Youth Ending the HIV Epidemic - Automated Directly Observed Therapy Pilot: Improving HIV Care Among Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Acceptability: System Usability Scale (SUS) >68, Considered Above Average and Acceptable
研究概览
简要总结
Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, an increased risk of antiretroviral therapy (ART) nonadherence and virologic failure, and a high probability of disease progression and transmission. Tracking and monitoring objective measures of ART adherence in real time is critical to strategies to support adherence and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires extra effort from providers to understand adherence patterns, making it difficult for providers to accurately determine how to support their patients in real time. In the proposed interventional study, the investigators aim to pilot test an automated directly observed therapy intervention paired with conditional economic incentives to improve ART adherence among youth living with HIV (YLWH) (18-29 years-old) who have an unsuppressed HIV viral load.
Aim 1: Conduct a pilot study to assess feasibility and acceptability of the use of automated directly observed therapy with conditional economic incentives (aDOT-CEI) among YLWH (aged 18-29; N= 30) at AIDS Healthcare Foundation (AHF) clinics in California and Florida. Primary outcomes will be feasibility and acceptability, assessed using predefined feasibility metrics and acceptability surveys at three months.
Aim 2: Explore experiences of YLWH and staff/providers with the aDOT-CEI intervention and implementation facilitators and barriers. The investigators will conduct in-depth qualitative interviews with a sample of YLWH from Aim 1 and staff/providers purposively selected from participating AHF clinics to explore intervention experiences, potential influences on ART adherence, individual-level and clinic-level barriers and facilitators to intervention implementation, and suggested refinements for a future efficacy trial.
The investigators hypothesize that the aDOT-CEI intervention to improve ART adherence among YLWH will have high feasibility and acceptability.
详细描述
Automated directly observed therapy (aDOT) is an innovative technology that uses artificial intelligence (AI) with computer vision and deep learning algorithms to track and support adherence through a smartphone. Additionally, aDOT provides a seamless and convenient platform for providing Conditional Economic Incentives (CEIs) because it monitors real-time adherence to automatically determine who can receive incentives. For the design and development of the mobile health app, the investigators have partnered with AiCure to use an existing HIPAA-compliant mobile health app. The investigators will invite YLWH from AIDS Healthcare Foundation (AHF) sites in CA and FL to form the study Youth Advisory Panel (YAP) and seek their input on the AiCure app. The investigators will work with AiCure to implement any required changes to the app that have emerged from formative research. The app will then be piloted with YLWH (aged 18-29; N= 30) who will use the platform for a period of 3 months (Aim 1).
The app will record video of the participant taking their HIV medication in order to monitor the participant's medication adherence. Participants will complete online surveys at baseline and 3 months. The investigators will have monthly check-ins with participants which the investigators will assess app use and help increase study engagement. The investigators will measure feasibility and acceptability through app paradata (i.e., app use information) and self-report in surveys (baseline, 3 months). And the investigators will use adherence-related medical record data from AHF to compare against adherence monitored by the AiCure app.
Following completion of the pilot, the investigators will conduct in-depth interviews (IDIs) with YLWH and staff /providers purposively selected from participating AHF clinics (Aim 2). Interviews will explore intervention experiences, potential influences on current and long-term ART adherence, unaddressed adherence barriers and the potential benefit of features (e.g., reminders), individual-level and clinic-level barriers and facilitator to intervention implementation, assess ease of use of aDOT-CEI, likes and dislikes, and suggested modifications for a future efficacy trial.
This interventional pilot study will assess the feasibility and acceptability of aDOT-CEI and will provide preliminary data to inform an R01 to test the efficacy of aDOT-CEI in addressing disproportionately low viral suppression among YLWH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 29 years of age
- •Have access to a smartphone
- •Can speak and read English
- •Client is at an AHF clinic in California or Florida
- •Client has an unsuppressed HIV viral load at least 3 months post HIV diagnosis
- •Client is on once daily oral antiretroviral therapy
- •Consent to participate in the proposed study
排除标准
- •YLWH who are newly HIV diagnosed in the past 3 months
- •Smartphone is a Samsung galaxy s21 or iPhone 5SE (app is not supported by these phones)
结局指标
主要结局
Acceptability: System Usability Scale (SUS) >68, Considered Above Average and Acceptable
时间窗: 3 months
The acceptability of the AiCure Mobile application will be through the System Usability Scale (SUS). The intervention was considered acceptable if ≥80% had a SUS score \>68, which is considered above average acceptability.
Acceptability: Client Satisfaction Questionnaire (CSQ-8) Score of ≥17, Considered Above Average and Acceptable
时间窗: 3 months
Client satisfaction will be measured using a Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item scale with higher values indicating higher satisfaction. Acceptability was set as a cutoff of 80% having a score of ≥17, which is the score cutoff considered above average and acceptable for this measure.
Acceptability: Likelihood of Recommending the Study to a Friend (Extremely, Very)
时间窗: 3 months.
Recommend study to a friend. 7-point Likert Scale of how likely participants are to recommend the study to a friend. The intervention was considered acceptable if ≥80% reported likely or very likely to recommend.
Feasibility: Rate of Participant Retention
时间窗: 3 Months
Rate of Participant Retention will be calculated as the percent of those who were retained in the study and completed the final survey.
Feasibility: Mean Logins Per Week
时间窗: 3 months
Mobile app data from the AiCure Application (paradata) will be used to measure the number of participant logins per week and thereby calculate mean logins per participant per week.
Feasibility: Mean Number of Seconds in App Per Day
时间窗: 3 months
Mobile app data from the AiCure Application (Paradata) will be used to measure the number of seconds each participant spends in that app each day, thereby calculating the mean number of seconds in app per day per participant.
Feasibility: Mean Percent Doses a Participant May Have "Falsified" Med-taking
时间窗: 3 months
The AiCure mobile application platform uses an artificial intelligence or AI platform to recognize dosing patterns recorded by users that do not correspond to what has been defined as 'normal' dosing by the AI. The AI accordingly flags any video recording featuring abnormal dosing for review by the AiCure Video Review team. Upon confirmation of abnormal dosing, the AiCure Video Review team notifies the research coordinator in the form of a "Red Alert". Each of these "Red Alerts" message will be counted as an event of intentional nonadherence, and the mean number of times a participant may have "falsified" medication taking will be calculated and compared against the number of 'normal' doses.
Acceptability: Satisfaction With the App+Incentives (Mostly, Very)
时间窗: 3 months
Client satisfaction with the app+incentives. 7-point Likert Scale values from 1-7 with lower values corresponding to least satisfaction and higher values corresponding to greater satisfaction.
次要结局
- Mean Percent Adherence Over the Study Period (Excluding Those Lost to Follow up)(3 months)
- Monitoring of Behavior: Number of Seconds in App(3 months)
- Monitoring of Behavior: Frequency of App Related Issues(3 months)
- Median Self-Reported Adherence Score at Study Exit(3 months)
- Monitoring of Behavior: Ease of Use(3 months)