Skip to main content
Clinical Trials/NCT03275168
NCT03275168
Completed
N/A

Developing a Dyadic Intervention for STI/HIV Prevention in Youth

Johns Hopkins University1 site in 1 country68 target enrollmentJanuary 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Exposure to Sexually Transmissible Disorder (Event)
Sponsor
Johns Hopkins University
Enrollment
68
Locations
1
Primary Endpoint
Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
October 1, 2021
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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.

Outcomes

Primary Outcomes

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

Time Frame: 24 months

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.

Secondary Outcomes

  • Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview(6-8 weeks)

Study Sites (1)

Loading locations...

Similar Trials