Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT07213258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-10-07', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Meth use', 'timeFrame': '6 months', 'description': 'Explored through monthly self-reported data on the CHAMPION App (intervention arm). We will calculate the following outcome:\n\n1\\) Days of meth use in the past month (mean, standard deviation)'}, {'measure': 'Sexual risk behavior', 'timeFrame': '6 months', 'description': 'To determine the preliminary efficacy in reducing sexual risk behaviors, we will use GEE Poisson, binomial and negative binomial models with robust standard errors to assess evidence that the intervention reduces HIV risk behaviors. We will calculate the following outcomes:\n\n1. number of sex partners (mean, standard deviation)\n2. number of sex partners with whom meth are used (mean, standard deviation)\n3. episodes of condomless sex with serodiscordant partners (mean, standard deviation)'}], 'primaryOutcomes': [{'measure': 'Feasibility & Acceptability of CHAMPION', 'timeFrame': '6 months', 'description': 'We will calculate the following feasibility and acceptability measures:\n\n1. study completion rate (mean, standard deviation)\n2. days of PrEPAPP use (mean, standard deviation)\n3. CBT4CBT virtual sessions completed (mean, standard deviation)'}, {'measure': 'PrEP adherence', 'timeFrame': '6-Months', 'description': 'We will examine the preliminary efficacy of CHAMPION vs. a waitlist control on increasing PrEP adherence, compared to a waitlist control as determined by dried blood spot (DBS) tests. In preparation for a larger efficacy trial, we will explore the preliminary efficacy of CHAMPION vs. waitlist control in increasing PrEP adherence. PrEP drug levels in DBS samples will be dichotomized as PrEP adherence, or not, using established cut-offs for protective levels of PrEP. We will calculate the following outcome measure:\n\n1.) Number and percent adherent to PrEP, based on DBS.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSM', 'HIV Negative', 'mild MUD', 'moderate MUD', 'Methamphetamine Use Disorder (MUD)', 'CBT4CBT', 'PrEPAPP', 'mHealth', 'Cognitive Behavioral Therapy'], 'conditions': ['PrEP Adherence', 'Methamphetamine Use Disorder', 'HIV']}, 'descriptionModule': {'briefSummary': "The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are:\n\n* To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates.\n* To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.", 'detailedDescription': 'The CHAMPION (Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM) study, a randomized controlled trial that aims to pilot test state-of-the-art multi-modal pharmaco-behavioral interventions to increase PrEP adherence among HIV-negative MSM who use meth, versus a waitlist control. The study will enroll 100 HIV-negative MSM with mild or moderate meth use disorder (MUD) and sub-optimal PrEP adherence. The study will follow participants for 6 months. The intervention arm will receive the 6-month mHealth intervention package, CHAMPION, at baseline, while the waitlist control will receive it at month-3 follow-up. Results of this pilot study will determine the viability of combining interventions that reduce meth use and enhance PrEP adherence, informing the direction of future interventions for MSM who use meth.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. HIV-negative\n2. Cis-gender male\n3. Age 18-40 years old\n4. Mild or moderate MUD (by DSM-5 SCID criteria)\n5. Anal intercourse with one or more male partners in the past 6 months\n6. Started daily oral PrEP more than 30 days ago and self-reported not always taking PrEP as prescribed in the past 30 days (consistent with PrEP It! inclusion criteria)\n7. Willingness to participate in an mHealth study with a 6-month follow-up\n8. Residing in San Diego or San Francisco County\n\nExclusion Criteria:\n\n1. Residing outside of San Diego or San Francisco County\n2. Any condition that, in the principal investigator's judgment interferes with safe study participation or adherence to study procedures\n3. Not able/willing to complete virtual/remote visits\n4. Not willing to learn to self-collect dried blood spots using a finger stick"}, 'identificationModule': {'nctId': 'NCT07213258', 'acronym': 'CHAMPION', 'briefTitle': 'CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM', 'orgStudyIdInfo': {'id': 'R21DA060856', 'link': 'https://reporter.nih.gov/quickSearch/R21DA060856', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21DA060856', 'link': 'https://reporter.nih.gov/quickSearch/R21DA060856', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHAMPION Intervention Arm', 'description': 'mHealth app to track and promote PrEP adherence using motivational messages combined with computer-administered cognitive behavioral therapy for the full 6-month period.', 'interventionNames': ['Behavioral: CHAMPION Intervention']}, {'type': 'OTHER', 'label': 'Waitlist Control Arm', 'description': '3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention.', 'interventionNames': ['Behavioral: Delayed CHAMPION Package']}], 'interventions': [{'name': 'CHAMPION Intervention', 'type': 'BEHAVIORAL', 'description': 'MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.', 'armGroupLabels': ['CHAMPION Intervention Arm']}, {'name': 'Delayed CHAMPION Package', 'type': 'BEHAVIORAL', 'description': 'Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.', 'armGroupLabels': ['Waitlist Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Glenn-Milo Santos', 'role': 'CONTACT'}], 'facility': 'Center on Substance Use and Health', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Glenn-Milo Santos, PhD, MPH', 'role': 'CONTACT', 'email': 'glenn-milo.santos@ucsf.edu', 'phone': '628-217-6231'}, {'name': 'Alexandrea Dunham, B.A.', 'role': 'CONTACT', 'email': 'allie.dunham@sfdph.org', 'phone': '530-925-3398'}], 'overallOfficials': [{'name': 'Glenn-Milo Santos, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Kiyomi Tsuyuki, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Multi-Principal Investigator', 'investigatorFullName': 'Kiyomi Tsuyuki', 'investigatorAffiliation': 'University of California, San Francisco'}}}}