NCT06109571

Clinic-level Implementation of mHealth to Improve HIV Viral Suppression for Patients With Substance Use Disorders

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 806 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current protocol aims to enroll up to 806 participants from 8 study sites in a clinic-supported intervention which will connect them to Vivent Health care team and a cohort of peer mentors for a year-long intervention period to support patient HIV care to maintain viral suppression and clinic appointments.

Detailed description

This protocol describes the implementation phase of a 5-year NIH-funded research project designed to evaluate the effectiveness of an innovative clinic-level intervention featuring an evidence-based, HIPAA-compliant mobile health (mHealth) application ("Connections," a smartphone app operated by the company CHESS Health) and peer-driven social support. The goal of this project is to implement and evaluate an evidence-based mHealth system to improve HIV viral suppression and reduce missed clinic visits within a multi-site, comprehensive HIV care program. Connections is a mobile health app developed by CHESS Health to support patients with substance use disorders. The investigators hypothesize that implementation of an adapted version of Connections within an established network of HIV clinical practices will reduce the occurrence of the primary outcome of virologic failure and the secondary outcome of missed clinic appointments. The specific aims are: 1. To test the effectiveness of Connections using a stepped-wedge randomized trial. 2. To evaluate the implementation of Connections within the HIV Medical Home Model. Using the RE-AIM framework, we will analyze patient-level, provider-level, and clinic-level factors that influence the reach, implementation, adoption, and maintenance of Connections in HIV practices. 3. To systematically measure costs of implementation of Connections in relationship to its benefits related to preventing virologic failure and missed clinic appointments.

Conditions

• HIV Infections
• Substance Use Disorders

Interventions

Type	Name	Description
DEVICE	Connections App	The Connections app was developed for patients with substance use disorders or unhealthy substance use and adapted to include HIV support. For this study, it has been modified to provide additional resources to support patients engaged in HIV care. Connections' core features include agency-specific informational resources compiled in a resource center, patient self-monitoring through weekly check-in surveys, discussion rooms, and private messaging.

Timeline

• Start date: 2023-12-04
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2023-10-31
• Last updated: 2025-09-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study