CCTG 599: Pre-exposure Prophylaxis Accessibility Research and Evaluation (PrEPARE) 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- PrEP uptake between informed vs not-informed of risk score
研究概览
简要总结
This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to determine if providing high-risk subjects with a calculated risk score changes the likelihood of pre-exposure prophylaxis (PrEP) uptake.
详细描述
All men who have sex with men (MSM) and male-to-female transgender individuals who have sex with men who present to TNC for HIV testing and are at risk for HIV will be offered enrollment in this study (see study schema). Upon enrollment, subjects will be given an Ipad-based computerized questionnaire that assesses their risk perception, demographics, risk behavior, and perception of whether they are a candidate for PrEP. Upon completion of the survey they will be randomized into 1 of 2 arms. Subjects in the intervention arm will receive the results of their risk score based on a risk calculator developed at UCSD and the Center for Disease Control and Prevention's tool for Assessing Risk for Contracting HIV (ARCH, formerly known as the HIV Incidence Risk Index for MSM, or HIRI-MSM), whereas subjects in the control arm will not receive this information. Both groups will receive standard risk reduction counseling. Subjects will be contacted by phone 2 months after enrollment to determine whether they initiated PrEP or not, to re-assess their risk perception, and to provide a link to a final online survey. If subjects have not completed the survey 4 weeks after being provided with the link, they will receive a text-message reminder.
The analysis of the data will begin 12 weeks after the last study subject is enrolled.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Man or transgender M to F who has sex with men.
- •Age 18 years or older.
- •Subjects must have substantial ongoing risk of acquisition of HIV as evident by one or more of the following: One or more episode of unprotected anal intercourse with a HIV-infected partner or a partner with unknown HIV status within the last 6 months
- •Negative for HIV infection by rapid HIV test
排除标准
- •Unable to give informed consent.
- •Signs or symptoms suggestive of acute HIV infection
- •Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
结局指标
主要结局
PrEP uptake between informed vs not-informed of risk score
时间窗: 12 Weeks
To compare the proportion of subjects that initiate PrEP between subjects who were informed of their calculated HIV risk score to that of subjects who were not informed of their calculated risk score
次要结局
未报告次要终点
研究者
Sheldon Morris
Clinical Professor
University of California, San Diego