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临床试验/NCT03938077
NCT03938077撤回不适用

A Community-University Approach to Preventing HIV

University of Michigan4 个研究点 分布在 1 个国家开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
HIV Self-Testing

研究概览

简要总结

Examine the feasibility and acceptability of delivering the S4E intervention to 20 African-American youths between the ages 16-21 in Flint, Michigan. The investigators will examine the preliminary efficacy of the S4E intervention in improving the uptake of HIV self-testing immediately post-intervention.

详细描述

HIV is a significant public health concern in the US, and African American youth (defined as the adolescent and young adults 16-21 years of age) are disproportionately affected. Furthermore, HIV risk behaviors, including substance use and sexual risk behaviors are prominent. Despite the disproportionately high rates of HIV infection and risk behaviors in youth, few youth report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. To address these significant public health concerns, a mobile-health (mHealth) intervention, Storytelling 4 Empowerment (S4E) was developed for health clinic settings. S4E has demonstrated high feasibility, acceptability, and preliminary efficacy among youth in clinic settings. The proposed research will determine the feasibility and acceptability of delivering S4E via near peers, as well as determine the preliminary efficacy of S4E to improve HIV self-testing immediately post-intervention in a community sample (n=20) of at-risk youth ages 16-21 living in Flint, Michigan by conducting a phase I, one-arm pilot study to examine the feasibility and preliminary efficacy of S4E in improving the uptake of HIV self-testing immediately post-intervention. A University-Community approach was taken to employ principles of Community Based Participatory Research (CBPR) to determine the accessibility and acceptability of S4E when delivered by Near Peers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • 16-21 years of age
  • Sexually Active
  • African American
  • Live in Flint Michigan

排除标准

  • Report of prior psychiatric hospitalization by adolescent
  • Visible cognitive impairment due to drug use

结局指标

主要结局

HIV Self-Testing

时间窗: Immediately post-intervention

Immediately post-intervention, we will assess the binary outcome of HIV self-testing using items adopted from Lightfoot and colleagues (2018).

Lifetime HIV Testing

时间窗: Baseline

At baseline we will assess binary outcome of participant's lifetime HIV testing and collect date of most recent HIV test using an item adapted from the Centers for Disease Control (CDC) Youth Behavior Risk Survey (YRBS). A sample question for youth is "Have you every been tested for HIV?". Responses consist of "1=Yes", "0=No", and "98=Refuse to Answer".

HIV Self-Test Results Disclosure

时间窗: Immediately post-intervention

Post-intervention we will asses the percentage of youth that disclose their HIV self-test results to the Near Peer.

次要结局

  • Change in Sexual Risk Beliefs from baseline to immediately post-intervention(baseline and immediatly post-intervention)
  • Change in Future intentions regarding sexual risk from baseline to immediately post-intervention(baseline and immediatly post-intervention)
  • Change in Sexual Risk Attitudes from baseline to immediately post-intervention(baseline and immediatly post-intervention)
  • Near Peer Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ)(immediately-post intervention)
  • Eligibility rates for the Near Peer(enrollment period pre-intervention)
  • Eligibility rates for the Youth(enrollment period pre-intervention)
  • Acceptability of S4E Session for Near Peer: Session Evaluation Form (SEF)(immediately-post intervention)
  • Youth Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ(immediately-post intervention)
  • Linkage to Care and Prevention(immediately post-intervention)
  • Percent of Enrollment for Near Peer(enrollment period pre-intervention)
  • Percent of Enrollment for Youth(enrollment period pre-intervention)
  • Intervention Completion Rates for Youth(immediately post-intervention)
  • Intervention Completion Rates for Near Peer(immediately-post intervention)
  • Acceptability of S4E Session for Youth: Session Evaluation Form (SEF)(immediately-post intervention)

研究者

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

David Cordova

Associate Professor

University of Michigan

研究点 (4)

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