Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT02310893
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2014-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 579}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2014-07-18', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in retention-in-care behaviors over 12 months', 'timeFrame': 'Basline, follow-ups at month 2, 6, 12', 'description': 'Using a 2x2 factorial design, to examine the effect of the three interventions -- peer navigation, contingency management, combined approach and usual care -- and evaluate how well they improve retention in HIV care'}, {'measure': 'Change in HIV RNA viral load suppression and medication adherence over 12 months', 'timeFrame': 'Basline, follow-ups at month 2, and 12', 'description': 'Using the same design, to examine the effects of the PN, CM and, CA interventions on HIV RNA viral load suppression and self-reported adherence'}], 'secondaryOutcomes': [{'measure': 'Cost effectiveness', 'timeFrame': '5 years', 'description': 'A secondary aim is to examine the cost-offset and potential cost-effectiveness of each intervention compared with usual care'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV/AIDS']}, 'descriptionModule': {'briefSummary': "Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the health care provider, regular monitoring and regular delivery of medications, - known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low-income minorities are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA) which the investigators hypothesize to be most effective in improving HIV clinical outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed HIV+\n2. Age 18 years or older\n3. English or Spanish speaking\n4. Residence in Los Angeles County\n5. prescribed ART in prior 24 months\n6. \\< 3 visits in prior 12 months or have detectable viral load, as identified in the Ryan White CaseWatch database\n\nExclusion Criteria:\n\nNot meeting any of the criteria identified above'}, 'identificationModule': {'nctId': 'NCT02310893', 'acronym': 'CHAMPS', 'briefTitle': 'Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care', 'orgStudyIdInfo': {'id': '1R01MH103076-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH103076-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Contingency Management only', 'description': 'Participants assigned to this arm will receive payments for attending regular HIV medical appointments at the clinic and filling prescribed HIV medications at the pharmacy', 'interventionNames': ['Behavioral: Contingency Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Peer Navigation only', 'description': 'Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care', 'interventionNames': ['Behavioral: Peer Navigation']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Contingency Management and Peer Navigation', 'description': 'Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care and will be eligible to receive incentives for attending HIV care visits/refilling prescriptions.', 'interventionNames': ['Behavioral: Combined Contingency Management and Peer Navigation']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Participants in this arm will receive the care that they would usually get in their clinic in the absence of this study.'}], 'interventions': [{'name': 'Combined Contingency Management and Peer Navigation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Combined Contingency Management and Peer Navigation']}, {'name': 'Contingency Management', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Contingency Management only']}, {'name': 'Peer Navigation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Peer Navigation only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90012', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Center for Health Justice', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90012', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Los Angeles Sheriff's Department", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AltaMed Health Services Corporation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Oasis Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '91401', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Northeast Valley Health Corporation', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}], 'overallOfficials': [{'name': 'William Cunningham, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}