Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AIDS Healthcare Foundation | OTHER |
| ViiV Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of CAB+RPV LA patients managed through the app | Reach | 9 months |
| Number of clinics that use the App for the management of CAB+RPV LA patients | Adoption |
Not provided
Inclusion Criteria (patients):
Inclusion Criteria (clinics):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Wohlfeiler, MD | AHF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDS Healthcare Foundation | Los Angeles | California | 90028 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38613372 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
|
| 9 month |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |