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OpenTrials
Completed

NCT Number: NCT04863261

Cabenuva Injection Tracking in CHORUS

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Adherence to treatment-window

    Time frame: 9 months

    Patient returns for their injections +/- 7 days from target date

  2. Acceptability and usefulness of the intervention

    Time frame: Month 1

    Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App.

  3. Acceptability and usefulness of the intervention

    Time frame: Month 9

    Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App.

Secondary outcomes

  1. Number of CAB+RPV LA patients managed through the app

    Time frame: 9 months

    Reach

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

    Time frame: 9 month

    Adoption

Sponsors and collaborators

Lead sponsor

Epividian

Industry

Collaborators

  • AIDS Healthcare Foundation
  • ViiV Healthcare

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2021
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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