High-Grade Squamous Intraepithelial Lesions, Human Immunodeficiency Virus, Human Papillomavirus-Related Anal Squamous Cell Carcinoma
Conditions
Keywords
Microbiome
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.
Interventions
OTHERBiospecimen Collection
Specimen swabs will be obtained.
OTHERQuestionnaires
Given to participants
Sponsors
University of California, San Francisco
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate association between with hr-HPV and pro-inflammatory-mediating taxa | Up to 1 year | 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. |
| Association between with hr-HPV and butyrate-producing signatures | Up to 1 year | 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. |
Countries
Mexico, Puerto Rico, United States
Contacts
PRINCIPAL_INVESTIGATORJoel Palefsky, MD
University of California, San Francisco
Outcome results
None listed