1:1 Comparison of the Pocket Colposcope in Kenya

NCT04998318 | Completed Results FDA Device

• 1 other identifier: Pro00106169
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Cancer; HPV Infection; HIV Infections

Keywords

cervical cancer screening, Pap smear, Colposcopy; Pap smear; colposcopy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire

  baseline

• Percent of Providers Who Reported Experiencing no Challenges During the Exam

  baseline

• Percent of Participants Who Reported Experiencing Pain During Their Exam

  Baseline

• Percent of Participants Who Expressed Confidence in Their Provider's Assessment

  Baseline

• Percent of Participants Who Would Recommend the Exam to a Friend

  Baseline

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Pocket Colposcope

EXPERIMENTAL

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

Interventions

Pocket Colposcope DEVICE

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.

Pocket Colposcope

Standard of Care Colposcopy PROCEDURE

VIA and VILI as previously described,

Standard of Care

Eligibility Criteria

• Age: 25 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 25 years old and \< 65 years old
• Sex: Female
• Positive HPV test within past 6 months
• HIV+ women

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; HIV Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Megan Huchko, MD, MPH
• Organization: Duke University Medical Center

megan.huchko@duke.edu

(919) 684-8111

Study Officials

• Megan Huchko, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: November 28, 2022
• Primary Completion: May 16, 2024
• Study Completion: June 16, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)