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

Not Applicable

Active, not recruiting

Conditions: Exposure to Sexually Transmissible Disorder (Event)

Interventions: Behavioral: Intervention
Behavioral: Individual evidence-based STI/HIV prevention intervention

Registration Number: NCT03275168

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 68

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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
Control	Individual evidence-based STI/HIV prevention 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

Primary Outcome Measures

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

Name	Time	Method
Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview	6-8 weeks	Retention for the 6-8 week interview will also be calculated as a measure of acceptability.