Feasibility and Acceptability of a Remote mHealth and CHW-Based Intervention for ART Adherence: Results from the CHAMPS Pilot (Preprint)
Authors: Shourya Shivesh , Liu Jianfang , McInerney Sophia , Casimir Trinity , Kenniff James , Kershaw Trace , Batey David Scott , Schnall Rebecca 
Published: November 2024

BACKGROUND

Despite the availability of antiretroviral therapy (ART), only about 66% of people with HIV (PWH) in the United States achieve viral suppression, largely due to suboptimal ART adherence. Barriers such as stigma, limited access to care, and forgetfulness significantly impact adherence rates, which must be maintained at 95% or higher to prevent viral load rebound and HIV transmission. 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 PWH.

OBJECTIVE

This pilot study evaluated the feasibility, acceptability, and preliminary efficacy of remote delivery of the CHAMPS intervention, combining the WiseApp, CHW support, and the CleverCap smart pill bottle. A secondary aim was to gather participant 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 (n = 20 control, n = 20 intervention) with HIV, randomized to a control condition or the CHAMPS intervention over three months. The intervention group participated in sessions with CHWs and used the WiseApp, paired with a CleverCap smart pill bottle, to support ART adherence. Remote baseline and follow-up visits, conducted via HIPAA-compliant Zoom, included surveys measuring adherence (SRSI), self-efficacy (HIV-ASES), and usability (Health-ITUES, PSSUQ). Semi-structured 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 (MHTAM).

RESULTS

Remote delivery of the CHAMPS intervention is feasible, with high usability ratings for both the WiseApp and CleverCap (Health-ITUES overall score: mean = 4.35, SD ± 0.58; PSSUQ overall score: mean = 2.04, SD ± 1.03). There were non-significant improvements in self-reported adherence (SRSI: intervention group baseline mean = 4.90, follow-up mean = 5.25, p = 0.288) and self-efficacy (HIV-ASES overall score: intervention group baseline mean = 8.08, follow-up mean = 8.78, p = 0.072). The adjusted odds ratio (OR) for achieving undetectable viral load in the intervention group compared to the control group was 3.01, indicating a medium effect size in favor of the intervention. 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 its ability to overcome logistical barriers.

CONCLUSIONS

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

CLINICALTRIAL

ClinicalTrials.gov ID: NCT05938413