1:1 Comparison of the Pocket Colposcope in Kenya

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

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

Study Overview

• Status: Completed
• Conditions: HIV Infections; Cervical Cancer; HPV Infection
• Intervention / Treatment: Procedure: Standard of Care Colposcopy; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 434
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya
    • Kenya Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 25 years old and < 65 years old
2. Sex: Female
3. Positive HPV test within past 6 months
4. HIV+ women

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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; VIA and VILI as previously described,
Experimental: Pocket Colposcope; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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?'.	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?"	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?"	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?"	Baseline

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Kenya Medical Research Institute
• Investigators: Principal Investigator: Megan Huchko, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): May 16, 2024
• Study Completion (Actual): June 16, 2024

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: colposcopy; Pap smear; cervical cancer screening, Pap smear, Colposcopy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Infections; Communicable Diseases; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: Pro00106169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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