Youth Ending the HIV Epidemic (YEHE): Protocol for a pilot of an automated directly observed therapy intervention with conditional economic incentives among young adults with HIV

PLoS One. 2023 Dec 22;18(12):e0289919. doi: 10.1371/journal.pone.0289919. eCollection 2023.

Abstract

Background: Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, and an elevated probability of disease progression and transmission. Tracking and monitoring objective measures of antiretroviral therapy (ART) adherence in real time is critical to bolster the accuracy of research data, support adherence, and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires additional effort from providers to understand individual adherence patterns. In this study, we will monitor medication-taking using a real-time objective measure of adherence that does not rely on self-report or healthcare providers for measurement.

Methods: The Youth Ending the HIV Epidemic (YEHE) study will pilot a novel automated directly observed therapy-conditional economic incentive (aDOT-CEI) intervention to improve ART adherence among youth with HIV (YWH) in California and Florida who have an unsuppressed HIV viral load. The aDOT app uses facial recognition to record adherence each day, and then economic incentives are given based on a participant's confirmed adherence. We will enroll participants in a 3-month pilot study to assess the feasibility and acceptability of the aDOT-CEI intervention using predefined metrics. During and after the trial, a subsample of the pilot participants and staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in individual in-depth interviews to explore intervention and implementation facilitators and barriers.

Discussion: YEHE will provide data on the use of an aDOT-CEI intervention to improve adherence among YWH who are not virologically suppressed. The YEHE study will document the feasibility and acceptability and will explore preliminary data to inform a trial to test the efficacy of aDOT-CEI. This intervention has the potential to effectively improve ART adherence and virologic suppression among a key population experiencing health disparities.

Trial registration: The trial registration number is NCT05789875.

MeSH terms

  • Adolescent
  • Anti-Retroviral Agents / therapeutic use
  • Directly Observed Therapy
  • HIV
  • HIV Infections* / drug therapy
  • HIV Infections* / epidemiology
  • Humans
  • Medication Adherence
  • Motivation
  • Pilot Projects
  • Retrospective Studies
  • Young Adult

Substances

  • Anti-Retroviral Agents

Associated data

  • ClinicalTrials.gov/NCT05789875

Grants and funding

This study is an NIH Funded Ending the HIV Epidemic supplment through the UCSF Center for AIDS Research (P0560916). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.