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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03275168
Recruitment Status : Active, not recruiting
First Posted : September 7, 2017
Results First Posted : February 8, 2022
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Exposure to Sexually Transmissible Disorder (Event) Behavioral: Intervention Behavioral: Individual evidence-based STI/HIV prevention intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Single blind
Primary Purpose: Prevention
Official Title: Developing a Dyadic Intervention for STI/HIV Prevention in Youth
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : October 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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
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.
Other Name: Sister to Sister / Focus on the Future

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
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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Heterosexual dyads based on female and male biology recruited for study.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275168


Locations
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United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Maria E Trent, MD, MPH Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03275168    
Other Study ID Numbers: IRB00148707
1R21HD090498-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2017    Key Record Dates
Results First Posted: February 8, 2022
Last Update Posted: February 8, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a small pilot trial. De-identified data will be presented in aggregate in professional presentations and publications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No