Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-01-07 @ 2:15 PM
Study NCT ID:
NCT05804461
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary', 'timeFrame': '150 days', 'description': 'PrEP uptake'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Prevention']}, 'descriptionModule': {'briefSummary': 'To develop, assess and compare the effectiveness of a Motivational Interviewing Intervention for increasing Pre-Exposure Prophylaxis (PrEP) uptake among Latino Men Who Have Sex With Men (MSM) in Puerto Rico.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Latino MSM group - Inclusion Criteria:\n\n* Biological male\n* Age 21 or older\n* Self-reported HIV negative or unknown status\n* Not using PrEP (participants who have discontinued PrEP use can participate in the study), Spanish fluency (ability to write and read in Spanish)\n* Presenting at least one of the eligibility criteria for PrEP as established by the CDC (including men who have had an infection (STI) in the past 6 months, HIV positive sexual partner)\n* Access to a portable technology device (e.g., phone, tablet, laptop) or desktop computer access to internet connection\n\nExclusion Criteria:\n\n* HIV positive individual\n* Evidence of being under the effects of alcohol or drugs\n* Indication of unstable or serious psychiatric symptoms\n* Evidence of major cognitive impairment\n* Inability to speak and read in Spanish\n\nHealthcare Providers group - Inclusion Criteria:\n\n* Age 21 or older\n* Providing PrEP related health services at time of enrollment (e.g., case management, clinical services)\n* Spanish fluency (ability to write and read in Spanish)\n\nExclusion Criteria:\n\n* Evidence of being under the effects of alcohol or drugs\n* Indication of unstable or serious psychiatric symptoms\n* Evidence of major cognitive impairment\n* Inability to speak and read in Spanish'}, 'identificationModule': {'nctId': 'NCT05804461', 'briefTitle': 'Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico', 'organization': {'class': 'OTHER', 'fullName': 'University of Puerto Rico'}, 'officialTitle': 'Optimizing PrEP Uptake Among Latino MSM in Puerto Rico: A Comparative Effectiveness Study', 'orgStudyIdInfo': {'id': '2290030276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Face-to-face intervention', 'description': 'A three-session face-to-face intervention using Motivational Interviewing with a facilitator; to increase Pre-Exposure Prophylaxis (PrEP) uptake. Pre-post-post evaluations after each session will be administered. Participation will last 150 days from the start to the last follow-up.', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'EXPERIMENTAL', 'label': 'Online intervention', 'description': 'A three-session online intervention using Motivational Interviewing with a facilitator; to increase Pre-Exposure Prophylaxis (PrEP) uptake. Pre-post-post evaluations after each session will be administered. Participation will last 150 days from the start to the last follow-up.', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention. Pre-post evaluations will be administered.'}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': "Upon refinement from Formative Research (Aim 1), a three-session, individual-level intervention to increase Pre-Exposure Prophylaxis (PrEP) uptake among men who have sex with men (MSM) in Puerto Rico will be implemented. The facilitator will use Motivational Interviewing techniques to guide the sessions. The intervention's design and content will be the same for each study group; the only difference will be the modality of implementation; one group of participants will receive a face-to-face intervention, while another group will receive an online intervention.A total of 170 participants will be randomized in a 1:1 ratio into each of the two intervention modalities (n=85 face-to-face and n=85 online) while a control group will be recruited following a 3:1 ratio of intervention vs. control. In addition to baseline assessment, participants will be asked to complete a post test at the end of the third session (60 days) and a follow-up post-test at the 150-day mark, separately.", 'armGroupLabels': ['Face-to-face intervention', 'Online intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00936', 'city': 'San Juan', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'name': 'Souhail M Malave Rivera, PhD', 'role': 'CONTACT', 'email': 'souhail.malave@upr.edu', 'phone': '787 758 2525', 'phoneExt': '4412'}], 'facility': 'University of Puerto Rico Medical Sciences Campus', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Puerto Rico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}