Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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 criteria
Qualifiers
Confirmed HIV-1 infection
Age 25 years and older.
Be willing and able to provide written informed consent.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Urine HPV testing
- Self-collected cervicovaginal specimen
- Provider-collected cervical samples
Treatment groups
300 Participants
are divided into 1 treatment groupLocations
1Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital2092, WestdeneJohannesburg, South Africa
Sponsors and collaborators
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov