NCT02371525已完成不适用
Enhancing PrEP in Community Settings (EPIC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- PrEP adherence among young MSM over time based on dried blood spot (DBS)
研究概览
简要总结
To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM).
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 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •HIV-uninfected as determined by a negative/non-reactive laboratory test within 7 days of Enrollment (as defined in the study-specific procedures (SSP) Manual).
- •Interested in initiating PrEP
- •Eligible to initiate PrEP
- •Creatinine clearance > 60 ml/min as estimated by the Cockcroft-Gault equation within 6 weeks of enrollment
- •Hepatitis B surface antigen (HBsAg) negative within 6 weeks Enrollment
- •No other medical contraindications to PrEP
- •Age 18 years - 29 years
- •Willing and able to provide written informed consent
- •Report having had anal sex with a man in the previous 6 months
- •Meet any of the following risk criteria for the prior 6 months:
- •Any condomless anal sex
- •Three or more anal sex partners
- •Self-reported new STI
- •Known HIV-infected sex partner
- •Have regular access to a computer and/or a smart phone to access the internet and/or apps
- •Have the ability to send and receive text messages
- •Able to read and speak in English
排除标准
- •PrEP use within the past year (PrEP naïve participants will be prioritized).
- •Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
- •Prior or current participation in the active arm of an HIV vaccine trial
- •At Enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
- •Signs or symptoms of acute HIV infection (as described in the SSP Manual)
- •History of pathological bone fracture not related to trauma.
结局指标
主要结局
PrEP adherence among young MSM over time based on dried blood spot (DBS)
时间窗: DBS measured through week 36
PrEP adherence during follow-up based on dried blood spot (DBS) concentrations.
次要结局
- Patterns of use of Prepmate texting service over time as measured by responses to text messages.(through week 36)
- Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)(baseline and week 36)
- Perceptions of Prepmate provided via individual exit interviews(Month 10)
- The incidence of sexually-transmitted infection (STI) among all participants.(through week 36)
- Change in risk behaviors administered via CASI(baseline through week 36)
- Change in risk perception administered by CASI(baseline through week 36)
- Acceptability of Prepmate as measured by an acceptability index collected via CASI(Month 9 (or early termination))
- The number of participants who acquire HIV(week 36)
研究者
研究点 (2)
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