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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: UNC Lineberger Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT05413798

Registry updated: 2026-09-30
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Description

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.

Interventions

  • Urine HPV testing (Other)
    Human papillomavirus (HPV) testing in urine sample.
  • Self-collected cervicovaginal specimen (Other)
    Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample.
  • Provider-collected cervical samples (Other)
    Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample.

Eligibility criteria

Inclusion Criteria: In order to participate in this study a subject must meet all of the eligibility criteria outlined below. 1. Confirmed HIV-1 infection 2. Age 25 years and older. 3. Be willing and able to provide written informed consent. Exclusion Criteria: 1. Pregnant or intend to become pregnant within 90 days of enrollment 2. Have been screened for cervical cancer within the preceding year (365 days) 3. Have an active sexually transmitted infection (STI; women may participate once treated) 4. Have a surgically absent cervix 5. Have a history of cervical cancer 6. have been vaccinated against HPV.

Conditions

Cervical Cancer CIN2 CIN3

Locations

  • Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital — Westdene, Johannesburg, South Africa
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record