having sex without a condom. These programs involve both partners learning about health together, leading to better communication and safer habits. Research indicates that when couples participate together, they may be more likely to take preventive actions. Initial findings suggest these programs can effectively improve young people's overall sexual health. Involving both partners in prevention efforts appears to make a positive difference. ^{6 7 8 9 10}

Who Is on the Research Team?

Maria E Trent, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Permanently reside in the greater Baltimore Metropolitan Area

I have heterosexual intercourse with the patient.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2729473

Effectiveness of a Couple-Based HIV and Sexually ... This randomized clinical trial compares the effectiveness of a 5-session couple-based intervention vs a 1-session counseling, testing, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30924895/

Effectiveness of a Couple-Based HIV and Sexually ... - PubMed The PACT intervention appeared to reduce risky sexual behaviors, such as condomless intercourse; this finding suggests that a couple-based HIV and STI ...

3. sig.columbia.edu sig.columbia.edu/sites/sig.columbia.edu/files/content/PACT_elbassel_2019_oi_190066%20couples.pdf

Effectiveness of a Couple-Based HIV and Sexually Transmitted CONCLUSIONS AND RELEVANCE The PACT intervention appeared to reduce risky sexual behaviors, such as condomless intercourse; this finding suggests ...

4. ajph.aphapublications.org ajph.aphapublications.org/doi/full/10.2105/AJPH.93.6.963

The Efficacy of a Relationship-Based HIV/STD Prevention ... No significant differences in outcomes were observed between women who received the intervention together with a partner and women who received ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074822003705

Dyadic Intervention for Sexually Transmitted Infection ... Among adults, engagement of couples (or sexual dyads) for STI/HIV prevention have proven effective [20,21]. Research with AYA suggests that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1447878/

The Efficacy of a Relationship-Based HIV/STD Prevention ... No significant differences in effects were observed between couples receiving the intervention together and those in which the woman received it alone.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5870874/

Couple-Based HIV Prevention in the United States This paper presents an overview of couple-based HIV prevention research to date, advantages of using and core components of couple-based interventions, ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/225999

National Institute of Mental Health Multisite Eban HIV/STD ... Several studies found that couple-based HIV counseling and testing increased condom use and reduced HIV/STD transmission in international settings among ...

9. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10497315221118850

Couple-Based Behavioral HIV Interventions by the Social ... Results: We identified nine couple-based interventions. Outcomes included reduced sexual and substance use-related risk behaviors and improved ...

10. link.springer.com link.springer.com/article/10.1007/s10461-022-03897-x

Moderation Analysis of a couple-based HIV/STI ... We used moderation analysis from a randomized clinical trial to evaluate whether a couples-based HIV/STI intervention may have differential effectiveness.