Clinical trial NCT05789875: Youth Ending the HIV Epidemic
Official title: Youth Ending the HIV Epidemic - Automated Directly Observed Therapy Pilot: Improving HIV Care Among Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Mobile Health
Young Adults
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: AiCure
name: RTI International
name: National Institute of Mental Health (NIMH)
First posted: 2023-03-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Feasibility: Rate of Participant Retention
timeFrame: 3 Months
measure: Feasibility: Mean Logins Per Week
timeFrame: 3 months
measure: Feasibility: Mean Number of Seconds in App Per Day
timeFrame: 3 months
measure: Feasibility: Mean Percent Doses a Participant May Have "Falsified" Med-taking
timeFrame: 3 months
measure: Acceptability: System Usability Scale (SUS) >68, Considered Above Average and Acceptable
timeFrame: 3 months
measure: Acceptability: Client Satisfaction Questionnaire (CSQ-8) Score of ≥17, Considered Above Average and Acceptable
timeFrame: 3 months
measure: Acceptability: Likelihood of Recommending the Study to a Friend (Extremely, Very)
timeFrame: 3 months.
measure: Acceptability: Satisfaction With the App+Incentives (Mostly, Very)
timeFrame: 3 months
Secondary outcomes:
measure: Mean Percent Adherence Over the Study Period (Excluding Those Lost to Follow up)
timeFrame: 3 months
measure: Median Self-Reported Adherence Score at Study Exit
timeFrame: 3 months
measure: Monitoring of Behavior: Number of Seconds in App
timeFrame: 3 months
measure: Monitoring of Behavior: Ease of Use
timeFrame: 3 months
measure: Monitoring of Behavior: Frequency of App Related Issues
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Center for AIDS Prevention Studies
state: California
Study officials:
affiliation: UCSF School of Medicine, Division of Prevention Science
name: Parya Saberi, PharmD
role: PRINCIPAL_INVESTIGATOR
References: