1:1 Comparison of the Pocket Colposcope in Kenya

NCT ID: NCT04998318

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 434 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-28
• Study Completion Date: 2024-06-16

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.

Conditions

Cervical Cancer; HPV Infection; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Colposcopy

Intervention Type: PROCEDURE

VIA and VILI as previously described,

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.

Group Type: EXPERIMENTAL

Pocket Colposcope

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Standard of Care Colposcopy

VIA and VILI as previously described,

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan Huchko, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Kenya Medical Research Institute

Nairobi, , Kenya

Countries

Kenya

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00106169

Identifier Type: -

Identifier Source: org_study_id