Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Feasibility of Digital Pills to Measure PrEP Adherence
研究概览
简要总结
This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of using digital pills in this study population as well as understand the acceptability of digital pills for adherence measurement using semi-structured individual interviews. Additionally, the investigators will measure adherence over time, as well as episodes of suboptimal PrEP adherence.
详细描述
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will complete a quantitative assessment on their history fo substance use, sexual risk and PrEP adherence, and be trained to use the digital pill for 90 days and instructed to take PrEP daily during the course of the study. Participants will return each month for a study visit to assess their use of the technology. At study visit 1 and 3, we will obtain dried blood spots (DBS) to measure drug levels and to confirm adherence detected by the digital pill. The investigators will also obtain drugs of abuse screens from DBS. At the final study visit (3 months), participants will undergo a semi-structured qualitative interview to understand the user response to digital pills.
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
- 否
入选标准
- •MSM (cisgender male)
- •Self-reported use of non-alcohol substances of abuse in past 6 months
- •Currently taking PrEP
- •Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
- •Age 18 or older
排除标准
- •Does not speak English
- •HIV positive
- •Identifies as transgender
- •Estimated creatinine clearance <60ml/min
- •Active hepatitis B treatment
- •Does not own a smartphone
- •Taking proton pump inhibitors
- •History of Crohn's disease or ulcerative colitis
- •History of bowel surgery, gastric bypass, bowel stricture
- •History of GI malignancy or radiation to abdomen
- •Unable/unwilling to ingest digital pill
研究组 & 干预措施
Digital Pills
Digital Pills containing Truvada ingested once daily as PrEP
干预措施: Truvada (Drug)
Digital Pills
Digital Pills containing Truvada ingested once daily as PrEP
干预措施: Digital pill (Device)
结局指标
主要结局
Feasibility of Digital Pills to Measure PrEP Adherence
时间窗: Months 1, 2, and 3
Participants' engagement with the digital pill system (DPS) was measured over the 90-day study period. The percentages for the total expected ingestions recorded by DPS each month were compared.
次要结局
- Dried Blood Spot Correlation With Digital Pill Adherence(Months 1 and 3)
- Digital Pill Performance - System Accuracy(Months 1, 2, and 3)
- Digital Pill Performance - Number of Recorded Ingestions(Months 1, 2, and 3)
- Digital Pill Performance - Manually Reported Ingestions(Months 1, 2, and 3)
- Digital Pill Performance - Successful Operation of System(Months 1, 2, and 3)
研究者
Peter R Chai
Emergency Medicine Physician
Fenway Community Health