Cabenuva Injection Tracking in CHORUS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-07-07

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No