Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-04-27 @ 1:51 PM
Study NCT ID:
NCT02037594
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2014-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
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': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 438}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP Uptake', 'timeFrame': 'BL through 3-months', 'description': 'Whether or not the patient decides to take PrEP'}, {'measure': 'PrEP Persistence', 'timeFrame': 'BL through 12-months', 'description': 'Whether or not patients who decide to take PrEP persist with the medication for the duration of the study.'}, {'measure': 'PrEP Adherence', 'timeFrame': 'BL through 12 months', 'description': 'Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.'}, {'measure': 'Sexual Risk Behavior', 'timeFrame': 'BL through 12-months', 'description': 'Measured through STI testing and self-report.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Pre-exposure prophylaxis', 'PrEP', 'MSM', 'Demonstration Project'], 'conditions': ['Human Immunodeficiency Virus (HIV)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cunyhart.org/spark', 'label': 'Study Website'}]}, 'descriptionModule': {'briefSummary': 'This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among men who have sex with men (MSM), and collaborates with a community health center to evaluate a two-stage intervention to improve PrEP decision-making, as well as persistence and adherence for those who chose to take PrEP.', 'detailedDescription': 'Pre-exposure prophylaxis (PrEP) refers to daily or intermittent oral administration of antiretroviral drugs designed to protect high-risk HIV-negative individuals from infection. In order for PrEP to become an effective prevention tool, three critical factors must be addressed: a) acceptability, i.e., individuals who would benefit from PrEP must know about it and be willing to take it; b) adherence, i.e., individuals who choose to PrEP as a prevention strategy must take the pills as prescribed; and c) implementation, i.e., processes and protocols must be developed to allow for the integration of PrEP delivery and programs into real world settings in a way that is feasible, scalable, and realistic. This project has three specific aims: 1) Identifying social and behavioral factors that are likely to influence PrEP implementation, acceptance, and use/adherence by men who have sex with men (MSM) in NYC, including factors at individual-, community-, and organizational-levels; 2) Examining social and behavioral factors associated with disparities in access to prevention and care services among MSM in NYC that might directly impact PrEP implementation programs and policies; and 3) Evaluating an intervention in which PrEP is introduced, provided, and supported as part of a prevention package delivered in an community health center. The project has the potential to exert a sustained and powerful influence not only on the effectiveness of PrEP interventions for MSM, but also on dissemination and scalability of a targeted intervention within community-based settings and in a manner that reduces disparities in access and maximizes cultural competence and acceptability.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registered patient receiving medical or health services at Callen-Lorde Community Health Center\n* Male sex (at birth) and reported sex with men or transwomen\n* At least 18 years of age\n* HIV-negative\n* At risk for HIV acquisition\n\nExclusion Criteria:\n\n* Past history of PrEP use or currently taking PrEP'}, 'identificationModule': {'nctId': 'NCT02037594', 'acronym': 'SPARK', 'briefTitle': 'Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting', 'organization': {'class': 'OTHER', 'fullName': 'Hunter College of City University of New York'}, 'officialTitle': 'Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting', 'orgStudyIdInfo': {'id': '349555-6'}, 'secondaryIdInfos': [{'id': 'R01AA022067', 'link': 'https://reporter.nih.gov/quickSearch/R01AA022067', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Counseling + SOC Adherence', 'description': 'Sexual Health Counseling followed by Standard of Care Adherence Support', 'interventionNames': ['Behavioral: Sexual Health Counseling', 'Behavioral: Standard of Care Adherence Support (Active Control)']}, {'type': 'EXPERIMENTAL', 'label': 'Counseling + Enhanced Adherence', 'description': 'Sexual Health Counseling followed by Enhanced Adherence Intervention', 'interventionNames': ['Behavioral: Sexual Health Counseling', 'Behavioral: Enhanced Adherence Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Information + SOC Adherence', 'description': 'PrEP Information followed by Standard of Care Adherence Support', 'interventionNames': ['Behavioral: PrEP Information (Active Control)', 'Behavioral: Standard of Care Adherence Support (Active Control)']}, {'type': 'EXPERIMENTAL', 'label': 'Information + Enhanced Adherence', 'description': 'PrEP Information followed by Enhanced Adherence Intervention', 'interventionNames': ['Behavioral: Enhanced Adherence Intervention', 'Behavioral: PrEP Information (Active Control)']}], 'interventions': [{'name': 'Sexual Health Counseling', 'type': 'BEHAVIORAL', 'description': "This brief intervention presents PrEP within the context of a patient's comprehensive sexual health plan and is designed to enhance decision-making around PrEP use and decrease sexual risk taking.", 'armGroupLabels': ['Counseling + Enhanced Adherence', 'Counseling + SOC Adherence']}, {'name': 'Enhanced Adherence Intervention', 'type': 'BEHAVIORAL', 'description': 'This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.', 'armGroupLabels': ['Counseling + Enhanced Adherence', 'Information + Enhanced Adherence']}, {'name': 'PrEP Information (Active Control)', 'type': 'BEHAVIORAL', 'description': 'Standard of Care Information about PrEP', 'armGroupLabels': ['Information + Enhanced Adherence', 'Information + SOC Adherence']}, {'name': 'Standard of Care Adherence Support (Active Control)', 'type': 'BEHAVIORAL', 'description': 'Standard of care information and instruction about PrEP adherence.', 'armGroupLabels': ['Counseling + SOC Adherence', 'Information + SOC Adherence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Callen-Lorde Community Health Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sarit A Golub, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunter College, CUNY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunter College of City University of New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sarit Golub', 'investigatorAffiliation': 'Hunter College of City University of New York'}}}}