Pocket Colposcopy Using CARE Algorithm
Recruiting
N/A
Interventional Study
Cervical Cancer
HPV Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 25 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,079 (estimated)
- Sponsor
- Duke University · Other
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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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH)
2. Sex: Female
3. Positive HPV test within past 6 months
Exclusion Criteria:
1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indic…
Contacts