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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorTulane University

About this trial

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.

Eligibility criteria

Qualifiers

Women 25-49 years

Accessing HIV care and treatment services

Not being pregnant

Patients with a cervix

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HPV DNA testing be self-collected vaginal swab

Treatment groups

8,445 Participants
are divided into 1 treatment group

Sponsors and collaborators

Tulane University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institutes of Health (NIH)

Collaborator