1:1 Comparison of the Pocket Colposcope in Kenya

Study Overview
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Brief Summary
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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
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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.

Official Title
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Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya

Conditions
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Cervical Cancer, HPV Infection, HIV Infections

Intervention / Treatment
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* Device: Pocket Colposcope
* Procedure: Standard of Care Colposcopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 25 years old and < 65 years old Sex: Female Positive HPV test within past 6 months HIV+ women 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. Visual Inspection with Lugol's Iodine (VILI): After imaging with Acetic acid, Lugol's iodine will be applied using a fox swab noting any yellow or non-staining areas. Lesion location(s) will be noted on a clock-face diagram and used to direct biopsy if a lesion is present or random biopsies will be obtained from two quadrants in the absence of a visible lesion. | Procedure: Standard of Care Colposcopy<br>* VIA and VILI as previously described,<br>|
| Experimental: Pocket Colposcope<br>Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. Pocket-Assisted Visual Inspection with Lugol's Iodine (PA-VILI): After imaging with AA, Lugol's iodine will be applied using a fox swab noting any yellow or non-staining areas. Images will be acquired. A biopsy will be obtained using the pocket. Random biopsies will be obtained from 2 quadrants in the absence of a visible lesion. | Device: Pocket Colposcope<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of lesions identified by the pocket colposcope | Exam conducted via the pocket colposcope to identify abnormal lesions. | Baseline | 
| Percentage of lesions identified by the visual inspection | Exam conducted via visual inspection to identify abnormal lesions. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Provider who identified possible obstacles as measured by surveys | Providers are given surveys to determine any obstacles to routine cervical cancer screening | baseline | 
| Percentage of participants who identified possible obstacles as measured by surveys | Participants are given surveys to determine any obstacles to routine cervical cancer screening | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer screening, Pap smear, Colposcopy, Pap smear, colposcopy