Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire
研究概览
简要总结
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).
详细描述
PrEPSteps is a novel, smartphone-based behavioral intervention that delivers PrEP adherence messages in response to detected PrEP ingestion via an innovative digital pill. PrEPSteps comprises 1) an adaptation of LifeSteps, an evidence-based medication adherence behavioral intervention, with smartphone-delivered booster sessions, 2) messages of contingent reinforcement and corrective feedback, and 3) stimulant use screening, brief assessment, and referral to treatment. In this K23, the investigators will first refine and inform the specification of PrEPSteps with a series of focus groups. The investigators will next test the feasibility, acceptability and potential for an effect of PrEPSteps to boost PrEP adherence in a pilot randomized controlled trial of men who have sex with men (MSM) with stimulant use. Finally, the investigators will conduct qualitative interviews among participants who used PrEPSteps to understand the participant response to living with the intervention.
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
- 否
入选标准
- •Cisgender MSM
- •Moderate to severe non-alcohol substance use disorder
- •Self-reported missed PrEP doses (> or equal to 2 doses in 1 week over past 3 months)
- •HIV negative
- •On PrEP or initiating PrEP
- •Has qualifying laboratory testing: Cr clearance, HBV, liver function tests
- •Owns a smartphone with Android or iOS
- •Age 18 or older
排除标准
- •Non-English speaker
- •HIV positive
- •History of Crohn's disease or ulcerative colitis
- •History of gastric bypass, bowel stricture
- •History of GI malignancy or radiation to abdomen
- •Unable/unwilling to ingest a digital pill
- •Allergy to gelatin, silver or zinc (components of the digital pill)
- •Does not qualify for PrEP (abnormal liver function, or Cr Clearance <60)
研究组 & 干预措施
PrEPsteps
Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.
干预措施: Digital pill (Device)
PrEPsteps
Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.
干预措施: Truvada (Drug)
Control
Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.
干预措施: Digital pill (Device)
Control
Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.
干预措施: Truvada (Drug)
PrEPsteps
Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.
干预措施: PrEPsteps (Behavioral)
结局指标
主要结局
Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire
时间窗: three month study visit
Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm.
次要结局
- Potential of PrEPsteps to Improve Adherence(three month study visit)
- Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm(three month visit)
研究者
Peter R Chai MD
Emergency Medicine Physician
Brigham and Women's Hospital