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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05074264.
PRIMARY OBJECTIVE:
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.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUCSF Medical Center-Parnassus
Principal InvestigatorJoel Palefsky
