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 group

Sponsors and collaborators

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator