Clinical trial NCT06651957: Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Immunodeficiency Virus
Human Papillomavirus-Related Anal Squamous Cell Carcinoma
High-Grade Squamous Intraepithelial Lesions
Keywords: Microbiome
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hispanic participants previously consented to ULACNet-101 study diagnosed with HIV and received antiretroviral therapy

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.

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 on immunosuppressive drugs. Exclusion criteria from ULACNet-101
* 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.

Primary outcomes:
measure: Evaluate association between with hr-HPV and pro-inflammatory-mediating taxa
timeFrame: Up to 2 years
measure: Association between with hr-HPV and butyrate-producing signatures
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Cuernavaca
country: Mexico
facility: Instituto Nacional de Salud Publica
state: Morelos
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: University of California, San Francisco
name: Joel Palefsky, MD
role: PRINCIPAL_INVESTIGATOR
References: