HIV Infections
Conditions
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.
Detailed 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.
Interventions
OTHERCabenuva 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.
Sponsors
AIDS Healthcare Foundation
ViiV Healthcare
Epividian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to treatment-window | 9 months | Patient returns for their injections +/- 7 days from target date |
| Acceptability and usefulness of the intervention | Month 1 | Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of CAB+RPV LA patients managed through the app | 9 months | Reach |
| Number of clinics that use the App for the management of CAB+RPV LA patients | 9 month | Adoption |
Countries
United States
Outcome results
None listed