Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Sep 29, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the best ways to test for high-grade squamous intraepithelial lesions (HSIL) in the cervix and anus of people living with HIV. Since those with HIV have a higher risk of getting HPV, which can lead to abnormal changes called HSIL that might develop into cancer over time, early detection is important. If HSIL is found early, it can often be treated before it becomes cancer. The goal is to see which screening methods work best to help catch these changes early.

To be eligible for this study, participants must be at least 21 years old and have a documented HIV infection. They should also be in good enough health to participate, meaning they can perform daily activities without major issues. Participants will undergo different screening tests and will have the opportunity to help improve how we detect potential cancer risks in people with HIV. This study is currently recruiting participants, and it’s important to note that those who are pregnant or have had certain types of cancer or treatments recently will not be eligible. Overall, this research aims to make screening more effective for people living with HIV.

Gender

ALL

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 ribonucleic acid (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 United States (U.S.) Food and Drug Administration (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
• Exclusion Criteria:
• • 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 aged 60 years or less) or within 2 months being post-partum