Clinical trial NCT03275168: Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth
Official title: Developing a Dyadic Intervention for STI/HIV Prevention in Youth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Exposure to Sexually Transmissible Disorder (Event)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-09-07
Enrollment: 68
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* 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.

Primary outcomes:
measure: Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner
timeFrame: 24 months
Secondary outcomes:
measure: Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Maria E Trent, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trent M, Yusuf HE, Rowell J, Toppins J, Woods C, Huettner S, Robinson C, Fields EL, Marcell AV, DiClemente R, Matson P. Dyadic Intervention for Sexually Transmitted Infection Prevention in Urban Adolescents and Young Adults (The SEXPERIENCE Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 25;11(5):e29389. doi: 10.2196/29389.