A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 49
Healthy Volunteers: f
View:
• Women 25-49 years
• Accessing HIV care and treatment services
• Not being pregnant
• Patients with a cervix
Locations
Other Locations
Mozambique
University Eduardo Mondlane (UEM)
RECRUITING
Maputo
Contact Information
Primary
Kathryn Kampa, MPH
kkampa@tulane.edu
651-983-1076
Backup
Harriett Myers, MPH
hmyers5@tulane.edu
828-292-1742
Time Frame
Start Date: 2026-07-13
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 8445
Treatments
Experimental: HPV DNA testing from self-collected vaginal swab
After providing informed consent, the study clinician will open a Case Report Form (CRF) for each patient which starts with a brief questionnaire which will include the participant's demographic information and medical history, including HIV viral load and CD4 counts, previous cervical cancer screening results if previously screened, and result of rapid pregnancy test performed that day with a urine sample. Each participant will then be accompanied to a private location where the study nurse will provide counseling and instruction on how to appropriately perform the self-collection vaginal swab technique. Data on HPV testing, VAT results, and referrals along each step of the process will be documented in the CRF.
Related Therapeutic Areas
Sponsors
Leads: Tulane University
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)