Actively Recruiting
Pocket Colposcopy Using CARE Algorithm
Led by Duke University · Updated on 2026-01-12
1079
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
K
Kenya Medical Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Pocket colposcope has 510k FDA clearance and has been successfully used in \~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at four Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.
CONDITIONS
Official Title
Pocket Colposcopy Using CARE Algorithm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 30 to 64 years, or women aged 25 years and older if living with HIV
- Female sex
- Positive HPV test within the past 6 months
You will not qualify if you...
- Pregnant women (cervical biopsy not performed unless absolutely necessary)
- Women with a negative HPV test within the past 9 months
- Patients unable to give informed consent
- Women with a history of cervical cancer
- Pelvic exam showing signs of cervical cancer or cervical infection
- History of hysterectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kenya Medical Research Institute
Nairobi, Kenya
Actively Recruiting
Research Team
M
Megan Huchko, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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