DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect of DOT Diary App on PrEP Adherence
研究概览
简要总结
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is time to take their medication, and uses motion-sensing technology to visually and automatically confirm the pill was swallowed. The goal of this study is to assess the impact of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.
详细描述
In the DOT Diary research project, the AiCure automated directly observed therapy (aDOT) smartphone app has been adapted for use in monitoring and supporting HIV pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). The aDOT app uses automated directly observed therapy (DOT) that use the smartphone camera and artificial intelligence software to confirm that the right person is taking the right medication at the right time. A sexual diary has been integrated into the aDOT app to assist YMSM in understanding whether they are receiving protection from PrEP for individual sexual episodes, and when it is particularly important to take PrEP (e.g. after a sexual episode). Specifically, the sexual diary allows participants to track sexual encounters, sexual behaviors that occurred in each encounter, and rating characteristics of partners. The app provides a calendar displaying all days in which PrEP medication was taken, and all days in which sexual activity occurred, allowing participants to see coverage of sexual encounters with PrEP. Based on pharmacokinetic and pharmacodynamic data from prior PrEP trials, the app will also indicate the estimated level of protection achieved from PrEP (e.g. low, medium, high), and also provide personalized messages on the additional numbers of doses needed to maximize protection.
In the next stage of app development and assessment, the researchers will conduct the DOT Diary Longitudinal Pilot to assess the impact of the app on PrEP adherence as measured by pharmacokinetic measures of PrEP use (tenofovir diphosphate [TFV-DP] and emtricitabine triphosphate [FTC-TP] levels in dried blood spots [DBS]). The researchers will also assess the concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary, and the acceptability and ease of use of the app over a longer (24-week) period. This pilot study will allow evaluation and further refinement of the app in preparation for testing in a larger efficacy trial among YMSM at risk for HIV acquisition. The researchers will conduct this pilot protocol among YMSM in Atlanta and San Francisco Bay Area, two metropolitan regions heavily impacted by HIV, yet differing in sociodemographics, as well as in the availability and uptake of HIV prevention services, including PrEP. These diverse research locations will allow collection of data to inform app development among a broad group of YMSM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identifies as a man
- •Age 18-35 at enrollment
- •Reports having insertive or receptive anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the last 12 months:
- •Any condomless anal sex outside of a mutually monogamous relationship with an HIV-negative partner
- •Two or more anal sex partners
- •Self-reported sexually transmitted infection (STI; gonorrhea, chlamydia, syphilis)
- •Having a known HIV-positive sexual partner
- •HIV-negative as determined by a negative 4th generation HIV test at screening and negative rapid 4th generation test at enrollment
- •Willing to initiate PrEP
- •Eligible to take PrEP
- •Creatinine clearance ≥60 ml/min as estimated by Cockcroft-Gault equation at screening
- •Hepatitis B surface antigen (HBsAg) negative
- •Willing and able to provide written informed consent
- •Able to read and speak English
- •Smartphone ownership compatible with DOT Diary app
- •Meets local locator requirements
- •Lives, works or plays in Atlanta Metropolitan Area, San Francisco, Alameda, Marin, Contra Costa, Santa Clara, or San Mateo Counties
排除标准
- •PrEP use within the past 4 months (PrEP naive participants will be prioritized)
- •Any reactive HIV test at screening or enrollment
- •Signs or symptoms of acute HIV infection at screening or enrollment
- •History of pathological bone fracture not related to trauma
- •Taking nephrotoxic medications
- •History of participation in the active arm of an HIV vaccine trial
- •In a mutually monogamous sexual relationship with an HIV-negative partner for the past 12 months
- •Unable to commit to study participation for 24 weeks
- •Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
研究组 & 干预措施
DOT Diary Intervention
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
干预措施: Emtricitabine / Tenofovir Disoproxil Oral Tablet (Drug)
DOT Diary Intervention
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
干预措施: DOT Diary mobile app (Other)
DOT Diary Control
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
干预措施: Emtricitabine / Tenofovir Disoproxil Oral Tablet (Drug)
结局指标
主要结局
Effect of DOT Diary App on PrEP Adherence
时间窗: 24 weeks
Measurement of PrEP Adherence as measured by TFV-DP level \>=700 fmol/punch in DBS among young MSM initiating PrEP
DOT Diary Mobile App Acceptability
时间窗: 24 weeks
Combined descriptive analysis of key attributes of acceptability of DOT Diary over 24 weeks by YMSM on PrEP, in order to identify potential improvements to the app to maximize acceptability. This was measured using the System Usability Scale, with minmum value of 0 and maximum value of 100. This is a scale that uses a 10-item questionnaire with a 5-point Likert scale from strongly agree to strongly disagree. Scores are summed and the final score is multiplied by 2. Higher scores mean a better outcome.
Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App
时间窗: 6, 12, 18, 24 weeks
As a measure of concordance between DBS measurements and aDOT-based assessments of PrEP adherence: Number of specimens with \< 700 fmol/punch or \>= 700 fmol/punch agreement with number of participants reporting PrEP use \< 4 days/week or 4-7 days/week at weeks 6, 12, 18, 24
DOT Diary Mobile App Ease of Use
时间窗: 24 weeks
Descriptive analysis of key attribute of ease of use of DOT Diary over 24 weeks by YMSM on PrEP. Participants were asked if the DOT Diary app was easy to use and answered using a Likert Scale from 1= Strongly disagree, 2= Disagree, 3= Neutral, 4= Agree, 5= Strongly agree. A higher score indicates a better outcome.
次要结局
- PrEP Coverage of Sexual Acts (Prevention-effectiveness Adherence) as Measured by DOT Diary(6, 12, 18, 24 weeks)
研究者
Susan Buchbinder
Director, Bridge HIV
Public Health Foundation Enterprises, Inc.