Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:15 PM
Study NCT ID:
NCT07475702
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moon and Sun Brothers: A Community Prevention Intervention (Hermanos de Luna y Sol)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000066505', 'term': 'Help-Seeking Behavior'}, {'id': 'D047568', 'term': 'Unsafe Sex'}, {'id': 'D000073599', 'term': 'Health Risk Behaviors'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016081', 'term': 'Moon'}], 'ancestors': [{'id': 'D018534', 'term': 'Earth, Planet'}, {'id': 'D016083', 'term': 'Planets'}, {'id': 'D016082', 'term': 'Solar System'}, {'id': 'D055587', 'term': 'Astronomical Objects'}, {'id': 'D055580', 'term': 'Astronomical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is designed as a quasi-experimental, with a community intervention group and a control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported condomless anal intercourse', 'timeFrame': 'From baseline to end the of intervention, at twelve months.'}], 'secondaryOutcomes': [{'measure': 'Self-Esteem', 'timeFrame': 'From enrollment to the end of intervention at 12 months', 'description': 'We will assess self-esteem using the 20-item Inner Strength Scale adapted for this study with response options and corresponding scores as follows: never (0), rarely (1), sometimes (2), often (4) and very often (4). The scores ranged from 0 to 80 with higher scores denoting higher degrees of inner strength.'}, {'measure': 'Social Support', 'timeFrame': 'From enrollment to the end of intervention, at 12 months.', 'description': 'We will assess social support using a 20-item questionnaire developed by Krause, measuring social embeddedness (contact with friends and family) and enacted support from others (which entail emotional, tangible and informational support). These items are scored (coding in parentheses) based on the following responses: never (0), rarely (1), sometimes (2), often (3) and very often (4). The scores range from 0-80, with higher scores denoting a higher degree of social support.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Help-Seeking Behavior', 'Pre-exposure Prophylaxis Use', 'Condomless Sex', 'Risky Health Behavior']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://publichealth.sfsu.edu/node/231/', 'label': 'Website to promote the study'}]}, 'descriptionModule': {'briefSummary': 'The goal of this quasi-experimental, community intervention is to reduce HIV sexual risk among Latino immigrant bisexual men or men who have sex with men. The main questions the study aims to answer are:\n\nDoes the intervention improve sexual risk behaviors? Does the intervention increase self-esteem and social support? Are self-esteem and social support mediators in the link between the intervention and sexual risk? Researchers will compare information from the intervention versus control participants to answer the above questions.\n\nParticipants in the intervention arm will take part in:\n\n* One day-long (8-hour) group retreat.\n* Weekly discussion groups.\n* Community events and civic engagement activities.\n* Prevention counseling. Participants in the control arm will not be part of any activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-identified male, which includes transmasculine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as male.\n* Latino/x/e\n* Report having sex with men only, or both men and women in the last 12 months.\n* Speaks, reads/writes in Spanish.\n* ≥18 years of age.\n* Has access to a computer, laptop, tablet or smart phone device.\n* Be willing to participate in the study.\n* Be able to provide informed consent.\n\nExclusion Criteria:\n\n* Populations younger than 18 years.\n* Individuals who have participated in an Hermanos de Luna y Sol program in either the intervention or control group locations.'}, 'identificationModule': {'nctId': 'NCT07475702', 'briefTitle': 'Moon and Sun Brothers: A Community Prevention Intervention (Hermanos de Luna y Sol)', 'organization': {'class': 'OTHER', 'fullName': 'San Francisco State University'}, 'officialTitle': 'Moon and Sun Brothers: A Community Prevention Intervention (Hermanos de Luna y Sol)', 'orgStudyIdInfo': {'id': '2025-123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention Community', 'description': 'Over the course of twelve months, study participants will participate in: 1) One day-long (8-hour) group retreat (dosage: 100%); 2) Weekly discussion groups (dosage: minimum of 50% of weekly sessions); 3) Community participation (dosage: minimum of 5 civic engagement activities; 50% of community events); and 4) Prevention counseling sessions (dosage: minimum of 1 session). Intervention participants will take part in all four components.', 'interventionNames': ['Behavioral: Moon and Sun Brothers: A Community Prevention Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Community', 'description': 'Participants in the control arm will be unexposed to the intervention components.'}], 'interventions': [{'name': 'Moon and Sun Brothers: A Community Prevention Intervention', 'type': 'BEHAVIORAL', 'description': 'The is a community-based, group intervention delivered in Spanish, using a quasi-experimental design, to reduce HIV sexual risk among Hispanic immigrants who identify as gay/bisexual men or men who have sex with men (GBMSM).', 'armGroupLabels': ['Intervention Community']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94132', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma V Sanchez-Vaznaugh, ScD', 'role': 'CONTACT', 'email': 'emmav@sfsu.edu', 'phone': '415-405-2832'}, {'name': 'Maria E Acosta, MPH', 'role': 'CONTACT', 'email': 'macosta3@sfsu.edu', 'phone': '415-405-2832'}, {'name': 'Rita Melendez, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'San Francisco State University', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pedro A Serrano, MPH, DrPH (c)', 'role': 'CONTACT', 'email': 'pserrano@sfsu.edu', 'phone': '708-683-9304'}], 'facility': 'Chicago Queer Latine Collaborative', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Emma V Sanchez-Vaznaugh, ScD', 'role': 'CONTACT', 'email': 'emmav@sfsu.edu', 'phone': '415-405-2832'}, {'name': 'Rita Melendez, PhD', 'role': 'CONTACT', 'email': 'rmelende@sfsu.edu'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'The IPD and supporting information will be available after all specific analyses have been completed (on or about 7/31/2029), and available 36 months thereafter.', 'ipdSharing': 'YES', 'description': 'De-identified Individual participant data collected as part of this intervention.', 'accessCriteria': 'Researchers engaged in independent scientific research may request access to the IPD by submitting a research proposal and a statistical analysis plan. After review and approval of the proposal, a signed data sharing agreement is required before the data can be accessed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Francisco State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Drexel University', 'class': 'OTHER'}, {'name': 'Chicago Queer Latine Collaborative', 'class': 'UNKNOWN'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}