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临床试验/NCT03275168
NCT03275168已完成不适用

Developing a Dyadic Intervention for STI/HIV Prevention in Youth

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Single blind

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview(6-8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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