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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Infections; Substance Use Disorders
• Intervention / Treatment: Device: Connections App

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.

• Study Type: Interventional
• Enrollment (Estimated): 806
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80246
      • Vivent Health Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64130
      • Vivent Health Clinic
    • Saint Louis, Missouri, United States, 63103
      • Vivent Health Clinic
  • Texas
    • Austin, Texas, United States, 78752
      • Vivent Health Clinic
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Vivent Health Clinic
    • Kenosha, Wisconsin, United States, 53140
      • Vivent Health Clinic
    • Madison, Wisconsin, United States, 53703
      • Vivent Health Clinic
    • Milwaukee, Wisconsin, United States, 53212
      • Vivent Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Can read and write in English

• Any one of the following:

  • Measured HIV RNA greater than 200 copies/ml in the past 12 months
  • Poor retention in care, defined as 2 or more missed clinic medical HIV appointments or no attended appointments in the past year

  • 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.

If a person's HIV RNA is less than 200 copies/ml in the past months, no missed visits, and answers "no" to both screening questions on unhealthy alcohol or substance use; however, has a past or current substance use disorder or treatment services noted in the patient's problem list, this person is considered eligible.

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 appearing to lack capacity to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Virologic Failure	Using the stepped-wedge design to assess Effectiveness, each site will function as its own control or "usual care" group prior to implementation of Connections. (Aim 1)	baseline and 12 months for each clinic
Percentage of Vivent Health HIV patients who have downloaded and used Connections	The primary Reach measure will be the percentage of Vivent Health HIV patients who have downloaded and used Connections, including sex, racial, and ethnic characteristics. (Aim 2)	up to 4 years
Incremental Cost per Quality-Adjusted Life-Year Gained through Increased Antiretroviral Adherence	Setup, operating, and healthcare costs of implementation in relationship to its effectiveness in preventing virologic failure and missed clinic appointments. The primary incremental cost-effectiveness ratio (ICER) will be the incremental cost per quality-adjusted life-year gained through increased antiretroviral adherence (Aim 3)	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Missed Clinic Appointments	Using the stepped-wedge design to assess Effectiveness, each site will function as its own control or "usual care" group prior to implementation of Connections. (Aim 1)	baseline and 12 months for each clinic
Number of "meaningful use" weeks	Adoption at the patient level is based on research-driven metrics of "meaningful use" for mHealth, defined as a patient accessing any part of Connections beyond the home page during a given week in the 12-month period after downloading the app. (Aim 2)	up to 12 months
Days of "meaningful use" per week	Adoption at the patient level is based on research-driven metrics of "meaningful use" for mHealth, defined as a patient accessing any part of Connections beyond the home page during a given week in the 12-month period after downloading the app. (Aim 2)	up to 12 months
Change in "meaningful use" after a private message	The investigators will assess whether receiving a message through Connections (for example, a private message from a case manager after a missed appointment) is associated with subsequent patient use of Connections. (Aim 2)	before and after messaging (any time up to 12 months)
Percent Participant Follow up in the 6-month post-intervention period	Maintenance is defined as follow up on the effectiveness measures (viral load and missing-visit rates) in the 6-month post-intervention period. (Aim 2)	clinic follow up in the 6-month post-intervention period (up to 18 months for participant)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ryan Westergaard, UW School of Medicine and Public Health; Principal Investigator: Andrew Quanbeck, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: mHealth; Viral Suppression
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2023-0938; A534265 (Other Identifier: UW, Madison); SMPH/MEDICINE/INFECT DIS (Other Identifier: UW Madison); 1R01DA055527-01A1 (U.S. NIH Grant/Contract); Protocol Version 11/1/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No