Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study explores the usefulness of urine samples for cervical cancer screening in human immunodeficiency virus (HIV)-infected women. Cervical cancer occurs when women are infected with the human papillomavirus (HPV), which can cause changes in the cells that lead to cervical precancer and, eventually, cervical cancer if untreated. However, urine HPV testing has not been well validated low- and middle-income country settings, with no data available to guide its use in HIV-infected women.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Healthy Volunteers: f
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⁃ In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
• Confirmed HIV-1 infection
• Age 25 years and older.
• Be willing and able to provide written informed consent.
Locations
Other Locations
South Africa
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
RECRUITING
Westdene
Contact Information
Primary
Cheryl Hendrickson
cheryl_hendrickson@med.unc.edu
919-843-2541
Time Frame
Start Date: 2023-05-11
Estimated Completion Date: 2026-08
Participants
Target number of participants: 300
Treatments
Other: Single Arm
This is a single arm study. All participants will receive same interventions.
Related Therapeutic Areas
Sponsors
Leads: UNC Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)