Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT03116932
Status:
UNKNOWN
Last Update Posted:
2018-04-05
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A
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': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Dried Blood Spots are obtained at 2 time points for participants in part B in order to assess adequate drug levels are retained for bulk shipping for processing at collaborating lab.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP acceptability using a PrEP knowledge and acceptability questionnaire.', 'timeFrame': 'One visit', 'description': 'Measure the degree of acceptance of PrEP in the study subjects'}, {'measure': 'PrEP knowledge using a PrEP knowledge and acceptability questionnaire.', 'timeFrame': 'One visit', 'description': 'Measure the level of education of the study subjects in the topic of PrEP using a questionnaire.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV prevention, high risk MSM, PrEP'], 'conditions': ['HIV/AIDS']}, 'descriptionModule': {'briefSummary': 'The target population for this project will be men-who-have-sex-with-men (MSM) at high risk of HIV acquisition', 'detailedDescription': '225 high risk MSM will be interviewed to understand the knowledge and acceptability of pre-exposure prophylaxis (PrEP) in this population in Puerto Rico. A 187 item questionnaire will administered which will evaluate socio-demographic information, sexual conducts, PrEP knowledge and PrEP acceptability.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '225 high risk men who have sex with men, HIV- subjects, 21 years or older , will be enrolled in Part A', 'genderDescription': 'Male-to-female transgender subjects are eligible for enrollment', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA;\n\nStudy subjects who meet the following inclusion criteria will be considered for enrollment for Part A:\n\n1. age 21 years or older\n2. understand and sign the informed consent form and willing to participate in the study\n3. male or transgender female\n4. has one of the following risk factors:\n\n * a high risk MSM as defined by:\n * having unprotected sexual intercourse with at least two male partners in the past 6 months, or\n * diagnosed with an STI in the past 6 months.\n\nPART A - EXCLUSION CRITERIA:\n\nSubjects with any of the following will not be considered for enrollment in Part A:\n\n1. Age younger than 21 years old\n2. Unable or unwilling to provide an informed consent\n3. Female gender at birth\n4. Do not meet the high risk criteria'}, 'identificationModule': {'nctId': 'NCT03116932', 'briefTitle': 'Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A', 'organization': {'class': 'OTHER', 'fullName': 'Puerto Rico Community Network for Clinical Research on AIDS'}, 'officialTitle': 'Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A', 'orgStudyIdInfo': {'id': 'Puerto Rico PrEP Study-Part A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Part A - high risk MSM', 'description': 'Part A will consist of a descriptive analysis of the acceptability and knowledge on the topic of PrEP of the individuals that undergo routine HIV testing and counseling in study facilities or through outreach activities.\n\nPart A will be focused only on high risk MSM. For this part of the study, 225 high risk will be interviewed to understand the knowledge and acceptability of PrEP in this population in Puerto Rico.', 'interventionNames': ['Behavioral: PrEP knowledge and acceptability questionnaire']}], 'interventions': [{'name': 'PrEP knowledge and acceptability questionnaire', 'type': 'BEHAVIORAL', 'description': 'This questionnaire consists of 187 items and evaluates socio-demographic variables, sex conducts, PrEP knowledge and PrEP acceptability.', 'armGroupLabels': ['Part A - high risk MSM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00928', 'city': 'San Juan', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Vivian Tamayo-Agrait, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '787-753-9443'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puerto Rico Community Network for Clinical Research on AIDS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vivian Tamayo-Agrait, MD', 'investigatorAffiliation': 'Puerto Rico Community Network for Clinical Research on AIDS'}}}}