Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-30 @ 12:08 AM
Study NCT ID:
NCT05949203
Status:
UNKNOWN
Last Update Posted:
2023-12-06
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oregon PrEP at Home Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584914', 'term': 'cabotegravir'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-07-15', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'On-time initiation and continuation doses', 'timeFrame': '24 months', 'description': 'Proportion of on-time initiation and continuation doses of CAB-LA administered'}], 'secondaryOutcomes': [{'measure': 'Successful home infusion pharmacy referrals', 'timeFrame': '24 months', 'description': 'Proportion of referrals to home infusion that result in successful CAB-LA initiation over the study period'}, {'measure': 'Time to initiation', 'timeFrame': '24 months', 'description': 'Time in days between first tele-PrEP appointment and administration of first CAB-LA dose'}, {'measure': 'Persistence rate', 'timeFrame': '24 months', 'description': 'The persistence rate of participation in the tele-PrEP/home infusion pharmacy program for administration of CAB-LA'}, {'measure': 'Sexually transmitted infection screenings', 'timeFrame': '24 months', 'description': 'Number of HIV, gonorrhea, chlamydia, and syphilis screenings per participant over 10 months of CAB-LA continuation'}, {'measure': 'Participant experience', 'timeFrame': '24 months', 'description': 'Assessment of TPP/HIP program for delivery of CAB-LA continuation therapy using a bespoke questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV prevention', 'PrEP', 'telemedicine', 'home infusion pharmacy', 'long-acting cabotegravir'], 'conditions': ['HIV/AIDS']}, 'descriptionModule': {'briefSummary': 'This demonstration study will evaluate the real-world implementation of long-acting cabotegravir (CAB-LA) for HIV pre-exposure prevention (PrEP) through a partnership between the OHSU Tele-PrEP Program (TPP) and the OHSU Home Infusion Pharmacy (HIP). The study will perform a formative evaluation of the TPP/HIP partnership to determine its merit and worth, with revisions made as needed to improve the program, which is reflective of a real-world program rollout. The study is observational, and there is no comparison group. The primary objective is to evaluate adherence to CAB-LA by both urban and rural participants using the TPP/HIP partnership. The goals of the study are improve the TPP/HIP program itself with attention to reducing geographic disparities, and to disseminate best practices and lessons learned to the broader HIV prevention community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Oregon age 18 or older who are eligible for HIV pre-exposure prophylaxis with long-acting cabotegravir through the OHSU Tele-PrEP Program and OHSU Home Infusion Pharmacy. People of childbearing potential or who are breast/chest feeding are eligible, but pregnant people are ineligible.', 'genderDescription': 'All genders are eligible', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Residence in Oregon\n* English or Spanish spoken and written language ability\n* Clinical eligibility for PrEP with CAB-LA including HIV-negative serostatus\n* Access to stable Internet\n* Access to a clean, safe location that is appropriate for home administration\n\nExclusion Criteria:\n\n* Clinical ineligibility for PrEP with CAB-LA including HIV-positive serostatus, injection drug use as only HIV risk factor, or clinical contraindication (such as a hypersensitivity reaction to CAB-LA or use of a contraindicated medication).\n* Uninsured\n* Payer does not cover HIP services\n* Pregnancy\n* Residence outside of the home infusion program's catchment area\n* Incarceration\n* Decisional impairment"}, 'identificationModule': {'nctId': 'NCT05949203', 'acronym': 'OR-PrEP@Home', 'briefTitle': 'Oregon PrEP at Home Study', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Oregon PrEP at Home Study: Real-world Delivery of Long-acting Cabotegravir (CAB-LA) for HIV Pre-exposure Prophylaxis (PrEP) Through a Tele-PrEP Program and a Home Infusion Program Partnership to Address Geographic PrEP Disparities in Oregon', 'orgStudyIdInfo': {'id': 'STUDY00025207'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': 'All participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy.', 'interventionNames': ['Drug: Cabotegravir Injection']}], 'interventions': [{'name': 'Cabotegravir Injection', 'type': 'DRUG', 'otherNames': ['Apretude'], 'description': 'Administration of HIV pre-exposure prophylaxis with cabotegravir 600 mg/3mL extended release injectable suspension every other month.', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher B Fox, MSN', 'role': 'CONTACT', 'email': 'prepstudy@ohsu.edu', 'phone': '833-770-1400'}, {'name': 'Christopher D Evans, MD, MPH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Christopher B Fox, MSN', 'role': 'CONTACT', 'email': 'prepstudy@ohsu.edu', 'phone': '833-770-1400'}], 'overallOfficials': [{'name': 'Christopher B Fox, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified individual participant data and adverse event reporting will be shared with the study partner ViiV Healthcare.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}