Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-24 @ 7:49 PM
Study NCT ID:
NCT06586151
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2024-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Gender-inclusive HIV Prevention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants, but not researchers, will be blinded to study assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number testing for HIV and/or sexual transmitted infections', 'timeFrame': 'At any time after baseline through 8-months.', 'description': 'Self report of having been tested for either HIV or a sexually transmitted infection'}], 'secondaryOutcomes': [{'measure': 'Number Taking PreExposure Prophylaxis (PrEP) for HIV', 'timeFrame': 'At any time after baseline through 8-months.', 'description': 'Self-report of taking PrEP at any time since the prior assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Adolescence', 'mHealth'], 'conditions': ['HIV Prevention']}, 'descriptionModule': {'briefSummary': 'If, over time, data suggest the intervention impacts HIV preventive behavior at the population level, it will be unique in that it can be quickly and cost effectively scaled up to impact thousands of trans girls and nonbinary youth assigned male at birth.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'genderBased': True, 'genderDescription': 'Transgender girls and non-binary youth; not exclusively cisgender identified', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. assigned male sex at birth and currently have a non-cisgender identity (e.g., transgender girl, non-binary, gender fluid, unsure);\n2. aged 14-18 years and have not yet graduated high school;\n3. English-speaking;\n4. the sole user of a cell phone with an unlimited text messaging plan;\n5. have access to the Internet to complete online surveys;\n6. intend to have the same cell number for the next 6 months;\n7. provide informed assent;\n8. not have taken part in a previous #TranscendentHealth study activity or know someone who is in the study to increase the diversity of input from transgirls, and\n9. agree to enroll over the phone with study staff.\n\nExclusion Criteria:\n\n* None beyond not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06586151', 'briefTitle': 'Testing a Gender-inclusive HIV Prevention Program', 'organization': {'class': 'OTHER', 'fullName': 'Center for Innovative Public Health Research'}, 'officialTitle': 'Harnessing the Power of Technology to Develop a Population-based HIV Prevention Program for Trans Girls', 'orgStudyIdInfo': {'id': 'R01NR020309', 'link': 'https://reporter.nih.gov/quickSearch/R01NR020309', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Information, Motivation and Skills arm', 'description': "Text messaging-based program that lasts 5 months. Content includes information, motivation and behavioral skills about how to prevent HIV, as well as information about healthy and unhealthy romantic relationships, and navigating issues related to one's gender.", 'interventionNames': ['Behavioral: Transcendent Health']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Information Only arm', 'description': 'Text messaging-based program that lasts 5 months. Content includes information about HIV prevention and aspects of a healthy adolescent lifestyle (e.g., self-esteem).', 'interventionNames': ['Behavioral: Text Messaging with Information']}], 'interventions': [{'name': 'Transcendent Health', 'type': 'BEHAVIORAL', 'description': 'Gender-inclusive HIV prevention program: Text messaging-based program that lasts 5 months. Content includes information, motivation and behavioral skills about how to prevent HIV, as well as information about healthy and unhealthy romantic relationships, and navigating issues related to one\\'s gender.', 'armGroupLabels': ['Information, Motivation and Skills arm']}, {'name': 'Text Messaging with Information', 'type': 'BEHAVIORAL', 'description': 'Text messaging-based program that lasts 5 months. Content includes information about HIV prevention and aspects of a healthy adolescent lifestyle (e.g., self-esteem).', 'armGroupLabels': ['Information Only arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92672-6745', 'city': 'San Clemente', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michele L Ybarra, MPH PhD', 'role': 'CONTACT', 'email': 'Michele@InnovativePublicHealth.org', 'phone': '877-302-6858', 'phoneExt': '801'}, {'name': 'Michele L Ybarra, MPH PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Innovative Public Health Research', 'geoPoint': {'lat': 33.42697, 'lon': -117.61199}}], 'centralContacts': [{'name': 'Michele Ybarra, PhD', 'role': 'CONTACT', 'email': 'michele@innovativepublichealth.org', 'phone': '8773026858', 'phoneExt': '801'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Innovative Public Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Miami', 'class': 'OTHER'}, {'name': 'Ann and Robert H Lurie Childrens Hospital of Chicago', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}