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The Women's Screening and Self-Testing Program (PROMETA) Study

Study acronym: PROMETA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Primary completion moved earlier from Dec 31, 2028 to Jun 30, 2028
    • Study completion moved earlier from Feb 28, 2029 to Aug 31, 2028
    • Site details revised
    v4
  2. Primary completion date: Jun 30, 2028 to Dec 31, 2028
    • Start date: Jan 1, 2026 to Jul 13, 2026
    • Study completion date: Aug 31, 2028 to Feb 28, 2029
    v3
  3. Phase: Not specified to Not applicablev2 Show 5 more changesShow less
    • Primary completion date: Jan 2031 to Jun 30, 2028
    • Enrollment target: 8400 to 8445
    • Study completion date: Jan 2031 to Aug 31, 2028
    • Start date: Jan 2026 to Jan 1, 2026
    • Interventions: Cervical Cancer Screen-Triage-Treat Care Cascade (Diagnostic Test) to HPV DNA testing be self-collected vaginal swab (Diagnostic Test)
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This proposal directly addresses the ability to safely scale-up a Screen-Triage-Treat approach to cervical cancer screening. The investigators propose to capitalize on a pool of screen-eligible women accessing routine care within targeted human immunodeficiency virus (HIV) care and treatment services. The primary outcome of interest is the number of women screened and the proportion of screen-positive women undergoing treatment. Secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.
Trial Details
NCT Number NCT06810739
Lead Sponsor Tulane University
Collaborators: National Cancer Institute (NCI), National Institutes of Health (NIH)
Conditions
(from sponsor)		 Human Papilloma Virus Related Cervical Carcinoma
Related terms Acquired Immunodeficiency Syndrome, Uterine Cervical Neoplasms
Enrollment 8,445 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov