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

NCT06109571 | Enrolling By Invitation FDA Device

• 5 other identifiers: 2023-09381R01DA055527-01A1Protocol Version 11/14/2024A534265SMPH/MEDICINE/INFECT DIS
• Study Type: interventional
• Target: 806
• Locations: 1 country
• Sites: 8

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.

Conditions

HIV Infections; Substance Use Disorders

Keywords

Viral Suppression; mHealth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of Missed Clinic Appointments

  baseline and 12 months for each clinic

• Number of "meaningful use" weeks

  up to 12 months

• Days of "meaningful use" per week

  up to 12 months

• Change in "meaningful use" after a private message

  before and after messaging (any time up to 12 months)

• Percent Participant Follow up in the 6-month post-intervention period

  clinic follow up in the 6-month post-intervention period (up to 18 months for participant)

Study Arms (4)

Group 1: mHealth Implementation

EXPERIMENTAL

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

Group 2: mHealth Implementation

EXPERIMENTAL

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

Group 3: mHealth Implementation

EXPERIMENTAL

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

Group 4: mHealth Implementation

EXPERIMENTAL

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

Interventions

Connections App DEVICE

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 1: mHealth Implementation; Group 2: mHealth Implementation; Group 3: mHealth Implementation; Group 4: mHealth Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (8)

Vivent Health Clinic

Denver, Colorado, 80246, United States

Location

Vivent Health Clinic

Kansas City, Missouri, 64130, United States

Location

Vivent Health Clinic

St Louis, Missouri, 63103, United States

Location

Vivent Health Clinic

Austin, Texas, 78752, United States

Location

Vivent Health Clinic

Green Bay, Wisconsin, 54301, United States

Location

Vivent Health Clinic

Kenosha, Wisconsin, 53140, United States

Location

Vivent Health Clinic

Madison, Wisconsin, 53703, United States

Location

Vivent Health Clinic

Milwaukee, Wisconsin, 53212, United States

Location

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ryan Westergaard

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

• Andrew Quanbeck

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge, one-way crossover, cluster randomized trial

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (8)