RecruitingNot ApplicableNCT06810739

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

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


Sponsor

Tulane University

Enrollment

8,445 participants

Start Date

Jul 13, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying HPV DNA testing be self-collected vaginal swab for people with human papilloma virus related cervical carcinoma. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 25 Years to 49 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTHPV 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

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NCT06810739