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Optimization of Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People Living with HIV in Mexico and Puerto Rico
Trial Status: active
This study aims to find what different tests work best to find high-grade squamous intraepithelial lesions (HSIL) in the cervix or anus in patients living with human immunodeficiency virus (HIV). Patients with HIV are at high risk of becoming infected with human papillomavirus (HPV) in the cervix or anus where it can turn into cancer over several years. HPV causes changes to the cervix and anus, known as HSIL. This means that there is an area of abnormal tissue on the top layers of the cervix or anus. It is considered cervical or anal cancer if the abnormality spreads down into the layers of tissue below the top. If found early, many cases of HSIL can be treated before turning into cancer. Screening for cervical or anal cancer detection or HSIL associated with HPV may result in earlier treatment, if necessary, for patients living with HIV.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05074264.
I. Evaluate the most efficient algorithm combining HPV-based screening with several triage alternatives: cytology, extended high risk HPV (hrHPV) genotyping, p16/Ki-67 dual stain cytology, E6 and/or E7 oncoprotein detection and S5 methylation, to improve the current screening program for detection of anogenital HPV-related cancers and pre-cancers, in men and women living with HIV in Mexico and Puerto Rico.
EXPLORATORY OBJECTIVES:
I. Evaluate artificial intelligence-based algorithms based on cell-phone images of the cervix for their sensitivity, specificity, and negative and positive predictive values for cervical cancers and pre-cancers in women living with HIV in Mexico and Puerto Rico.
II. Evaluate the HPV agreement/concordance between cervicovaginal samples collected by participants and cervical samples collected by clinicians.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (WOMEN LIVING WITH HIV [WLWH]): Patients undergo collection of cervical images, 3 clinician-collected cervical swabs, 1 self-collected cervicovaginal swab, and 3 clinician-collected anal swabs for real-time testing of hrHPV over 90 minutes. Patients undergo colposcopy and biopsies of visible lesions and undergo high-resolution anoscopy at the same time or at a later visit within 1 month. Patients diagnosed with HSIL may undergo standard of care (SOC) treatment or enroll in additional studies when they are open to accrual.
ARM II (MEN LIVING WITH HIV [MLWH]): Patients undergo collection of 3 clinician-collected anal swabs for real-time testing of hrHPV over 90 minutes. Patients undergo high-resolution anoscopy with biopsies of visible lesions. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual.
