Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-01 @ 9:00 PM
Study NCT ID:
NCT06741618
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2024-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2024-12-15', 'studyFirstSubmitQcDate': '2024-12-15', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP Initiation:', 'timeFrame': 'Baseline, 6-month follow-up, 12-month follow-up', 'description': 'Participants will self-report attending at least one PrEP-related care visit to asess medical eligibility for PrEP initiation.'}], 'secondaryOutcomes': [{'measure': 'PrEP Adherence', 'timeFrame': 'Baseline, 6-month follow-up, 12-month follow-up', 'description': 'Daily oral PrEP users will report PrEP use in the past 7-days.'}, {'measure': 'PrEP Persistence', 'timeFrame': 'Baseline, 6-month follow-up, 12-month follow-up', 'description': 'Questions will be measure visit constancy, i.e., self-report at least 1 PrEP related care visit in the past 6 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'care navigation'], 'conditions': ['HIV/AIDS']}, 'descriptionModule': {'briefSummary': 'MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.', 'detailedDescription': "This study expands MyPEEPS Mobile to develop MyPEEPS Mobile Plus, a multi-level intervention comprised of MyPEEPS Mobile with added PrEP content (based upon expert advisory and youth feedback) + PrEP E-Peer Navigation to overcome the challenges of PrEP initiation, adherence, and persistence among YMSM. Peer navigation is an evidence-based, widely recommended intervention for reaching youth and MSM for HIV-related care outcomes, with evidence of acceptability among racial/ethnic minority YMSM for PrEP. Peer navigation addresses common reasons for failing to begin or maintain PrEP use, including low perceived risk, structural or logistic barriers to care engagement, and anticipated side effects. Relative to in-person and group-based HIV prevention programs, behavioral interventions with digital and virtual components can have vast reach and present unique potential to rapidly scale delivery to very large and hidden groups. Therefore, the investigators propose to conduct a randomized controlled trial to test the efficacy of MyPEEPS Mobile Plus (a multi-level intervention comprised of MyPEEPS Mobile + PrEP E-Peer Navigation) for promoting initiation, adherence, and persistence of PrEP and decreased HIV risk behavior in YMSM. Building upon the team's demonstrated ability to enroll large numbers of young racially and ethnically diverse YMSM and extensive experience developing mobile health interventions, the proposed study will test the efficacy of this expanded, multi-level mobile HIV prevention intervention emphasizing PrEP. If efficacious, it will increase PrEP initiation, adherence, and persistence and decrease overall HIV risk in diverse YMSM in the US."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'genderBased': True, 'genderDescription': 'male, nonbinary, genderqueer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 16-25 years of age\n* identify as male, non-binary, or genderqueer\n* male sex assigned at birth\n* understand and read English\n* own a smartphone\n* report condomless anal sex with a male in the past year\n* HIV-negative (OraQuick verified)\n\nExclusion Criteria:\n\n* HIV Positive\n* If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol\n* Transgender identity\n* currently report consistent use of PrEP'}, 'identificationModule': {'nctId': 'NCT06741618', 'briefTitle': 'MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'MyPEEPS Mobile Plus', 'orgStudyIdInfo': {'id': 'AAAU8894'}, 'secondaryIdInfos': [{'id': 'R01MD019181', 'link': 'https://reporter.nih.gov/quickSearch/R01MD019181', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "Participants randomized to the control arm will receive standard of care information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP, referrals to the local PrEP clinic, and referrals for local sexually transmitted disease testing, and will have access to the MyPEEPS Mobile App during the study.", 'interventionNames': ['Behavioral: MyPEEPS Mobile']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants randomized to the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation for the entire 12-month study period.', 'interventionNames': ['Behavioral: MyPEEPS Mobile', 'Behavioral: Electronic PrEP peer navigation']}], 'interventions': [{'name': 'MyPEEPS Mobile', 'type': 'BEHAVIORAL', 'description': 'An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Electronic PrEP peer navigation', 'type': 'BEHAVIORAL', 'description': 'Electronic peer navigation to PreP services', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Schnall', 'role': 'CONTACT', 'email': 'rb897@cumc.columbia.edu', 'phone': '212-342-6886'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Rebecca Schnall, PhD, MPH', 'role': 'CONTACT', 'email': 'rb897@columbia.edu', 'phone': '212-342-6886'}], 'overallOfficials': [{'name': 'Robert Garofalo, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}, {'name': 'Lisa Kuhns, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, {'name': 'Callen-Lorde Community Health Center', 'class': 'OTHER'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion', 'investigatorFullName': 'Rebecca Schnall, RN, MPH, PhD', 'investigatorAffiliation': 'Columbia University'}}}}