Clinic-level Implementation of mHealth to Improve HIV Viral Suppression for Patients With Substance Use Disorders
NCT ID: NCT06109571
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
806 participants
INTERVENTIONAL
2023-12-04
2027-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Group 1: mHealth Implementation
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.
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.
Group 2: mHealth Implementation
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.
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.
Group 3: mHealth Implementation
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.
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.
Group 4: mHealth Implementation
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* People who are unwilling to download and activate the Connections app.
* People with cognitive or other impairment that precludes the capacity to consent.
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Ryan Westergaard
Role: PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health
Andrew Quanbeck
Role: PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health
Locations
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Vivent Health Clinic
Denver, Colorado, United States
Vivent Health Clinic
Kansas City, Missouri, United States
Vivent Health Clinic
St Louis, Missouri, United States
Vivent Health Clinic
Austin, Texas, United States
Vivent Health Clinic
Green Bay, Wisconsin, United States
Vivent Health Clinic
Kenosha, Wisconsin, United States
Vivent Health Clinic
Madison, Wisconsin, United States
Vivent Health Clinic
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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Protocol Version 11/14/2024
Identifier Type: OTHER
Identifier Source: secondary_id
A534265
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/INFECT DIS
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0938
Identifier Type: -
Identifier Source: org_study_id
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