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

NCT06651957 | Completed DMC

• 3 other identifiers: 24361NCI-2024-01760U54CA242646
• Study Type: observational
• Target: 217
• Locations: 3 countries
• Sites: 3

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

Conditions

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

Keywords

Microbiome

Outcome Measures

Primary Outcomes (2)

• Evaluate association between with hr-HPV and pro-inflammatory-mediating taxa

  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.

  Up to 1 year

• Association between with hr-HPV and butyrate-producing signatures

  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.

  Up to 1 year

Study Arms (1)

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.

Other: Biospecimen Collection; Other: Questionnaires

Interventions

Questionnaires OTHER

Given to participants

Also known as: Study-related questionnaires

Observational

Biospecimen Collection OTHER

Specimen swabs will be obtained.

Also known as: Specimen Collection

Observational

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hispanic participants previously consented to ULACNet-101 study diagnosed with HIV and received antiretroviral therapy

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Instituto Nacional de Salud Publica

Cuernavaca, Morelos, 62100, Mexico

Location

University of Puerto Rico

San Juan, 00936, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Anal swabs will be obtained for analysis

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Squamous Intraepithelial Lesions

Interventions

Specimen Handling; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Joel Palefsky, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: October 31, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ME (1); US (1); PR (1)