Evaluation of Rapid HIV Self-testing Among MSM in High Prevalence Cities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,665
- 试验地点
- 2
- 主要终点
- Frequency of HIV Testing by Internet-recruited MSM.
研究概览
简要总结
This study seeks to determine the public health impact of providing rapid HIV test kits to men who have sex with men (MSM) so they may test themselves at their convenience. The study will determine if men who receive the rapid HIV test kits report HIV testing at least three times per year. This study will be conducted in four consecutive parts. The first three parts are formative in nature to guide the development and implementation of Part 4 of the study. The research study will use two different types of rapid HIV tests. The OraQuick® In-Home HIV Test for oral fluid (FDA approved for home use) and Sure Check® HIV 1/2 Assay, currently FDA-approved for professional use and distributed in the U.S. as Clearview® Complete HIV-1/2 Rapid Test. An Investigational Device Exemption will be obtained from the FDA to allow the contractor to supply the Sure Check® HIV 1/2 Assay to study participants since it is not approved for home use.
详细描述
The eSTAMP project will evaluate the use and impact of providing rapid HIV tests for use to men who have sex with men (MSM) recruited via the internet. Data obtained through this study will include who will use the tests, how they were used, the utility of the tests in identifying HIV infections and promoting engagement in HIV care. This will inform policies to guide the optimal use of rapid HIV tests.
This research project will be conducted in four sequential parts to evaluate the acceptability, use and effectiveness of rapid HIV test kits among MSM in cities with high HIV prevalence. Each part will be independent and they will provide information to implement the next part of the study. At the end of each part, the data will be evaluated. The findings will guide the implementation of subsequent parts of the study.
Part 1 will evaluate the materials, packaging and instructions for conducting self-testing activities. MSM will be recruited from prior research studies or over the internet to participate in focus groups and in-depth interviews by Emory University or Northwestern University. These activities will take place in Atlanta, GA and Chicago, IL. Completed.
Part 2 will evaluate the user proficiency of participants performing the rapid HIV test on themselves while under observation using the instructional and materials developed in the previous part of the study. MSM who had participated in prior research studies and consented to future contact for involvement in additional studies were recruited by Emory University. Participants will conduct activities at Emory University in Atlanta, GA. Completed.
Part 3 will evaluate the performance of the rapid HIV tests by the proposed study population in real world settings. Participants will be recruited via the internet and directed to a research study site for further study activities. Participants will be shipped study materials (one OraQuick In-home HIV test, one SureCheck HIV 1/2 Assay and one dried blood spot (DBS) collection kit). Participants will report their rapid HIV test results online and return the DBS card for laboratory HIV testing. Completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for the Part 4 randomized controlled trial are:
- •male sex at birth
- •currently identify their sex as male
- •able to provide informed consent
- •at least 18 years of age
- •report being HIV-negative or unaware of HIV status
- •resident of United States and Puerto Rico.
- •able to read instructions and complete study survey instruments in English
- •reported anal sex with at least one man in the past 12 months
- •have a valid email address, a cell phone capable of sending and receiving text messages, and a physical shipping address to receive kits
- •never diagnosed with a bleeding disorder
- •not part of an HIV vaccine trial
- •not taking antiretroviral medication for HIV.
排除标准
- •The exclusion criteria for the Part 4 randomized controlled trial are:
- •not male sex at birth
- •do not currently identify their sex as male
- •not able to provide informed consent
- •under 18 years of age
- •report being HIV-positive
- •not a resident of United States or Puerto Rico.
- •not able to read instructions and complete study survey instruments in English
- •do not report anal sex with at least one man in the past 12 months
- •do not have a valid email address, a cell phone capable of sending and receiving text messages, or a physical shipping address to receive kits
- •ever diagnosed with a bleeding disorder
- •part of an HIV vaccine trial
- •taking antiretroviral medication for HIV.
结局指标
主要结局
Frequency of HIV Testing by Internet-recruited MSM.
时间窗: 12 months
Frequency of HIV testing \>=3 times reported by participants over a 12-month follow-up period.
次要结局
- HIV Infections Among Social Network Associates(12 months)
- Newly Identified HIV Infections(12 months)
- Linkage to HIV Testing and Care Services Following a Positive Rapid Test Result.(12 months)