NCT06810739

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,445 (estimated)
• Sponsor: Tulane University · Academic / Other
• Sex: Female
• Age: 25 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will use a hybrid type III effectiveness-implementation design. In a hybrid type III design, the primary focus is on testing of an implementation strategy, while simultaneously continuing to observe and gather information on the effectiveness of a clinical intervention, under real world conditions, for which effectiveness data has already largely been determined. Best practices for deploying the Screen-Triage-Treat approach to cervical cancer screening utilizing self-collected human papilloma virus (HPV) deoxyribonucleic acid (DNA) testing within Mozambique´s HIV care and treatment services will be evaluated. The study will employ a mixed-methods approach, collecting both quantitative and qualitative data. The primary outcome of interest is the number of women screened and the proportion of HPV screen-positive women undergoing treatment, while 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.

Conditions

• Human Papilloma Virus Related Cervical Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-06-30
• Completion: 2028-08-31
• First posted: 2025-02-06
• Last updated: 2025-12-17

Locations

1 site across 1 country: Mozambique