Major Program
US-Latin American-Caribbean U54
Sponsor
Weill Medical College of Cornell University
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT06002126
Cervical cancer is a relatively common cancer among women living with human immunodeficiency virus (HIV). This study will test women for human papillomavirus (HPV) infection of the cervix. The main purpose of this study is to determine the best way to test for damaged areas of the cervix. Damaged areas of the cervix should be treated and removed to prevent cancer of the cervix.
Women in this study will be seen once, twice or three times in a year. Women will provide several samples related to screening for cervical cancer including a swab of the cervix, a self-collected swab of the vagina and urine. Women will have a detailed examination of the cervix called colposcopy and have a few biopsies, or small pinches of the cervix, to look for areas at risk for turning into cancer. If HPV of the cervix is found but treatment of the cervix is not indicated, women will return in 6 months and in 12 months to repeat these tests. Most women will only need 1 visit. Women found to have damaged areas of the cervix at risk for turning into cancer will be referred for treatment.
This protocol will compare different tests to understand the best test to identify women at risk for cervical cancer.
Women in this study will be seen once, twice or three times in a year. Women will provide several samples related to screening for cervical cancer including a swab of the cervix, a self-collected swab of the vagina and urine. Women will have a detailed examination of the cervix called colposcopy and have a few biopsies, or small pinches of the cervix, to look for areas at risk for turning into cancer. If HPV of the cervix is found but treatment of the cervix is not indicated, women will return in 6 months and in 12 months to repeat these tests. Most women will only need 1 visit. Women found to have damaged areas of the cervix at risk for turning into cancer will be referred for treatment.
This protocol will compare different tests to understand the best test to identify women at risk for cervical cancer.
Intervention
S5 DNA methylation classifier, Xpert HPV
Condition
Cervix Cancer, HPV Infection, Cervical High Grade Squamous Intraepithelial Lesion, HIV Infections
Investigators
Timothy Wilkin, MD, MPH, Grant Ellsworth, MD, MS, Lenice Galan de Paula, Eduardo C Lazcano Ponce, MD, Luisa L Villa, PhD, Alejandra J Portillo Romero, MD