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临床试验/NCT02834572
NCT02834572终止不适用

Using Technology to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options

New York Blood Center1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
236
试验地点
1
主要终点
Number of participants reporting having an HIV test as assessed by questionnaire

研究概览

简要总结

Young Black men who have sex with men (MSM) and transwomen in the US are affected by HIV at severely disproportionate rates. A key component of HIV prevention for communities at risk is diagnosing HIV infections through regular HIV testing. A significant proportion of young Black MSM and transwomen have not tested in the prior year. This research study seeks to address low HIV testing rates among young Black MSM and transwomen by testing a brief Internet-based HIV testing intervention optimized for mobile devices. The intervention takes advantage of the variety of HIV testing options now available, including the HIV self testing, couples-based HIV counseling and testing and traditional clinic-based testing and will provide men and transwomen with a tailored recommendation of their optimal HIV testing approach. The investigators are conducting a pilot randomized study among young Black MSM and transwomen followed for 6 months to estimate the intervention's potential efficacy in increasing HIV testing.

详细描述

We are conducting a pilot study among 240 young Black MSM and transgender women randomized to the Intervention Arm (assessment and algorithm to deliver a tailored recommendation) or Control (assessment and standard HIV testing information) and followed for 6 months to estimate the intervention's potential efficacy in increasing HIV testing. After informed consent, participants are asked to provide contact information on the locator form. Then, participants complete a brief quantitative assessment including basic demographics, HIV testing history and other factors related to HIV testing. All participants, regardless of study arm, then receive information about each HIV testing method including how the tests are conducted (blood, oral sample), and availability of counseling and support. Participants then are randomized into 1 of the 2 study arms. A computer program will randomly assign each participant using randomly ordered block sizes of 4 and 6 and stratified by age (16-23, 24-29 years) to balance groups.

Participants assigned to the Intervention Arm will complete a brief quantitative assessment lasting approximately 2-3 minutes to assess those factors associated with HIV testing and thus are needed to complete the algorithm. They then receive the results of the HIV testing algorithm, presented as their personalized HIV testing approach. All participants will receive information on resources in New York City to test by all of these methods. The control participants are provided with the above information about each testing approach but without a recommended approach.

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 (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • male at birth;
  • self-identify as Black, African American, Caribbean Black, African Black or multiethnic Black;
  • able to read and respond in English;
  • between 16-29 years of age;
  • known to be HIV-infected;
  • insertive or receptive anal intercourse with a man or transwoman in the last 12 months;
  • reside in the New York City metropolitan area

排除标准

  • enrolled in any other HIV research study involving HIV testing
  • participant in an HIV vaccine trial
  • currently taking pre-exposure prophylaxis

研究组 & 干预措施

All About Me

Experimental

assessment and algorithm to provide participants with a tailored recommendation of their optimal HIV testing approach

干预措施: All About Me (Behavioral)

Control

Active Comparator

HIV testing information

干预措施: Control (Behavioral)

结局指标

主要结局

Number of participants reporting having an HIV test as assessed by questionnaire

时间窗: 3 months

Self-reported HIV test in the prior 3 months assessed by questionnaire

次要结局

  • Number of participants who are aware of HIV self-testing and couples based voluntary counseling and testing as assessed by questionnaire(3 months)
  • Number of intervention participants recommended a self-test who use a self-test as assessed by questionnaire(3 months)
  • Number of intervention participants recommended testing at a clinic who test at a clinic as assessed by questionnaire(3 months)
  • Number of intervention participants recommended couples testing who test using couples testing as assessed by questionnaire(3 months)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Beryl Koblin, Ph, D.

Principal Investigator

New York Blood Center

研究点 (1)

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