Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa

Recruiting now · Not applicable

Conditions studied: Cervical Cancer, CIN2, CIN3

In brief

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.

Key facts

Study ID

NCT05413798

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

300

Starts

2023-05-11

Expected to finish

2026-08-01

Last updated by the study team

2026-07-01

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant or intend to become pregnant within 90 days of enrollment
• Have been screened for cervical cancer within the preceding year (365 days)
• Have an active sexually transmitted infection (STI; women may participate once treated)
• Have a surgically absent cervix
• Have a history of cervical cancer
• have been vaccinated against HPV.

Where it is running

• Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital — Westdene, Johannesburg, South Africa (enrolling)

Full record on ClinicalTrials.gov

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