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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06109571
• Other study ID #: 2023-0938
• Secondary ID: 1R01DA055527-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: March 2027

Study information

• Verified date: December 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 806
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Vivent Health Clinic	Austin	Texas
United States	Vivent Health Clinic	Denver	Colorado
United States	Vivent Health Clinic	Green Bay	Wisconsin
United States	Vivent Health Clinic	Kansas City	Missouri
United States	Vivent Health Clinic	Kenosha	Wisconsin
United States	Vivent Health Clinic	Madison	Wisconsin
United States	Vivent Health Clinic	Milwaukee	Wisconsin
United States	Vivent Health Clinic	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)