Youth Ending the HIV Epidemic - Automated Directly Observed Therapy Pilot: Improving HIV Care Among Youth
Trial ID: NCT05789875
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-01-31
Completion date: 2023-09-08
Sponsor: University of California, San Francisco
Collaborators: AiCure; RTI International; National Institute of Mental Health (NIMH)
Conditions: HIV/AIDS; Mobile Health; Young Adults
Interventions: aDOT-CEI
Locations: UCSF Center for AIDS Prevention Studies
Countries: United States
Enrollment: 28
Age range: 18 Years - 29 Years
Sex: ALL

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.

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)

Outcomes:
Feasibility: Rate of Participant Retention; Feasibility: Mean Logins Per Week; Feasibility: Mean Number of Seconds in App Per Day; Feasibility: Mean Percent Doses a Participant May Have "Falsified" Med-taking; Acceptability: System Usability Scale (SUS) >68, Considered Above Average and Acceptable; Acceptability: Client Satisfaction Questionnaire (CSQ-8) Score of ≥17, Considered Above Average and Acceptable; Acceptability: Likelihood of Recommending the Study to a Friend (Extremely, Very); Acceptability: Satisfaction With the App+Incentives (Mostly, Very)