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

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 careprovider.

• Documentation of receipt of antiretroviral therapy (ART) by a licensed healthcare provider (Documentation may be a record of an ART prescription in theparticipant's medical record, a written prescription in the name of theparticipant for ART, or pill bottles for ART with a label showing theparticipant's name. Receipt of at least two agents is required; each componentagent 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 RNAcopies/mL;

• Any locally licensed HIV screening antibody and/or HIV antibody/antigencombination assay confirmed by a second licensed HIV assay such as a HIV-1Western blot confirmation or HIV rapid multispot antibody differentiationassay.

• NOTE: A "licensed" assay refers to a U.S. FDA-approved assay or an assayapproved 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-riskindividuals such as people living with HIV is recommended for those 25 years of ageor older. Children under the age of 18 are at low risk of developing cervical oranal HSIL/cancer and will not benefit from the kind of screening planned for thisstudy.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky score ≥ 70%).

• Ability to understand and the willingness to sign a written informed consentdocument.

• Previous consent to participate in ULACNet-101 in Mexico and Puerto Rico sites or apatient at Anal Neoplasia Clinic, Research and Education (ANCRE) Center in SanFrancisco.

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 complywith study requirements.

• Participants who are pregnant (a urine pregnancy test will be provided toparticipants of age 60 years or less) or within 2 months postpartum.