The Women's Screening and Self-Testing Program (PROMETA) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HPV DNA testing be self-collected vaginal swab.
- Who it may be relevant to
- Registry conditions: Human Papilloma Virus Related Cervical Carcinoma. Basic parameters: 25 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mozambique
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique
Overview
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.
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.
Primary outcome measures
- The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral. [Time frame: 2.5 Years]
Secondary outcome measures (2)
- Test Result Notification Rate [Time frame: 2.5 Years]
- Treatment Rate [Time frame: 2.5 Years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Mozambique · 1 center
- University Eduardo Mondlane (UEM) — Maputo
Publications
- Moon TD, Salcedo MP, Mavume-Mangunyane E, Sidat M, Lorenzoni C, Baker E, Amorim G, Paz-Soldan VA, Kampa KT, Condon K, Myers H, Sacarlal J. A hybrid type III effectiveness-implementation study designed to test implementation best practices of deploying a Screen-Triage-Treat approach to cervical cancer screening and management utilizing self-collected HPV DNA testing in Chokwe District, Mozambique. PMID 41291606
Identifiers
NCT: NCT06810739 · 2024-1641 · U01CA294674