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Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)

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Conditions

Human Immunodeficiency VirusHuman Papillomavirus-Related Anal Squamous Cell CarcinomaHigh-Grade Squamous Intraepithelial LesionsMicrobiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10-31
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06651957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documentation of HIV-1 infection by means of any one of the following:
  2. * Documentation of HIV diagnosis in the medical record by a licensed health care provider.
  3. * 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);
  4. * HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
  5. * 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.
  6. * NOTE: A "licensed" assay refers to a U.S. FDA-approved assay or an assay approved by the relevant local health authority.
  7. * 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.
  8. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky score ≥ 70%).
  9. * Ability to understand and the willingness to sign a written informed consent document.
  10. * 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.
  1. * History of inflammatory bowel disease or colorectal cancer
  2. * Participants with active evidence of proctitis.
  3. * Participants on immunosuppressive drugs. Exclusion criteria from ULACNet-101
  4. * Participants who have undergone hysterectomy.
  5. * History of anal cancer, penile, vulvar, vaginal, or cervical cancer.
  6. * Potential participants who received prior treatment of anal, cervical, penile, vaginal, or vulvar lesions within 18 months of study enrollment.
  7. * Inability, in the opinion of the study investigator, of the participant to comply with study requirements.
  8. * Participants who are pregnant (a urine pregnancy test will be provided to participants of age 60 years or less) or within 2 months postpartum.

Contacts and Locations

Principal Investigator

Joel Palefsky, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Joel Palefsky, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2024-10-31
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

  • Microbiome

Additional Relevant MeSH Terms

  • Human Immunodeficiency Virus
  • Human Papillomavirus-Related Anal Squamous Cell Carcinoma
  • High-Grade Squamous Intraepithelial Lesions