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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
433
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.
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
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)
Time frame: 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)
Time frame: 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)
Time frame: up to 12 months
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)
Time frame: 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)
Time frame: up to 12 months
Days of "meaningful use" per week
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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
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)
Time frame: 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)
Time frame: 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)
Time frame: clinic follow up in the 6-month post-intervention period (up to 18 months for participant)