1:1 Comparison of the Pocket Colposcope in Kenya

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04998318
• Other study ID #: Pro00106169
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: Megan Huchko, MD
• Phone: 919-684-8111
• Email: megan.huchko[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Communicable Diseases
• HIV Infections
• HPV Infection
• Infections
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

Device:
• 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.

Procedure:
• Standard of Care Colposcopy
VIA and VILI as previously described,

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of lesions identified by the pocket colposcope	Exam conducted via the pocket colposcope to identify abnormal lesions.	Baseline
Primary	Percentage of lesions identified by the visual inspection	Exam conducted via visual inspection to identify abnormal lesions.	Baseline
Secondary	Percentage of Provider who identified possible obstacles as measured by surveys	Providers are given surveys to determine any obstacles to routine cervical cancer screening	baseline
Secondary	Percentage of participants who identified possible obstacles as measured by surveys	Participants are given surveys to determine any obstacles to routine cervical cancer screening	baseline