Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-01 @ 10:07 PM
Study NCT ID:
NCT05424718
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2022-06-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MyPEEPS Mobile for Young Transgender Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rb897@columbia.edu', 'phone': '212-342-6886', 'title': 'Rebecca Schnall, PhD, MPH, RN-BC, FAAN, FACMI', 'organization': 'Columbia University'}, 'certainAgreement': {'otherDetails': 'Any presentation, abstract, or manuscript will be made available for review by the study sponsor(s) prior to submission', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Condomless Receptive Sex Acts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'OG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}], 'classes': [{'title': 'Baseline and 3 Months', 'categories': [{'measurements': [{'value': '1.57', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '9.75', 'groupId': 'OG001'}]}]}, {'title': '3 Months and 6 Months', 'categories': [{'measurements': [{'value': '1.43', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '17.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Change in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth', 'unitOfMeasure': 'Condomless Receptive Sex Acts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'OG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}], 'classes': [{'title': '3 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 6 months', 'description': 'Number of participants that self-reported nPEP use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Pre-exposure Prophylaxis (PrEP) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'OG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}], 'classes': [{'title': '3 Months', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 6 months', 'description': 'Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'OG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}], 'classes': [{'title': '3 Months', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 6 months', 'description': 'Number of participants that self-reported HIV testing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Sexually Transmitted Infections (STI) Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'OG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}], 'classes': [{'title': '3 Months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 6 months', 'description': 'Number of participants that self-reported STI Testing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Partner PrEP Use and Adherence or Viral Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'OG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}], 'timeFrame': 'Baseline, 3 and 6 months', 'description': "Change in participant's self-report of their partner(s) PrEP use and adherence or viral suppression (if partner(s) is HIV+)", 'reportingStatus': 'POSTED', 'populationDescription': "Data was not analyzed as participant's self-report of partner(s) PrEP use and adherence/viral supression data were not collected (due to unintentional omision of partner related questions in the participant questionnaire)."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'FG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'BG001', 'title': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.\n\nMyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '22.2', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '22', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Transgender Man', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Non-binary', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Self-Reported Nonoccupational Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (nPEP) Use', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The number of participants that self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) use.', 'unitOfMeasure': 'participants'}, {'title': 'Self-reported Pre-exposure Prophylaxis (PrEP) Use', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use', 'unitOfMeasure': 'Participants'}, {'title': 'Self-reported HIV Testing', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants that self-reported HIV testing', 'unitOfMeasure': 'Participants'}, {'title': 'Self-reported Sexually Transmitted Infection (STI) Testing', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants that self-reported STI testing', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-09', 'size': 1202648, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-19T10:24', 'hasProtocol': True}, {'date': '2023-07-24', 'size': 120523, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-19T10:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The intervention arm receives the intervention from baseline to 3 months and at the 3 month visit, access to the intervention is removed and the control/ delayed intervention arm then receives the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2022-06-15', 'resultsFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-19', 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Condomless Receptive Sex Acts', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Change in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth'}], 'secondaryOutcomes': [{'measure': 'Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use', 'timeFrame': '3 and 6 months', 'description': 'Number of participants that self-reported nPEP use'}, {'measure': 'Self-reported Pre-exposure Prophylaxis (PrEP) Use', 'timeFrame': '3 and 6 months', 'description': 'Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use'}, {'measure': 'Self-reported HIV Testing', 'timeFrame': '3 and 6 months', 'description': 'Number of participants that self-reported HIV testing'}, {'measure': 'Self-reported Sexually Transmitted Infections (STI) Testing', 'timeFrame': '3 and 6 months', 'description': 'Number of participants that self-reported STI Testing'}, {'measure': 'Change in Partner PrEP Use and Adherence or Viral Suppression', 'timeFrame': 'Baseline, 3 and 6 months', 'description': "Change in participant's self-report of their partner(s) PrEP use and adherence or viral suppression (if partner(s) is HIV+)"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MyPEEPS', 'Mobile Intervention', 'Human Immunodeficiency Virus (HIV)', 'Transgender Youth'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population.', 'detailedDescription': "Transgender youth in the United States have unique health needs but often face barriers to accessing and receiving health care services which contribute to disparate health outcomes including high vulnerability to HIV and other sexually transmitted infections. Emerging evidence has begun to document HIV-related sexual risk among young transgender men (YTM), as well as low uptake of pre-exposure prophylaxis among those with indications, suggesting high vulnerability to HIV infection. Despite the high prevalence and increased risk of HIV in YTM who have sex with cisgender men, only one prior HIV prevention intervention has been developed to address the specific sexual health needs of YTM, which indicates a critical gap in HIV prevention science. In response to this need, and building off preliminary work, the investigators propose to develop a mobile intervention for YTM building on MyPEEPS Mobile, which was originally developed for very young sexual minority men. Central to this intervention is the premise that it will be delivered to youth during a developmental period that precedes or coincides with sexual debut, an important time for intervention, prior to or concurrent with initiation of high-risk behaviors.\n\nGiven both the gap in HIV prevention science and the lack of current targeted interventions, and building upon our multidisciplinary team's extensive experience in HIV prevention, mobile health (mHealth), behavioral interventions, randomized controlled trials, and transgender health, the investigators propose the following specific aims: 1) Using qualitative methodology, expert feedback, and usability assessments, develop MyPEEPS Mobile for YTM, 2) Conduct a pilot randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the revised MyPEEPS Mobile App in a sample of 80 YTM (15-25 years) and refine the study methods for a future efficacy trial, and 3) Assess predisposing, enabling, and reinforcing factors for MyPEEPS Mobile among YTM through theoretically-guided in depth interviews. The proposed MyPEEPS intervention for YTM will be the first study to develop and pilot a scaled-up, mobile HIV prevention intervention designed by, and piloted for, a diverse group of YTM. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Identify as a transgender man or along the transmasculine spectrum (including a transmasculine non-binary gender; e.g., male, trans male, transmasculine gender non-binary);', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo participate in any aspect of the study, participants must be:\n\n* Between 15 and 25 years of age;\n* Female sex assigned at birth;\n* Identify as a transgender man or along the transmasculine spectrum (including a transmasculine non-binary gender; e.g., male, trans male, transmasculine gender non-binary);\n* Understand and read English;\n* Live within the US;\n* Own a smartphone;\n* Self-report condomless receptive anal or vaginal penile sex with either a cisgender male or transgender woman (e.g., individual designated or assigned male at birth) in the past year; and\n* Self-report HIV-negative or unknown status.\n\nExclusion Criteria:\n\nYouth are ineligible to participate in the trial if:\n\n* HIV positive;\n* Unable to provide informed consent due to severe mental or physical illness or substance intoxication at the time of enrollment;\n* Concurrently enrolled in another HIV prevention study.'}, 'identificationModule': {'nctId': 'NCT05424718', 'briefTitle': 'MyPEEPS Mobile for Young Transgender Men', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'MyPEEPS (Male Youth Pursuing Empowerment, Education, and Prevention Around Sexuality) Mobile for Young Transgender Men', 'orgStudyIdInfo': {'id': 'AAAT8624'}, 'secondaryIdInfos': [{'id': 'R34MH128163', 'link': 'https://reporter.nih.gov/quickSearch/R34MH128163', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Intervention', 'description': 'Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.', 'interventionNames': ['Behavioral: MyPEEPS Mobile']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Intervention', 'description': 'Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.', 'interventionNames': ['Behavioral: MyPEEPS Mobile']}], 'interventions': [{'name': 'MyPEEPS Mobile', 'type': 'BEHAVIORAL', 'description': 'Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).', 'armGroupLabels': ['Delayed Intervention', 'Immediate Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Callen-Lorde Community Health Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Rebecca Schnall, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'While individual participant data (IPD) will not be shared, the results of the study will be shared at conferences such as the American Public Health Association annual meeting and Infectious Disease week; provide organizations that are influential in HIV public health practice (e.g., International AIDS Society) with an executive summary, press releases, and/or published papers; publish results in peer-reviewed academic journals; provide a lay summary for participants and community partners.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, {'name': 'Callen-Lorde Community Health Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion', 'investigatorFullName': 'Rebecca Schnall, RN, MPH, PhD', 'investigatorAffiliation': 'Columbia University'}}}}