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

NCT ID: NCT06651957

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 217 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-10-31

Brief Summary

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

Detailed Description

PRIMARY OBJECTIVE:

I. 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.

OUTLINE:

This is an observational study.

Participants 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Observational

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.

Biospecimen Collection

Intervention Type: OTHER

Specimen swabs will be obtained.

Questionnaires

Intervention Type: OTHER

Given to participants

Interventions

Biospecimen Collection

Specimen swabs will be obtained.

Intervention Type: OTHER

Questionnaires

Given to participants

Intervention Type: OTHER

Other Intervention Names

Specimen Collection; Study-related questionnaires

Eligibility Criteria

Inclusion Criteria

• Documentation of HIV-1 infection by means of any one of the following:

• Documentation of HIV diagnosis in the medical record by a licensed health care provider.
• 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);
• HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL;
• 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.
• NOTE: A "licensed" assay refers to a U.S. FDA-approved assay or an assay approved by the relevant local health authority.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky score ≥ 70%).
• Ability to understand and the willingness to sign a written informed consent document.
• 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.

Exclusion Criteria

• History of inflammatory bowel disease or colorectal cancer
• Participants with active evidence of proctitis.
• Participants who have undergone hysterectomy.
• History of anal cancer, penile, vulvar, vaginal, or cervical cancer.
• Potential participants who received prior treatment of anal, cervical, penile, vaginal, or vulvar lesions within 18 months of study enrollment.
• Inability, in the opinion of the study investigator, of the participant to comply with study requirements.
• Participants who are pregnant (a urine pregnancy test will be provided to participants of age 60 years or less) or within 2 months postpartum.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Palefsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Instituto Nacional de Salud Publica

Cuernavaca, Morelos, Mexico

University of Puerto Rico

San Juan, , Puerto Rico

Countries

United States; Mexico; Puerto Rico

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2024-01760

Identifier Type: REGISTRY

Identifier Source: secondary_id

U54CA242646

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24361

Identifier Type: -

Identifier Source: org_study_id