Spots Global Cancer Trial Database for 1:1 Comparison of the Pocket Colposcope in Kenya

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Trial Identification

Brief Title: 1:1 Comparison of the Pocket Colposcope in Kenya

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

Study ID: NCT04998318

Conditions

Cervical Cancer

HPV Infection

HIV Infections

Interventions

Pocket Colposcope

Standard of Care Colposcopy

Study Description

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.