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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral. [Срок оценки: 2.5 Years]

Вторичные конечные точки (2)

• Test Result Notification Rate [Срок оценки: 2.5 Years]
• Treatment Rate [Срок оценки: 2.5 Years]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Mozambique · 1 центр

• University Eduardo Mondlane (UEM) — Maputo

Публикации

• 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

Идентификаторы

NCT: NCT06810739 · 2024-1641 · U01CA294674

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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