- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275168
Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth
November 6, 2023 updated by: Johns Hopkins University
Developing a Dyadic Intervention for STI/HIV Prevention in Youth
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.
Other Names:
|
Experimental: 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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview
Time Frame: 6-8 weeks
|
Retention for the 6-8 week interview will also be calculated as a measure of acceptability.
|
6-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria E Trent, MD, MPH, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2018
Primary Completion (Actual)
October 1, 2021
Study Completion (Estimated)
November 1, 2024
Study Registration Dates
First Submitted
September 5, 2017
First Submitted That Met QC Criteria
September 5, 2017
First Posted (Actual)
September 7, 2017
Study Record Updates
Last Update Posted (Estimated)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRB00148707
- 1R21HD090498-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a small pilot trial.
De-identified data will be presented in aggregate in professional presentations and publications.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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