Cabenuva Injection Tracking in CHORUS

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Other: Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App

• Registration Number: NCT04863261
• Lead Sponsor: Epividian

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.

Study Timeline

• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-28
• Status Verified: 2021-10
• Study Start: 2021-10-01
• Primary Completion: 2022-07-07
• Study Completion: 2022-07-07
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of CAB+RPV LA patients managed through the app	9 months	Reach
Number of clinics that use the App for the management of CAB+RPV LA patients	9 month	Adoption

Trial Locations

Locations (1)

AIDS Healthcare Foundation; 🇺🇸 Los Angeles, California, United States