Pocket Colposcopy Using CARE Algorithm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorDuke University
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH)
Sex: Female
Positive HPV test within past 6 months
Disqualifiers
Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
Women with a negative HPV test within the past 9 months
Patients incapable of giving informed consent
Women with a history of cervical cancer
Trial design
Treatments tested in this trial
- Pocket Colposcope
Treatment groups
1,079 Participants
are divided into 1 treatment groupSponsors and collaborators
Duke University
Lead sponsor
Kenya Medical Research Institute
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov