Cabenuva Injection Tracking in CHORUS
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App
Sponsored by

About this trial
This is an interventional health services research trial for HIV Infections
Eligibility Criteria
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).
Sites / Locations
- AIDS Healthcare Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Adherence to treatment-window
Patient returns for their injections +/- 7 days from target date
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.
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.
Secondary Outcome Measures
Number of CAB+RPV LA patients managed through the app
Reach
Number of clinics that use the App for the management of CAB+RPV LA patients
Adoption
Full Information
NCT ID
NCT04863261
First Posted
April 23, 2021
Last Updated
February 14, 2023
Sponsor
Epividian
Collaborators
AIDS Healthcare Foundation, ViiV Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT04863261
Brief Title
Cabenuva Injection Tracking in CHORUS
Official Title
Facilitating the Management of CAB+RPV LA Patient Visits Through Daily Alerts and Morning Huddles
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
July 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epividian
Collaborators
AIDS Healthcare Foundation, ViiV Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to treatment-window
Description
Patient returns for their injections +/- 7 days from target date
Time Frame
9 months
Title
Acceptability and usefulness of the intervention
Description
Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App.
Time Frame
Month 1
Title
Acceptability and usefulness of the intervention
Description
Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App.
Time Frame
Month 9
Secondary Outcome Measure Information:
Title
Number of CAB+RPV LA patients managed through the app
Description
Reach
Time Frame
9 months
Title
Number of clinics that use the App for the management of CAB+RPV LA patients
Description
Adoption
Time Frame
9 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wohlfeiler, MD
Organizational Affiliation
AHF
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cabenuva Injection Tracking in CHORUS
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