DOT Diary (D2): Developing a Mobile App With Combined Automated DOT and Daily Sexual Diary for Monitoring and Improving PrEP Adherence: DOT Diary Optimization Pilot
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- DOT Diary Mobile App Acceptability
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 understand people's experiences using this new app while taking HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.
详细描述
In the DOT Diary research project, the AiCure 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).
In the next stage of app development, the researchers are conducting this study to identify areas of the app that require refinement to maximize the acceptability and ease of use of the DOT adherence monitoring app. The researchers will assess overall acceptability and ease of use of the integrated DOT Diary (D2) app over an 8 week period.The goal of this pilot study will be to refine and optimize the app for further testing in a larger and longer pilot study 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
- Na
- 干预模型
- Single Group
- 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 anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the past 12 months:
- •Any condomless anal sex (not in a mutually monogamous relationship with an HIV-negative partner)
- •Two or more anal sex partners
- •Self-reported 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
- •Currently taking PrEP or interested in initiating 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
- •Meets local locator requirements
排除标准
- •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
- •Does not live, work or play in Atlanta Metropolitan Area, San Francisco, Alameda, Marin, Contra Costa, Santa Clara, or San Mateo Counties
- •Unable to commit to study participation for 8 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 Optimization Intervention
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet
干预措施: DOT Diary mobile app (Other)
DOT Diary Optimization Intervention
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet
干预措施: Emtricitabine / Tenofovir Disoproxil Oral Tablet (Drug)
结局指标
主要结局
DOT Diary Mobile App Acceptability
时间窗: 8 weeks
System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
DOT Diary Mobile App Ease of Use
时间窗: 8 weeks
5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) on a single question of the key attribute of ease of use of DOT Diary over 8 weeks by MSM on PrEP.
Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP
时间窗: 8 weeks
Adherence and Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP is measured by the percentage of doses taken with visual confirmation of pill ingestion
次要结局
- Assessment of Situations and Reasons for Sub-optimal Use of the App(8 weeks)
研究者
Susan Buchbinder
Director, Bridge HIV
Public Health Foundation Enterprises, Inc.