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NOT YET RECRUITING
NCT06810739
NA

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

Sponsor: Tulane University

View on ClinicalTrials.gov

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.

Official title: A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique

Key Details

Gender

FEMALE

Age Range

25 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

8445

Start Date

2026-01-01

Completion Date

2028-08-31

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

HPV DNA testing be self-collected vaginal swab

Directly following collection of the vaginal self-swab sample, the participant will be taken back to the waiting area and her sample will be taken to the laboratory for HPV testing using the Xpert HPV Test on the GeneXpert platform (Cepheid, Sunnyvale, CA, USA). This point-of-care test takes approximately 45 minutes to get results.

Locations (1)

University Eduardo Mondlane (UEM)

Maputo, Mozambique