1:1 Comparison of the Pocket Colposcope in Kenya

Not Applicable

Completed

Brief Summary: The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope

Detailed Description: Women randomized to the standard-of-care arm will undergo VIA followed by Visual Inspection with Lugol's Iodine (VILI). Women randomized to the Pocket Colposcope arm will undergo Pocket-Assisted VIA (PA-VIA), green light imaging, and VILI using the Pocket Colposcope. Women in both arms will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
Women with a negative HPV test
Patients incapable of giving informed consent
Women with a history of cervical cancer
Pelvic exam concerning for cervical cancer or cervical infection

Primary Outcome Measures

Name	Time	Method
Percent of Exams With Lesions Identified	Baseline	The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.
Sensitivity	Baseline	Sensitivity of Pocket vs VIA
Specificity	Baseline	Specificity of Pocket vs VIA
Negative Predictive Value (NPV)	Baseline	Negative predictive value (NPV) of Pocket vs VIA
Positive Predictive Value (PPV)	Baseline	Positive predictive value (PPV) of Pocket vs VIA

Secondary Outcome Measures

Name	Time	Method
Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire	baseline	Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit.
Percent of Providers Who Reported Experiencing no Challenges During the Exam	baseline	Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'.
Percent of Participants Who Reported Experiencing Pain During Their Exam	Baseline	Participant perspective of the exam was assessed by asking "Did you experience any pain throughout your exam?"
Percent of Participants Who Expressed Confidence in Their Provider's Assessment	Baseline	Participant perspective of the exam was assessed by asking "How confident are you in the provider's assessment from today's visit?"
Percent of Participants Who Would Recommend the Exam to a Friend	Baseline	Participant perspective of the exam was assessed by asking "How likely would you recommend this medical exam to a friend?"