Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 3:13 PM
Study NCT ID:
NCT03275168
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Developing a Dyadic Intervention for STI/HIV Prevention in Youth
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21HD090498-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |