Cabenuva Injection Tracking in CHORUS

NCT04863261 | Completed

• 1 other identifier: Pro00050130
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of CAB+RPV LA patients managed through the app

  9 months

• Number of clinics that use the App for the management of CAB+RPV LA patients

  9 month

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App OTHER

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• As per label, routine clinical care
• 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).

Sponsors & Collaborators

• Epividian: lead
• AIDS Healthcare Foundation: collaborator
• ViiV Healthcare: collaborator

Study Sites (1)

AIDS Healthcare Foundation

Los Angeles, California, 90028, United States

Location

Related Publications (1)

• Wohlfeiler MB, Brunet L, Cochran Q, Fusco JS, Hsu RK, Fusco GP. Improving Adherence to the Target Window for Cabotegravir + Rilpivirine Long-Acting Injections Through the CHORUS App and Web Portal: A Cluster Randomized Trial. J Int Assoc Provid AIDS Care. 2024 Jan-Dec;23:23259582241245223. doi: 10.1177/23259582241245223.

  PMID: 38613372 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Michael Wohlfeiler, MD

  AHF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: October 1, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: February 25, 2025

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)