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临床试验/NCT03368456
NCT03368456已完成不适用

Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention

University of Michigan2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年5月1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
100
试验地点
2
主要终点
Change in Adolescent HIV Testing

研究概览

简要总结

The study evaluates the preliminary efficacy of an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) to improve human immunodeficiency virus and sexually transmitted infection testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan. A Stage I randomized control trial will be conducted to examine the preliminary efficacy of S4E, relative to Usual Care (UC), over a period of six months.

详细描述

HIV/STI and drug abuse remain significant public health priorities in the US and youth are disproportionately affected. Youth between the ages of 15 - 24 constitute 25% of the sexually experienced population, yet account for 46% and 50% of HIV infections and new STIs, respectively. National surveillance data indicate that youth disproportionately engage in HIV/STI risk behaviors, including condomless sex and licit and illicit drug use, which increase their risk for HIV/STI infection. Despite the disproportionately high rates of HIV/STI infection and risk behaviors in youth, fewer than 14% report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. In Southeast Michigan, HIV/STI are disproportionately high. To address these significant public health concerns, a mobile-health (mHealth) intervention was developed for health clinic settings. The proposed research aims to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both IOS and Android operating systems, and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic. The proposed research will also evaluate the preliminary efficacy of S4E to improve HIV/STI testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan by conducting a Stage I RCT to examine the preliminary efficacy of S4E, relative to Usual Care, among a sample of 100 at-risk youth over six months.

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
None

入排标准

年龄范围
14 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Female or male youth 14-21 years of age
  • Sexually active
  • Live in Southeast Michigan
  • Have access to a smartphone or tablet
  • Youth must see an enrolled clinician to participate in the study.

排除标准

  • Report of prior psychiatric hospitalization by adolescent
  • Visible cognitive impairment due to drug use
  • Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study

结局指标

主要结局

Change in Adolescent HIV Testing

时间窗: baseline, 3 and 6 month post-baseline

Post-intervention, we will assess whether youths requested to receive HIV testing at the clinic, and at 3 and 6 months post-baseline (yes/no).

次要结局

  • Change in drug use behaviors(baseline, 3 and 6 month post-baseline)
  • Change in condomless sex behaviors(3 and 6 month post-baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Cordova

Assistant Professor

University of Michigan

研究点 (2)

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