Cervical Cancer, HPV Infection
Conditions
Keywords
HPV testing, colposcopy, cervical cancer screening
Brief summary
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.
Detailed 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.
Interventions
DEVICEPocket Colposcope
Each patient will receive treatment in order to prevent cervical cancer
Sponsors
Kenya Medical Research Institute
National Cancer Institute (NCI)
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the Pocket CARE in detecting pre-cancer | Day of imaging (Day 1) | Sensitivity will be reported as a percentage |
| Specificity of the Pocket CARE in detecting pre-cancer | Day of imaging (Day 1) | Specificity will be reported as a percentage |
| Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer | Day of imaging (Day 1) | PPV will be reported as a percentage |
| Negative Predictive Value (NPV) of the Pocket CARE in detecting pre-cancer | Day of imaging (Day 1) | NPV will be reported as a percentage |
Countries
Kenya
Contacts
Primary ContactMegan Huchko, MD
Outcome results
None listed