Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 23, 2024
Open Peer Review Period: Dec 27, 2024 - Feb 21, 2025
Date Accepted: Jun 30, 2025
(closed for review but you can still tweet)
Health system-level implementation of digital health support for people living with HIV and substance use disorders: Protocol for a cluster-randomized, stepped-wedge clinical trial
ABSTRACT
Background:
People living with HIV who are affected by substance use disorders and other social vulnerabilities are less likely to achieve and sustain viral suppression. Supporting these patients with mobile health systems can provide additional social and behavioral support that may improve HIV outcomes in these populations.
Objective:
To implement and evaluate an evidence-based digital health system (ART-C) to improve HIV viral suppression and reduce missed clinic visits within a multi-site HIV care program.
Methods:
ART-C will be implemented within eight HIV Medical Home clinics operated by Vivent Health in Colorado, Missouri, Texas, and Wisconsin. All patients receiving HIV care across the system will be invited to use a customized version of the Connections smartphone app to join a virtual community of peers living with HIV. A subset of patients with substance use disorder will be recruited to use enhanced features of the app allowing sharing of information about substance use and other social determinants of health with their care team. Effectiveness and implementation outcomes will be evaluated using a stepped-wedge clinical trial design. Effectiveness will be evaluated by comparing missed visits and viral non-suppression rates from pre- versus post-intervention. Implementation will be evaluated using a mixed-methods approach based on the RE-AIM framework.
Results:
Of the 6,710 patients with health record data available two years before the trial began, 1,723 had a substance use disorder, 2,825 missed at least two care visits, and 1,354 had at least one detectable HIV RNA test (viral load ≥ 200 copies/mL), leaving 3,816 eligible individuals. Analysis of pre-implementation data demonstrated that patients had a mean of 4.1-7.8 care visits across all 8 Vivent Health sites, with 45-70% of patients missing at least 1 visit. Patients had a mean of 2.2-4 HIV RNA tests, with 14-37% of patients across clinics with at least one non-suppressed HIV RNA test.
Conclusions:
This study will evaluate effectiveness and implementation strategies for a mobile health-based intervention to support patients affected by HIV, substance use disorder, and related challenges with engaging in care and achieving viral suppression. Clinical Trial: ClinicalTrials.gov ID NCT06109571
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