Tulane University
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.
Human Papilloma Virus Related Cervical Carcinoma
Cervical Cancer Screen-Triage-Treat Care Cascade
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 Type : | OBSERVATIONAL |
| Estimated Enrollment : | 8400 participants |
| Official Title : | The PROMETA Study: A Hybrid Type III Effectiveness - Implementation Study Designed to Test Implementation Best Practices of Deploying a Screen-Triage-Treat Approach to Cervical Cancer Screening Utilizing Self-collected HPV DNA Testing in Chókwè District, Mozambique |
| Actual Study Start Date : | 2026-01 |
| Estimated Primary Completion Date : | 2031-01 |
| Estimated Study Completion Date : | 2031-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 25 Years to 49 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
University Eduardo Mondlane (UEM)
Maputo, Mozambique,