NCT06651957

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 217 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Biospecimen Collection	Specimen swabs will be obtained.
OTHER	Questionnaires	Given to participants

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2024-10-22
• Last updated: 2025-12-10

Locations

3 sites across 3 countries: United States, Mexico, Puerto Rico