Clinical trial NCT06109571: Clinic-level Implementation of mHealth to Improve HIV Viral Suppression for Patients With Substance Use Disorders
Official title: Clinic-level Implementation of mHealth to Improve HIV Viral Suppression for Patients With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: HIV Infections
Substance Use Disorders
Keywords: Viral Suppression
mHealth
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-10-31
Enrollment: 806
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge, one-way crossover, cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of Virologic Failure
timeFrame: baseline and 12 months for each clinic
measure: Percentage of Vivent Health HIV patients who have downloaded and used Connections
timeFrame: up to 4 years
measure: Incremental Cost per Quality-Adjusted Life-Year Gained through Increased Antiretroviral Adherence
timeFrame: up to 12 months
Secondary outcomes:
measure: Number of Missed Clinic Appointments
timeFrame: baseline and 12 months for each clinic
measure: Number of "meaningful use" weeks
timeFrame: up to 12 months
measure: Days of "meaningful use" per week
timeFrame: up to 12 months
measure: Change in "meaningful use" after a private message
timeFrame: before and after messaging (any time up to 12 months)
measure: Percent Participant Follow up in the 6-month post-intervention period
timeFrame: clinic follow up in the 6-month post-intervention period (up to 18 months for participant)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Vivent Health Clinic
state: Colorado
city: Kansas City
country: United States
facility: Vivent Health Clinic
state: Missouri
city: Saint Louis
country: United States
facility: Vivent Health Clinic
state: Missouri
city: Austin
country: United States
facility: Vivent Health Clinic
state: Texas
city: Green Bay
country: United States
facility: Vivent Health Clinic
state: Wisconsin
city: Kenosha
country: United States
facility: Vivent Health Clinic
state: Wisconsin
city: Madison
country: United States
facility: Vivent Health Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Vivent Health Clinic
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Ryan Westergaard
role: PRINCIPAL_INVESTIGATOR
affiliation: UW School of Medicine and Public Health
name: Andrew Quanbeck
role: PRINCIPAL_INVESTIGATOR
References: