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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
434
Both arms will receive treatment in order to prevent cervical cancer. However, the intervention using the pocket colposcope device will be used on half the enrolled subjects.
VIA and VILI as previously described,
Kenya Medical Research Institute
Nairobi, Kenya
Percent of Exams With Lesions Identified
The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.
Time frame: Baseline
Sensitivity
Sensitivity of Pocket vs VIA
Time frame: Baseline
Specificity
Specificity of Pocket vs VIA
Time frame: Baseline
Negative Predictive Value (NPV)
Negative predictive value (NPV) of Pocket vs VIA
Time frame: Baseline
Positive Predictive Value (PPV)
Positive predictive value (PPV) of Pocket vs VIA
Time frame: Baseline
Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire
Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit.
Time frame: baseline
Percent of Providers Who Reported Experiencing no Challenges During the Exam
Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'.
Time frame: baseline
Percent of Participants Who Reported Experiencing Pain During Their Exam
Participant perspective of the exam was assessed by asking "Did you experience any pain throughout your exam?"
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Time frame: Baseline
Percent of Participants Who Expressed Confidence in Their Provider's Assessment
Participant perspective of the exam was assessed by asking "How confident are you in the provider's assessment from today's visit?"
Time frame: Baseline
Percent of Participants Who Would Recommend the Exam to a Friend
Participant perspective of the exam was assessed by asking "How likely would you recommend this medical exam to a friend?"
Time frame: Baseline