Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT06056661
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2023-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Within My Reach (WMR) Adaptation
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability, as measured by the Acceptability of Intervention Measure (AIM)', 'timeFrame': 'Up to 3 months', 'description': 'The AIM consists of four questions that assess acceptability. Responses range from 1 (completely disagree) to 5 (completely agree). Scales are created by averaging responses.'}, {'measure': 'Appropriateness, as measured by the Intervention Appropriateness Measure (IAM)', 'timeFrame': 'Up to 3 months', 'description': 'The IAM consists of four questions that assess appropriateness. Responses range from 1 (completely disagree) to 5 (completely agree). Scales are created by averaging responses.'}], 'secondaryOutcomes': [{'measure': 'Change in Sexual Risk Composite, as measured by HIV risk assessment', 'timeFrame': 'Baseline compared to up to 3 months', 'description': "Participants will answer questions about engagement in anal or vaginal sex, sexual partners' HIV status, current pre-exposure prophylaxis (PrEP) use and adherence (if HIV-negative or unknown HIV status), viral load (if living with HIV), A composite score will be calculated to determine whether or not the participant engaged in sexual behavior that could lead to HIV transmission or acquisition. A score of 1 means that the participant engaged in sexual behavior that could lead to HIV acquisition or transmission. A score of 0 means that they did not."}, {'measure': 'Change in Acceptance of Couple Violence', 'timeFrame': 'Baseline compared to up to 3 months', 'description': 'The outcome will be measured with the five-item general violence subscale from the Acceptance of Couple Violence Scale. The items will be rated on a scale from 1 (strongly disagree) to 4 (strongly agree). Scales are created by averaging responses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hiv', 'Violence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to adapt a relationship education program. The research team is adapting so that it is helpful for Latino sexual minority men.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Identifies as a man', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n* Identify as Latino/e/x or Hispanic\n* Age 18 years or older\n* Currently reside in Miami-Dade County or Broward County\n* Identify as gay, bisexual, or other non-heterosexual identity\n* Identify as a man\n* Comfortable speaking English\n\nExclusion:\n\n* Unable to provide consent\n* Deemed that participating would be potentially harmful to the participant or research staff'}, 'identificationModule': {'nctId': 'NCT06056661', 'briefTitle': 'Within My Reach (WMR) Adaptation', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Culturally Adapting Individually-oriented Relationship Education (Within My Reach) for Latino Sexual Minority Men', 'orgStudyIdInfo': {'id': '20221114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WMR group', 'description': 'Participants in this group will receive the WMR program for up to 5 weeks.', 'interventionNames': ['Behavioral: WMR']}], 'interventions': [{'name': 'WMR', 'type': 'BEHAVIORAL', 'description': 'Participants will complete up to five sessions that will take 2 hours each. Sessions will take place in person. Participants will learn skills related to getting into and out of romantic relationships and identifying and pursuing goals for romantic relationships.', 'armGroupLabels': ['WMR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Audrey Harkness, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mental Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Audrey Harkness', 'investigatorAffiliation': 'University of Miami'}}}}