A Remote Intervention Based on mHealth and Community Health Workers for Antiretroviral Therapy Adherence in People With HIV: Pilot Randomized Controlled Trial.

Abstract

Background: Despite the availability of antiretroviral therapy (ART), only 66% of people with HIV in the United States achieve viral suppression, largely due to suboptimal ART adherence. Barriers such as limited access to care and forgetfulness impact adherence rates, which must be maintained at ≥95% to prevent viral load rebound. Combination interventions leveraging community health worker (CHW) support and mobile health (mHealth) technologies have the potential to overcome previously identified barriers and provide cost-effective support for improving adherence and viral suppression outcomes in people with HIV.

Objective: This pilot study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of remote delivery of the Community Health Worker and mHealth to Improve Viral Suppression (CHAMPS) intervention, combining the WiseApp, CHW support, and the CleverCap smart pill bottle. A secondary aim was to gather participants' feedback on the usability of the app and pill bottle as well as to better understand their experiences with remote study procedures.

Methods: This mixed methods pilot study involved 40 participants with HIV, who were randomly assigned to a control group (n=20, 50%) or the CHAMPS intervention (n=20, 50%) over 3 months. The intervention group participated in up to 12 sessions with CHWs and used the WiseApp, paired with a CleverCap smart pill bottle, to support ART adherence. Remote baseline and follow-up visits were conducted via Zoom and included surveys measuring adherence, self-efficacy, and usability (measured by Health Information Technology Usability Evaluation Scale [Health-ITUES] and Poststudy System Usability Questionnaire [PSSUQ]). Semistructured interviews explored participants' experiences with the intervention. Thematic analysis was used to identify key facilitators and barriers based on the Mobile Health Technology Acceptance Model.

Results: Remote delivery of the CHAMPS intervention was feasible, with high usability ratings for both the WiseApp and CleverCap (overall scores on Health-ITUES: mean 4.35, SD 0.58 and PSSUQ: mean 2.04, SD 1.03). In the intervention group, there were nonsignificant improvements in self-reported adherence scores (P=.29) and in self-efficacy scores (P=.07). The adjusted odds ratio for achieving undetectable viral load in the intervention group compared to the control group was 3.01 (95% CI -1.59 to 4.12), indicating a medium effect size in favor of the intervention. Overall study retention was 75% (30/40), with higher retention in the control group. Participants valued the flexibility of remote study procedures, particularly Zoom-based study visits and mailed blood sample kits. Qualitative feedback highlighted the intervention's acceptability and ability to overcome logistical barriers.

Conclusions: The remote CHAMPS pilot study demonstrated the feasibility and acceptability of combining mHealth tools with CHW support to promote medication adherence among people with HIV. While further optimization is needed to enhance its impact, this intervention shows potential for improving health outcomes in diverse underserved populations.

Trial registration: ClinicalTrials.gov NCT05938413; https://clinicaltrials.gov/study/NCT05938413.