Young people, ART, and adherence

Background: Adherence to antiretroviral therapy (ART) among young people living with human immunodeficiency virus (YPLWH) is lower than in other age-groups. Electronic monitoring devices may improve adherence behavior in chronic diseases. We hypothesized that use of electronic monitoring devices paired with text message reminders and adherence feedback may improve viral suppression among YPLWH. Methods/design: An individual randomized, controlled trial will be conducted from September 2023 to January 2025 in Harare, Zimbabwe. YPLWH aged 16 to 30 years, with a viral load (VL) > 200 copies/mL will be enrolled from human immunodeficiency virus outpatient clinics. Participants will be randomized to intervention or standard of care (existing enhanced adherence counseling services) and followed up for 9 months. Participants randomized to the intervention arm will be asked to keep and take their ART tablets daily from an EMD that is configured to send text message reminders to their mobile telephone if no pill box opening event has been recorded 30-minutes after scheduled intake time. Monthly focused individual and in-person adherence feedback sessions will be conducted to discuss EMD-recorded adherence. The primary outcome is proportion of participants with viral suppression (VL < 50 copies/mL) at 6 months. Secondary outcomes are proportion of participants with VL < 50 copies/mL at 9 months, mean adherence to ART at 6 and 9 months, change of ART regimen, and exploration of adherence patterns using machine learning. A mixed methods process evaluation will be conducted concurrently with the trial to explore feasibility, fidelity, and acceptability of the intervention in participants randomized to the intervention arm. Conclusion: Findings of this trial will provide evidence for the effectiveness and feasibility of digital adherence interventions for young people taking long-term therapies.