Actively Recruiting

Phase Not Applicable
Age: 25Years +
FEMALE
NCT06458062

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

Age: 25Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Kenya Medical Research Institute

Nairobi, Kenya

Actively Recruiting

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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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Pocket Colposcopy Using CARE Algorithm | DecenTrialz