Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth

NCT ID: NCT03275168

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2021-10-01

Brief Summary

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.

Detailed Description

While public health programs have demonstrated modest success in reducing the adolescent and young adult (AYA) risk for STI/HIV, significant health disparities remain. The risk of STI/HIV is not uniform among AYA. AYA residing in segregated urban communities with high STI prevalence and complicated sexual networks face even greater risk for disease and associated complications. Additional supports designed to increase engagement in care and reduce STI acquisition and transmissions are urgently needed to meet the sexual health and reproductive health goals for the nation. Overwhelmingly, AYA STI prevention interventions have targeted individuals and individual-level factors. While effective, these interventions do not adequately address other important influences affecting AYA risk for STI/HIV, such as partner or relationship influences on sexual decision-making and behavior. Partner notification and treatment is a key strategy for disease control and has previously been tested among adults for STI/HIV prevention work but has yet to be evaluated for AYA. Our prior research demonstrates that AYAs with complicated STIs are likely to notify their partners to seek treatment (88-92%); however, AYAs receiving brief behavioral interventions, relative to those receiving standard of care were 3 times more likely to be successful in arranging for their partner's treatment. Thus, partner interventions may hold promise for harnessing the power of relationship dynamics to enhance sexual decision-making, communication, and subsequent health behaviors. The investigators propose to pilot test an intervention designed to change sexual health outcomes by understanding partners and the learning environment related to sex [COUPLES] by simultaneously delivering two evidence-based STI/HIV prevention interventions Sister-to-Sister Teen and Focus on the Future. The simultaneous delivery of effective interventions will be augmented with a joint partner health education counseling session focused on enhancing communication and negotiation of safe sexual practices within the relationship. If successful, this pilot will support the development of a larger trial designed to evaluate the effectiveness of this approach in the busy primary care setting by providing evidence that AYA can and will safely engage their partners in a supportive primary care setting that integrates high quality treatment with evidence-based STI/HIV prevention interventions delivered by health educator teams.

Conditions

Exposure to Sexually Transmissible Disorder (Event)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

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

Group Type: ACTIVE_COMPARATOR

Individual evidence-based STI/HIV prevention intervention

Intervention Type: BEHAVIORAL

Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.

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 Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).

Interventions

Intervention

Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).

Intervention Type: BEHAVIORAL

Individual evidence-based STI/HIV prevention intervention

Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.

Intervention Type: BEHAVIORAL

Other Intervention Names

Sister to Sister / Focus on the Future

Eligibility Criteria

Inclusion Criteria

The index patient must be

• 16-25 years
• Engage in male-female [heterosexual] intercourse
• Permanently reside in the Greater Baltimore Metropolitan Area (GBMA)
• Willing to recruit their main sexual partner for the study
• Willing to participate in a single individual session with a health educator followed by a joint debriefing session together
• Willing to be contacted in 6-8 weeks for a telephone interview

The partner must be

• 16-30 years
• Engage in male-female [heterosexual] intercourse with the index patient
• Permanently reside in the greater Baltimore Metropolitan Area
• Willing to participate in a single individual session with a health educator followed by a joint debriefing session together
• Willing to be contacted in 6-8 weeks for a telephone interview

Exclusion Criteria

• 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.
• Dyads will also be excluded if in same-sex main partnership or a member of the couple is currently enrolled in another sexual behavior study, one or both partners has a known concurrent HIV infection, one or more partners has a pending incarceration, there is more than five years age difference between the two partners and one partner is <16 years of age, or there is evidence of intimate partner violence (IPV) in the relationship.
• Individuals who screen positive for IPV will be referred to local resources for assistance.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria E Trent, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Medicine

Baltimore, Maryland, United States

Countries

United States

References

Trent M, Yusuf HE, Rowell J, Toppins J, Woods C, Huettner S, Robinson C, Fields EL, Marcell AV, DiClemente R, Matson P. Dyadic Intervention for Sexually Transmitted Infection Prevention in Urban Adolescents and Young Adults (The SEXPERIENCE Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 25;11(5):e29389. doi: 10.2196/29389.

Reference Type: DERIVED

PMID: 35612881 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21HD090498-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00148707

Identifier Type: -

Identifier Source: org_study_id