Clinical Trial

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

Study acronym: PROMETA

Recruiting

Summary

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.

Protocol Amendment History 3 changes

critical Recruitment opened 2026-07-21

notable Primary completion moved earlier: 2028-12-31 -> 2028-06-30 2026-07-21

minor Completion moved earlier: 2029-02-28 -> 2028-08-31 2026-07-21

Trial Details

NCT Number	NCT06810739
Lead Sponsor	Tulane University Collaborators: National Cancer Institute (NCI), National Institutes of Health (NIH)
Conditions	Human Papilloma Virus Related Cervical Carcinoma
Enrollment	8,445 participants
Start Date	2026-07-13
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-20