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临床试验/NCT03185975
NCT03185975已完成不适用

Providing Online Counseling for Home-Based HIV Testing With Transgender Youth

University of Michigan2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Increase uptake of HIV testing for transgender youth

研究概览

简要总结

This research study will recruit 200 transgender youths between the ages of 15-24. There are two arms to the research study: the control and the intervention arm. Each eligible participant will be randomized into either arm. The control arm participants receive an OraQuick HIV testing kit sent to an address of their choice and instructions of how to conduct the test. They will enter their results on the research study website and complete surveys at 3 month intervals until an entire year has passed. Participants in the intervention arm will receive an OraQuick HIV testing kit sent to them and will receive video-based counseling called Motivational Interviewing and Certified Testing and Referral. After this counseling session, the results from the OraQuick HIV test will be logged by study staff. Then, participants in the intervention arm will fill out surveys at 3 month intervals until a year has passed.

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
Single (Participant)

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • male sex at birth, identifies as female, trans feminine, trans woman, female
  • female sex at birth, identifies as male, trans male, trans masculine, male
  • agender, genderfluid, genderqueer
  • between the ages of 15-24,
  • negative or unknown HIV status and not having tested in the least 3 months
  • willingness to have HIV test kit delivered to an address they provide
  • wilingness to be tested for HIV
  • willingness to be randomized to either study arm
  • willingness and ability to participate in video-based counseling (must have a computer or tablet with video and audio capabilities, internet access)

排除标准

  • same sex assigned at birth and currently identifies as that same sex
  • aged 14 years or younger, or 25 years or older
  • reports having a positive HIV status during the baseline survey or screener survey before testing unwillingness to have HIV test kit delivered to an address they provide
  • unwillingness to test for HIV
  • unwillingness to be randomized
  • unwillingness or inability to participate in video-based counseling

研究组 & 干预措施

Control arm

Placebo Comparator

Each participant will receive an at-home test kit and will be asked to test and return results to investigator.

干预措施: at-home test kit (Behavioral)

Intervention Arm

Active Comparator

Each participant will receive an at-home test kit and will be asked to take the test in conjunction with an online Motivational interviewing/certified testing and referral (MI/CTR).

干预措施: Motivational Interviewing and Certified Testing and Referral (Behavioral)

结局指标

主要结局

Increase uptake of HIV testing for transgender youth

时间窗: 1 year

Assess differences and changes in TY's sexual-risk behaviors between those who receive the home-testing with video-based MI/CTR (intervention arm) compared to those who receive the home-testing alone (control arm). 200 TY (100 male: 100 female) will be randomized to either the intervention or control arm and followed for 6 months with surveys taken at baselines and months 3, 6, 9 and 12 months.

次要结局

  • Changes in Sexual Behavior(1 year.)
  • Linkage to Care(1 year)

研究者

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

Robert Stephenson

Professor

University of Michigan

研究点 (2)

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