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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA055527-01A1 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 11/14/2024 | Other Identifier | UW Madison | |
| A534265 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/INFECT DIS | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Westergaard | UW School of Medicine and Public Health | Principal Investigator |
| Andrew Quanbeck | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vivent Health Clinic | Denver | Colorado | 80246 | United States | ||
| Vivent Health Clinic |
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Stepped-wedge, one-way crossover, cluster randomized trial
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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) |
| Kansas City |
| Missouri |
| 64130 |
| United States |
| Vivent Health Clinic | St Louis | Missouri | 63103 | United States |
| Vivent Health Clinic | Austin | Texas | 78752 | United States |
| Vivent Health Clinic | Green Bay | Wisconsin | 54301 | United States |
| Vivent Health Clinic | Kenosha | Wisconsin | 53140 | United States |
| Vivent Health Clinic | Madison | Wisconsin | 53703 | United States |
| Vivent Health Clinic | Milwaukee | Wisconsin | 53212 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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