Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-29 @ 7:45 AM
Study NCT ID:
NCT06444360
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2024-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults (IMPACT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040242', 'term': 'Risk Reduction Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-03', 'size': 1759170, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-20T15:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study is a two-arm, multi-site, randomized controlled trial (RCT). IMPACT is a status-neutral intervention that uses behavioral activation (BA)-an evidence-based, cognitive behavior therapy-as a treatment for stimulant use and sexual risk reduction (RR) counseling for adolescents and young adults.\n\nThe IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on strategies for slip-ups and recurrence management.\n\nThe enhanced Standard of Care (eSOC) group includes two HIV sexual RR sessions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distinct acts of condomless sex without the protection of PrEP or viral suppression.', 'timeFrame': 'Participants will recall and report acts of condomless sex and medication adherence for the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12.', 'description': 'The number of times participants report engaging in condomless sex without the protection of PrEP (for those not living with HIV) or viral suppression (for those living with HIV).'}], 'secondaryOutcomes': [{'measure': 'Days of stimulant use', 'timeFrame': 'Participants will recall and report the number of days they used stimulants out of the 30 days prior to each of 4 visits and will also have urine drug testing done. The visits are at: Baseline, Month 4, Month 8 and Month 12.', 'description': 'The number of days participants report having used stimulants'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behavioral Activation', 'risk reduction', 'intervention', 'stimulant use', 'HIV sexual risk reduction'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.', 'detailedDescription': 'IMPACT is a Human Immunodeficiency Virus (HIV) status-neutral, behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk. This study will evaluate the effectiveness of IMPACT and determine feasibility of implementing IMPACT for translation into real-world practice using a hybrid effectiveness-implementation design.\n\nThe IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on strategies for slip-ups and recurrence management.\n\nThe enhanced Standard of Care (eSOC) group includes two HIV sexual RR sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16-24 years, inclusive, at enrollment\n* Male or female\n* Self-reports condomless anal or vaginal sex while using stimulants (5 hour prior to, or during sex) within the last 4 months; stimulants is defined as crystal methamphetamine, cocaine, and MDMA (e.g., ecstasy, molly)\n* Willing and able to provide written informed consent for study participation\n* Access to a computer/smartphone/tablet that can use video chat (e.g., Zoom or Google Meet)\n* Provide a mailing address where they can receive a package\n* Access to stable internet that they can use for more than 2 hours at a time\n* Have a private place (where no one else can see or hear) where they can complete visits online\n* Reside within the continental U.S.\n\nExclusion Criteria:\n\n* Unable to provide informed consent due to severe mental or physical illness\n* Concurrent enrollment in another HIV prevention or treatment study (enrollment in a substance treatment program is acceptable)\n* Randomized to IMPACT arm prior to March 2025 study stop\n* Non-English-speaking\n* Is currently incarcerated or pending incarceration\n* Is currently pregnant or planning to become pregnant\n* Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Project Lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results'}, 'identificationModule': {'nctId': 'NCT06444360', 'acronym': 'IMPACT', 'briefTitle': 'Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults (IMPACT)', 'organization': {'class': 'OTHER', 'fullName': 'Westat'}, 'officialTitle': 'Hybrid Type 2 Effectiveness-Implementation Trial of Status Neutral, Integrated Behavioral Activation and Risk Reduction Intervention for Stimulant Use Among Sexually Active Adolescents and Young Adults (Project IMPACT)', 'orgStudyIdInfo': {'id': 'ATN170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMPACT Group', 'description': 'Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention.', 'interventionNames': ['Behavioral: IMPACT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Standard of Care (eSOC) Group', 'description': 'Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with one-third being allocated to the eSOC intervention.', 'interventionNames': ['Behavioral: eSOC']}], 'interventions': [{'name': 'IMPACT', 'type': 'BEHAVIORAL', 'description': 'The IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling (including PrEP or ART and HIV care), and 1 final session on strategies for slip-ups and recurrence management.', 'armGroupLabels': ['IMPACT Group']}, {'name': 'eSOC', 'type': 'BEHAVIORAL', 'description': 'The eSOC group includes 2 sessions of HIV sexual RR counseling.', 'armGroupLabels': ['Enhanced Standard of Care (eSOC) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'IMPACT 170 Staff', 'role': 'CONTACT', 'email': 'impactstudy@ph.ucla.edu', 'phone': '310-825-3094'}, {'name': 'Matthew Mimiaga, ScD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'IMPACT 170 Staff', 'role': 'CONTACT', 'email': 'impact170@brown.edu', 'phone': '401-863-3292'}, {'name': 'Katie Biello, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Erin Ricketts', 'role': 'CONTACT', 'email': 'erinricketts@westat.com', 'phone': '240-453-2786'}], 'overallOfficials': [{'name': 'Katie Biello, PhD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Brown University'}, {'name': 'Matthew Mimiaga, ScD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westat', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}