1:1 Comparison of the Pocket Colposcope in Kenya

Duke University434 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

434

Conditions

Cervical Cancer HPV Infection HIV Infections

Interventions

Pocket ColposcopeDEVICE

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.

Standard of Care ColposcopyPROCEDURE

VIA and VILI as previously described,

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Kenya Medical Research Institute

Nairobi, Kenya

Outcomes

Primary Outcomes

Percent of Exams With Lesions Identified

The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.

Time frame: Baseline

Sensitivity

Sensitivity of Pocket vs VIA

Time frame: Baseline

Specificity

Specificity of Pocket vs VIA

Time frame: Baseline

Negative Predictive Value (NPV)

Negative predictive value (NPV) of Pocket vs VIA

Time frame: Baseline

Positive Predictive Value (PPV)

Positive predictive value (PPV) of Pocket vs VIA

Time frame: Baseline

Secondary Outcomes

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

Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit.

Time frame: baseline

Percent of Providers Who Reported Experiencing no Challenges During the Exam

Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'.

Time frame: baseline

Percent of Participants Who Reported Experiencing Pain During Their Exam

Participant perspective of the exam was assessed by asking "Did you experience any pain throughout your exam?"

Data from ClinicalTrials.gov

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