Cabenuva Injection Tracking in CHORUS

Epividian

Status: Completed

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04863261

Pro00050130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

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

Control

No Intervention group

Description:

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.