Cabenuva Injection Tracking in CHORUS

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863261
• Other study ID #: Pro00050130
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: July 7, 2022

Study information

• Verified date: October 2021
• Source: Epividian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App
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.

Locations

Country	Name	City	State
United States	AIDS Healthcare Foundation	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Epividian	AIDS Healthcare Foundation, ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to treatment-window	Patient returns for their injections +/- 7 days from target date	9 months
Primary	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
Primary	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	Number of CAB+RPV LA patients managed through the app	Reach	9 months
Secondary	Number of clinics that use the App for the management of CAB+RPV LA patients	Adoption	9 month