Pocket Colposcopy Using CARE Algorithm

Duke University

Status: Enrolling

Conditions: HPV Infection; Cervical Cancer

Treatments: Device: Pocket Colposcope

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06458062

Pro00114753

1U01CA269192 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The Pocket colposcope has 510k FDA clearance and has been successfully used in ~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at four Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.

Full description

Women undergo Pocket-Assisted VIA (PA-VIA) and green light imaging using the Pocket Colposcope. Women 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. Once we have obtained enough images to develop the CARE algorithm, it will also be used to assist the provider in diagnosis.

This record previously reflected only Phase 1 of Aim 3 of the grant. Phase 1 of Aim 3 was originally included within NCT04998318. The details for Phase 2 of Aim 3 were added to this record in September 2025 after approval.

Enrollment: 1,079 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH)
2. Sex: Female
3. Positive HPV test within past 6 months

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 within the past 9 months
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
6. History of hysterectomy

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,079 participants in 1 patient group

Pocket Assisted Colposcopy

Experimental group

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. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. 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.

Treatment:

Device: Pocket Colposcope