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

Exposure to Sexually Transmissible Disorder (Event) Clinical Trial

Official title:

Developing a Dyadic Intervention for STI/HIV Prevention in Youth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03275168
• Other study ID #: IRB00148707
• Secondary ID: 1R21HD090498-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exposure to Sexually Transmissible Disorder (Event)

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner	Recruitment (as a measure of feasibility) will be assessed by calculating the number of eligible patients who return with a partner to the study appointment and consent to participate in the study.	24 months
Secondary	Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview	Retention for the 6-8 week interview will also be calculated as a measure of acceptability.	6-8 weeks