Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT06651957
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2024-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}], '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'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-10', 'size': 534209, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-01T21:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Anal swabs will be obtained for analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate association between with hr-HPV and pro-inflammatory-mediating taxa', 'timeFrame': 'Up to 1 year', 'description': 'Among Hispanic PLWH without anal high-grade squamous intraepithelial lesions (HSIL), the investigators hypothesize the microbiome will be different between those with and without hr-HPV infection and the proportion with pro-inflammatory-mediating taxa will be highest among the Puerto Rican population compared with the Mexican and California populations given the higher incidence in anal cancer in Puerto Rico.'}, {'measure': 'Association between with hr-HPV and butyrate-producing signatures', 'timeFrame': 'Up to 1 year', 'description': 'Among Hispanic PLWH with anal hr-HPV at the three locations, the investigators hypothesize the detection of HSIL will be associated with a pro-inflammatory microbiome and a decrease in butyrate-producing signatures, with the proportion of pro-inflammatory changes highest among the Puerto Rican population compared with the Mexican and California populations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome'], 'conditions': ['Human Immunodeficiency Virus', 'Human Papillomavirus-Related Anal Squamous Cell Carcinoma', 'High-Grade Squamous Intraepithelial Lesions']}, 'descriptionModule': {'briefSummary': 'The study evaluates if there is relationship between the kinds of bacteria living in the anus (also known as the anal microbiome) and the risk of human papillomavirus (HPV) infection or HPV-related pre-cancer (high-grade squamous intraepithelial lesions or HSIL) in Hispanic people living with HIV (PLWH) in Puerto Rico, Mexico and California', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Study the relationship between anal high-risk HPV (hr-HPV) infection and the anal microbiome among three distinct populations of Hispanic people living with HIV (PLWH) in Mexico, Puerto Rico, and California.\n\nOUTLINE:\n\nThis is an observational study.\n\nParticipants undergo collection of 3 anal swab samples, complete questionnaires, and have their medical records reviewed on study. Participants with visible lesions undergo high resolution anoscope with anal biopsy per usual care on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hispanic participants previously consented to ULACNet-101 study diagnosed with HIV and received antiretroviral therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documentation of HIV-1 infection by means of any one of the following:\n\n * Documentation of HIV diagnosis in the medical record by a licensed health care provider.\n * Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant\'s medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant\'s name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone (e.g., Truvada), which is exclusionary);\n * HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \\>1000 RNA copies/mL;\n * Any locally licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n * NOTE: A "licensed" assay refers to a U.S. FDA-approved assay or an assay approved by the relevant local health authority.\n* Age 21 years or older. Cervical HSIL/cancer screening does not usually begin until 20 years of age or older. Also, anal HSIL/cancer screening among high-risk individuals such as people living with HIV is recommended for those 25 years of age or older. Children under the age of 18 are at low risk of developing cervical or anal HSIL/cancer and will not benefit from the kind of screening planned for this study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky score ≥ 70%).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Previous consent to participate in ULACNet-101 in Mexico and Puerto Rico sites or a patient at Anal Neoplasia Clinic, Research and Education (ANCRE) Center in San Francisco.\n\nExclusion Criteria:\n\n* History of inflammatory bowel disease or colorectal cancer\n* Participants with active evidence of proctitis.\n* Participants on immunosuppressive drugs. Exclusion criteria from ULACNet-101\n* Participants who have undergone hysterectomy.\n* History of anal cancer, penile, vulvar, vaginal, or cervical cancer.\n* Potential participants who received prior treatment of anal, cervical, penile, vaginal, or vulvar lesions within 18 months of study enrollment.\n* Inability, in the opinion of the study investigator, of the participant to comply with study requirements.\n* Participants who are pregnant (a urine pregnancy test will be provided to participants of age 60 years or less) or within 2 months postpartum.'}, 'identificationModule': {'nctId': 'NCT06651957', 'acronym': 'ULACNet-104', 'briefTitle': 'Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Relationship Between Anal High-Risk HPV (Hr-HPV) Infection, Anal High-Grade Squamous Intraepithelial Lesions (HSIL), and the Anal Microbiome Among Three Distinct Populations of Hispanic People Living With HIV (PLWH) in California, Mexico and Puerto Rico', 'orgStudyIdInfo': {'id': '24361'}, 'secondaryIdInfos': [{'id': 'NCI-2024-01760', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}, {'id': 'U54CA242646', 'link': 'https://reporter.nih.gov/quickSearch/U54CA242646', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Participants undergo collection of 3 anal swab samples, complete questionnaires, and have their medical records reviewed on study. Participants with visible lesions undergo non-investigational high resolution anoscope with a non-investigational anal biopsy per usual care on study.', 'interventionNames': ['Other: Biospecimen Collection', 'Other: Questionnaires']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'OTHER', 'otherNames': ['Specimen Collection'], 'description': 'Specimen swabs will be obtained.', 'armGroupLabels': ['Observational']}, {'name': 'Questionnaires', 'type': 'OTHER', 'otherNames': ['Study-related questionnaires'], 'description': 'Given to participants', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '62100', 'city': 'Cuernavaca', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'Instituto Nacional de Salud Publica', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}, {'zip': '00936', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Joel Palefsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'De-identified data will be shared with research collaborators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}