Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries

Status: Active_not_recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 living with HIV (WLWH) 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: f
View:

• HIV-1 infection, as documented by 1) any FDA approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA, test kit, and confirmed by Western blot or other approved test), OR 2) a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and/or current management of HIV infection, OR 3) documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with two participant identifiers affixed to the bottles or packages.

• Female.

• Aged 25 to 65.

• Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant.

Locations
Other Locations
Brazil
University of São Paulo
São Paulo
Mexico
National Institute of Public Health, Mexico
Cuernavaca
Time Frame
Start Date: 2023-08-02
Completion Date: 2027-03-31
Participants
Target number of participants: 1002
Treatments
Experimental: Cervical cancer screening (single arm)
Women will be screened for cervical cancer with HPV testing that provides extended genotyping and DNA quantification. Women will also provide other samples for cervical cancer screening tests. Women will under cervical biopsies.
Sponsors
Collaborators: University of California, San Diego, University of Sao Paulo, Mexican National Institute of Public Health, Instituto Nacional de Salud Publica, Mexico, H. Lee Moffitt Cancer Center and Research Institute, National Cancer Institute (NCI)
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov