Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT05352061
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-29
First Post:
2022-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076603', 'term': 'Syndemic'}], 'ancestors': [{'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who completes the follow up assessment', 'timeFrame': '8 months', 'description': 'Feasibility will be reported as the percentage of participants who completes the study follow up assessment.'}], 'secondaryOutcomes': [{'measure': 'ART Medication Adherence', 'timeFrame': 'Up to 8 months', 'description': 'Antiretroviral Therapy (ART) adherence will be reported as the percentage of participants who reports taking \\> 80% of their ART from baseline up to follow up visit.'}, {'measure': 'Percentage of participants with undetectable viral load', 'timeFrame': 'Up to 8 months', 'description': 'As assessed via serum blood samples.'}, {'measure': 'Percentage of participants with improvement in syndemic, behavioral health outcomes', 'timeFrame': 'Up to 8 months', 'description': 'Participants with a 2-point reduction in their Diagnostic Interview for Anxiety, Mood and Obsessive Compulsive Disorder (OCD) Related Neuropsychiatric Disorders (DIAMOND) scores from baseline will be reported as having improvement in behavioral health outcome. DIAMOND has a total score ranging from 1-7 with the higher score indicating greater severity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV Medication Adherence', 'Mental Health'], 'conditions': ['Medication Adherence', 'Mental Health Issue']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Three distinct groups will be recruited: 1) Men who have sex with men who use stimulants, 2) transgender women, 3) emerging adults (ages 18-26 years).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18 years or older\n2. HIV positive\n3. Evidence of uncontrolled virus (e.g., \\> 20 copies/ml) within the past 12 months as verified by medical record\n4. Group 1: (Men who have sex with men (MSM) who have used stimulants within the past 4 months (approximately 10 participants))OR Group 2: transgender women (approximately 10 participants) OR Group 3: Emerging adults between the ages of 18 and 26 (inclusive; approximately 10 participants)\n\nExclusion Criteria:\n\n1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview\n2. Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation\n3. Opinion of the PI that the participant would be at risk for harm to self or others\n4. Currently receiving CBT for a psychiatric disorder, or received a course of CBT in the past year.'}, 'identificationModule': {'nctId': 'NCT05352061', 'acronym': 'Synk2b', 'briefTitle': 'Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2b', 'orgStudyIdInfo': {'id': '20210836'}, 'secondaryIdInfos': [{'id': '9K24DA040489', 'link': 'https://reporter.nih.gov/quickSearch/9K24DA040489', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group', 'description': 'Participants in this group will receive the CBT for Syndemics and Adherence Factors intervention for a total of 14 sessions over 4 months.', 'interventionNames': ['Behavioral: CBT for Syndemics and Adherence Factors']}], 'interventions': [{'name': 'CBT for Syndemics and Adherence Factors', 'type': 'BEHAVIORAL', 'description': 'Each hour-long session is conducted via zoom or in person with a study clinician. Sessions focus on HIV medication adherence, coping with life stressors, and managing other challenging situations (e.g., possible traumatic experiences, drug and alcohol use and sexual behavior) that may affect mental or HIV-related health.', 'armGroupLabels': ['Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Steven A Safren, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steven Safren', 'investigatorAffiliation': 'University of Miami'}}}}