This clinical trial examines urine sample for cervical cancer screening among woman living with human immunodeficiency virus (HIV) infection in South Africa. Urine samples can be tested for human papillomavirus (HPV). Cervical cancer is a cancer of the cells around the entrance to the uterus (also called the mouth of the womb). HPV infection in women can cause changes in the cells that lead to cervical pre-cancer and, eventually, cervical cancer. This study will compare HPV tests on urine, self-collected vaginal samples, and provider-collected cervical samples to see which sample type works best. Using a urine sample to test for HPV infection may help doctors find cervical cancer soon, when it is easier to treat.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05413798.
PRIMARY OBJECTIVE:
I. To determine the clinical performance (sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of high-risk human papillomavirus (hrHPV) testing in urine, self-collected cervicovaginal, and provider-collected cervical samples for the detection of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) in HIV infected women.
SECONDARY OBJECTIVES:
I. To determine the clinical performance of hrHPV testing in urine, self-collected cervicovaginal, and provider-collected cervical samples for the detection of cervical intra-epithelial neoplasia grade 3 or worse (CIN3+) in HIV-infected women.
II. To compare the hrHPV positivity detected in urine, self-collected cervicovaginal, and provider-collected cervical samples.
OUTLINE:
Patients undergo hrHPV testing via urine, cervical, and vaginal specimen collection at screening. Patients also undergo a colposcopy at screening. Patients with CIN2/3 may undergo excisional treatment by large loop electrosurgical excision procedure (LEEP) at week 4.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorCarla Joan Chibwesha
