Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Number of Participants With PrEP Adherence
研究概览
简要总结
This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM). The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
详细描述
This proposed study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis for HIV prevention among men who have sex with men (MSM). Long-term PrEP may be unnecessary for the many HIV-uninfected men who have episodic contextually defined high-risk periods, particularly when away from their home setting. Alternative dosing strategies, such as short-term fixed-interval episodic PrEP (Epi-PrEP), may be a more realistic, feasible, acceptable, and useful option with high public health impact for the majority of MSM. The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Self-identify as MSM: (1) born male who (2) has sex with men
- •Age: 18 or older
- •Sexual Risk: has had condomless anal sex with 2 or more men or any transactional sex with a man within the past 12-months.
- •Vacation: identified an upcoming period of episodic risk away (i.e. vacation) from their home city that will last at least 7 but not more than 14 days during which they anticipate having at least one high-risk sexual event.
- •Able and willing to provide informed consent
排除标准
- •HIV positive
- •Glomerular filtration rate < 60 mL/min (calculated using the Cockcroft-Gault formula)
- •Hepatitis B surface antigen positive
- •Symptoms suggestive of acute HIV seroconversion at screening or enrollment
- •Have used PrEP or PEP within the previous 3 months
- •Currently enrolled in another study involving medications, investigational drug, or medical device
- •Has other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures
研究组 & 干预措施
Intervention
Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
干预措施: emtricitabine/tenofovir (Drug)
Intervention
Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
干预措施: CBT-based counseling (Behavioral)
结局指标
主要结局
Number of Participants With PrEP Adherence
时间窗: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)
Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL.
次要结局
未报告次要终点
研究者
James Egan
Assistant Professor
University of Pittsburgh