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

RecruitingNAAges 25 Years - anyFemaleUNC Lineberger Comprehensive Cancer Center
NCT05413798 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Urine HPV testing
  • Self-collected cervicovaginal specimen
  • Provider-collected cervical samples
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Where

1 site
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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