Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-01 @ 4:41 PM
Study NCT ID:
NCT06055868
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2023-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D003075', 'term': 'Coitus'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017144', 'term': 'Focus Groups'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess participant perceptions about OSCC/OPSCC and HPV vaccination', 'timeFrame': 'During focus group, 1 day', 'description': 'FGDs will be transcribed, coded, and the focus group guide will be updated following the Grounded Theory qualitative research methodology. The "data" from the FGD are the audio recordings and the transcripts. The digital transcript of each focus group will be uploaded to the software MAXQDA to aid with coding and analysis in assessing information on participant\'s perception of causes, risk factors, prevention, and screening for OSCC/OPSCC and HPV vaccination.'}, {'measure': 'Assess participant knowledge about OSCC/OPSCC and HPV vaccination', 'timeFrame': 'During focus group, 1 day', 'description': 'FGDs will be transcribed, coded, and the focus group guide will be updated following the Grounded Theory qualitative research methodology. The "data" from the FGD are the audio recordings and the transcripts. The digital transcript of each focus group will be uploaded to the software MAXQDA to aid with coding and analysis in assessing information on participant\'s knowledge of causes, risk factors, prevention, and screening for OSCC/OPSCC and HPV vaccination'}], 'primaryOutcomes': [{'measure': 'Identification of potential oral health equity factors', 'timeFrame': 'Up to 3 days', 'description': 'Participants will complete a baseline questionnaire which will aid in the formation of the focus group with other individuals of shared identity. The Focus Group Discussions (FGDs) will be transcribed, coded, and the focus group guide will be updated following the Grounded Theory qualitative research methodology. The "data" from the FGD are the audio recordings and the transcripts. The digital transcript of each focus group will be uploaded to the software MAXQDA to aid with coding and analysis in identifying individual, interpersonal, and structural factors, if any, that may impact accessing oral health care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Equity', 'Focus Group', 'Sexual and Gender Minority', 'People living with HIV', 'HPV, human papillomavirus'], 'conditions': ['HIV Infections', 'Oral Squamous Cell Carcinoma', 'Oropharyngeal Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39317508', 'type': 'DERIVED', 'citation': 'Hernandez AL, Lingas EO, Juarez W, Villa A, Palefsky J. Using an anti-racist research framework to design studies of oral human papillomavirus and oropharyngeal cancer in San Francisco: rationale and protocol for the Health Equity and Oral Health in People living with HIV (HEOHP) qualitative study. BMJ Open. 2024 Sep 24;14(9):e091474. doi: 10.1136/bmjopen-2024-091474.'}]}, 'descriptionModule': {'briefSummary': 'This is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial/ethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) /Oropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC/OPSCC prevention.', 'detailedDescription': 'OBJECTIVES:\n\n1. To identify individual, interpersonal, and structural oral health equity factors (e.g., internalized stigma; enacted stigma; transportation/hours) that serve as barriers or facilitators to accessing regular and appropriate oral health care, among PLWH of intersecting racial/ethnic and SGM groups.\n2. To explore knowledge and perceptions about causes, risk factors, prevention, and screening for OSCC/OPSCC and HPV vaccination and if identity group membership influences knowledge and perceptions of these issues.\n3. To elicit recommendations for improving access to regular and appropriate oral health care, and suggestions on how to engage PLWH from diverse identity groups in prevention interventions.\n\nOUTLINE:\n\nThere will be one screening and enrollment phone call and only one study visit for the Focus Group Discussions (FDGs). A short quantitative survey will be administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People living with HIV who identify with one or more racial/ethnic/ sexual or gender minority groups', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be 18-years old or older.\n* Participants must be individuals living with HIV\n* Ability to speak and understand English\n* Identify as one or more racial/ethnic minority groups or sexual and gender minority groups\n* All genders and members of all races and ethnic groups are eligible for this study.\n\nExclusion Criteria:\n\n* Younger than 18-years old.\n* Not living with HIV.\n* Not able to speak and understand English.\n* Not classified as one or more racial/ethnic minority groups or sexual and gender minority groups.'}, 'identificationModule': {'nctId': 'NCT06055868', 'briefTitle': 'People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'People Living With HIV (PLWH), Oral and Oropharyngeal Cancer, and Health Equity: A Qualitative Study', 'orgStudyIdInfo': {'id': '23363'}, 'secondaryIdInfos': [{'id': 'R03DE032972', 'link': 'https://reporter.nih.gov/quickSearch/R03DE032972', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Qualitative Focus Group', 'description': 'Participants will be asked to a series of questions to help place them in a focus group with other individuals of shared identity and will also complete a short quantitative survey either emailed to the participant or the outreach worker/study coordinator will administer the survey by phone. Participants will then participate in one 1.5-2 hour, facilitated, focus group discussions (FGD).', 'interventionNames': ['Other: Group Meeting (Focus Group)', 'Other: Questionnaires']}], 'interventions': [{'name': 'Group Meeting (Focus Group)', 'type': 'OTHER', 'description': 'Focus Group Discussions (FDGs) will be recorded, transcribed, and coded.', 'armGroupLabels': ['Qualitative Focus Group']}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Given electronically or via phone by study team staff', 'armGroupLabels': ['Qualitative Focus Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Juarez', 'role': 'CONTACT', 'email': 'William.Juarez@ucsf.edu', 'phone': '415-437-7439'}, {'name': 'Alexandra Hernandez Levenston, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joel Palefsky, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'William Juarez', 'role': 'CONTACT', 'email': 'William.Juarez@ucsf.edu', 'phone': '(415) 437-7439'}], 'overallOfficials': [{'name': 'Alexandra Hernandez Levenston, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}