Clinical trial NCT06810739: The Women's Screening and Self-Testing Program (PROMETA) Study
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Human Papilloma Virus Related Cervical Carcinoma
Keywords: Human Immunodeficiency Virus
Self swab
Mozambique
Cervical cancer
Implementation science
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2025-02-06
Enrollment: 8400
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women accessing health care for HIV care and treatment services at the selected study sites

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.

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

Primary outcomes:
measure: The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral.
timeFrame: 2.5 Years
Secondary outcomes:
measure: Test Result Notification Rate
timeFrame: 2.5 Years
measure: Treatment Rate
timeFrame: 2.5 Years
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: University Eduardo Mondlane (UEM)
Study officials:
affiliation: Tulane University
name: Troy Moon, MD
role: PRINCIPAL_INVESTIGATOR
References: