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

University of Wisconsin (UW)

Status: Invitation-only

Conditions: Substance Use Disorders; HIV Infections

Treatments: Device: Connections App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06109571

Protocol Version 11/14/2024 (Other Identifier)

SMPH/MEDICINE/INFECT DIS (Other Identifier)

1R01DA055527-01A1 (U.S. NIH Grant/Contract)

2023-0938

A534265 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 806 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to read, write and speak English

• Receives HIV Disease Care at Vivent Health

• At risk for poor engagement in HIV care, as evidenced by any one of the following:

  • Prior missed clinic visits

  • Poor adherence to medical treatment defined as 2 or more missed doses of medication in a month

  • Unhealthy alcohol or other substance use, as evidenced by a diagnosis of substance use disorder on the patient's problem list, a prior referral to alcohol or substance abuse services, or answering "yes" to one or both of the following screening questions:

    • Has drinking alcohol or using drugs (including marijuana) ever caused problems in your life, such as damaging relationships, causing you to not meet obligations at work, or getting in trouble with the law?
    • Are you currently participating in any treatment or counseling because of problems caused by drug use? This can include groups like N. A., or one-on-one interaction with a doctor or therapist.

Exclusion criteria

• Individuals who do not currently have a smartphone or are unwilling to obtain a smartphone will not be able to participate in this study.
• People who are unwilling to download and activate the Connections app.
• People with cognitive or other impairment that precludes the capacity to consent.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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806 participants in 4 patient groups

Group 1: mHealth Implementation

Experimental group

Description:

First 2 sites begin enrollment. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.

Treatment:

Device: Connections App

Group 2: mHealth Implementation

Experimental group

Description:

Next 2 sites begin enrollment 6 months after Group 1. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.

Treatment:

Device: Connections App

Group 3: mHealth Implementation

Experimental group

Description:

Next 2 sites begin enrollment 6 months after Group 2. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.

Treatment:

Device: Connections App

Group 4: mHealth Implementation

Experimental group

Description:

Next 2 sites begin enrollment 6 months after Group 3. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.

Treatment:

Device: Connections App