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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from UNC Lineberger Comprehensive Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Aug 2026 to Aug 2027
    • Eligibility criteria expanded, about 9 words
    • Study description revised
  2. Minor 4 versions Re-verified since Feb 1, 2024, no change to tracked fieldsv8-v11
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 8, 2023 to May 11, 2023
    • Site details revised
    v7
  4. Notable Start date: Jun 8, 2023 to Aug 8, 2023v6
  5. Notable Start date: May 8, 2023 to Jun 8, 2023v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Jan 2023 to May 8, 2023v4
  2. Notable Start date: Aug 2022 to Jan 2023v3
  3. Minor Secondary endpoints revised (2)v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05413798
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)
Cervical Cancer, CIN2, CIN3
Related terms Uterine Cervical Neoplasms
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov