Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 10:42 PM
Study NCT ID:
NCT04863261
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2021-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabenuva Injection Tracking in CHORUS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to treatment-window', 'timeFrame': '9 months', 'description': 'Patient returns for their injections +/- 7 days from target date'}, {'measure': 'Acceptability and usefulness of the intervention', 'timeFrame': 'Month 1', 'description': 'Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \\& Huddle modules of the CHORUS App.'}, {'measure': 'Acceptability and usefulness of the intervention', 'timeFrame': 'Month 9', 'description': 'Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \\& Huddle modules of the CHORUS App.'}], 'secondaryOutcomes': [{'measure': 'Number of CAB+RPV LA patients managed through the app', 'timeFrame': '9 months', 'description': 'Reach'}, {'measure': 'Number of clinics that use the App for the management of CAB+RPV LA patients', 'timeFrame': '9 month', 'description': 'Adoption'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '38613372', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (patients):\n\n* As per label, routine clinical care\n\nInclusion Criteria (clinics):\n\n* AIDS Healthcare Foundation (AHF) Clinic\n* HIV primary care clinic\n* 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).'}, 'identificationModule': {'nctId': 'NCT04863261', 'briefTitle': 'Cabenuva Injection Tracking in CHORUS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epividian'}, 'officialTitle': 'Facilitating the Management of CAB+RPV LA Patient Visits Through Daily Alerts and Morning Huddles', 'orgStudyIdInfo': {'id': 'Pro00050130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', '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.', 'interventionNames': ['Other: Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App']}, {'type': 'NO_INTERVENTION', 'label': 'Control', '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.'}], 'interventions': [{'name': 'Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Michael Wohlfeiler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AHF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epividian', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AIDS Healthcare Foundation', 'class': 'OTHER'}, {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}