Back to results1:1 Comparison of the Pocket Colposcope in Kenya
Primary Purpose
Cervical Cancer, HPV Infection, HIV Infections
Status
Recruiting
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Pocket Colposcope
Standard of Care Colposcopy
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer focused on measuring cervical cancer screening, Pap smear, Colposcopy, Pap smear, colposcopy
Eligibility Criteria
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
Sites / Locations
- Kenya Medical Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Pocket Colposcope
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of lesions identified by the pocket colposcope
Exam conducted via the pocket colposcope to identify abnormal lesions.
Percentage of lesions identified by the visual inspection
Exam conducted via visual inspection to identify abnormal lesions.
Secondary Outcome Measures
Percentage of Provider who identified possible obstacles as measured by surveys
Providers are given surveys to determine any obstacles to routine cervical cancer screening
Percentage of participants who identified possible obstacles as measured by surveys
Participants are given surveys to determine any obstacles to routine cervical cancer screening
Full Information
NCT ID
NCT04998318
First Posted
August 2, 2021
Last Updated
August 16, 2023
Sponsor
Duke University
Collaborators
Kenya Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04998318
Brief Title
1:1 Comparison of the Pocket Colposcope in Kenya
Official Title
Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Kenya Medical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, HPV Infection, HIV Infections
Keywords
cervical cancer screening, Pap smear, Colposcopy, Pap smear, colposcopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pocket Colposcope
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pocket Colposcope
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care Colposcopy
Intervention Description
VIA and VILI as previously described,
Primary Outcome Measure Information:
Title
Percentage of lesions identified by the pocket colposcope
Description
Exam conducted via the pocket colposcope to identify abnormal lesions.
Time Frame
Baseline
Title
Percentage of lesions identified by the visual inspection
Description
Exam conducted via visual inspection to identify abnormal lesions.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Percentage of Provider who identified possible obstacles as measured by surveys
Description
Providers are given surveys to determine any obstacles to routine cervical cancer screening
Time Frame
baseline
Title
Percentage of participants who identified possible obstacles as measured by surveys
Description
Participants are given surveys to determine any obstacles to routine cervical cancer screening
Time Frame
baseline
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Huchko, MD
Phone
919-684-8111
Email
megan.huchko@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Huchko, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kenya Medical Research Institute
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Bukusi, MD
Phone
+254 722205901
Email
ebukusi@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
1:1 Comparison of the Pocket Colposcope in Kenya
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