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

Not yet recruiting

• Conditions: Human Papilloma Virus Related Cervical Carcinoma

• Registration Number: NCT06810739
• Lead Sponsor: Tulane University

Brief 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.

Study Timeline

• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Study Start: 2026-01
• Primary Completion: 2031-01
• Study Completion: 2031-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 8400

Inclusion Criteria

• Women 25-49 years
• Accessing HIV care and treatment services
• Not being pregnant
• Patients with a cervix

Exclusion Criteria

• Physical or mental impairment that inhibits participation in the study
• Pregnant women or <6 weeks post-partum
• Women who have undergone a total hysterectomy with removal of the cervix

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral.	2.5 Years	Baseline data will be retrospectively collected for the prior 12 months at each of the selected study sites, including the number of women accessing care for HIV care and treatment services each month; the number of women screened for cervical cancer through standard of care protocols; the proportion of screen-positive women who then received treatment or referral for treatment, and the length of time between screening positive and receiving treatment if appropriate.

Secondary Outcome Measures

Name	Time	Method
Test Result Notification Rate	2.5 Years	The proportion of women who were notified of their HPV DNA test result on the same day as sample collection.
Treatment Rate	2.5 Years	The proportion of screen-positive women who were treated with thermal ablation, if appropriate, or referred for higher level of care or return appointment.

Trial Locations

Locations (1)

University Eduardo Mondlane (UEM); 🇲🇿 Maputo, Mozambique