Cabenuva Injection Tracking in CHORUS

Study Overview
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Brief Summary
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This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.

Detailed Description
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A novel long-acting HIV antiretroviral therapy has recently been approved by the FDA: cabotegravir and rilpivirine delivered through intramuscular injection. These injections should be administered monthly, on the same day of the month as the initiation injections, up to 7 days before or after the date of the scheduled monthly injection visit. This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. Providers in the intervention group will receive alerts to remind them when patients are due for their injections, or if they missed their treatment window. Providers in the control group will not receive alerts and will manage injections as per their clinic's standard process. Surveys will be administered to understand the utility of the alerts for the management of these injections.

Official Title
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Facilitating the Management of CAB+RPV LA Patient Visits Through Daily Alerts and Morning Huddles

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (patients): As per label, routine clinical care Inclusion Criteria (clinics): AIDS Healthcare Foundation (AHF) Clinic HIV primary care clinic Minimum of 100 people living with HIV in care with a viral load <50 copies/mL at the time of randomization (satellites will be included in the count of their parent clinic).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized trial. The clinics will be randomized to either start using the Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App (Intervention Arm) or to standard of care (Control Arm).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Clinics randomized to the intervention. A notification will be sent to the provider when a patient on CAB+RPV LA needs to be scheduled for their injections or when an appointment needs to be confirmed. Alerts are sent out to the provider when a patient is due or overdue for their injections. | Other: Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App<br>* The CHORUS App has been developed as a tool for clinicians to easily visualize important patient information from their smart phones. Relevant information is electronically distributed and placed within the corresponding module in the CHORUS HCP mobile app for iOS and Android.<br>|
| No Intervention: Control<br>Clinics randomized to the control group. No alerts or notification will be sent. The providers will manage their CAB+RPV LA patients using standard of care in their clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to treatment-window | Patient returns for their injections +/- 7 days from target date | 9 months | 
| Acceptability and usefulness of the intervention | Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App. | Month 1 | 
| Acceptability and usefulness of the intervention | Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App. | Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CAB+RPV LA patients managed through the app | Reach | 9 months | 
| Number of clinics that use the App for the management of CAB+RPV LA patients | Adoption | 9 month |