A New Approach to Cervical Cancer Prevention in Kenya

Completed

• Conditions: Healthy

• Registration Number: NCT03942705
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to determine if the human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care.

Detailed Description

The purpose of this study is to test the hypothesis that effective cervical cancer screening can be performed in a high percentage of women, using HPV DNA of self-collected vaginal samples, provided by women attending either chamas (community groups) or in their own homes. HPV DNA testing will be used to triage women for a secondary screen by visual inspection with acetic acid (VIA) in a local clinic. The investigators will determine if HPV DNA testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care. In addition, women will bring their children to be vaccinated against HPV in these community meetings, using the standard of care for the approved HPV vaccine available in Kenya.

The investigators will test this approach by completing the following Specific Aims:

Specific Aim 1: Determine the percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.

Specific Aim 2. Following HPV DNA screening using self-collected swabs, determine the percentage of these women who will attend the local clinic.

Specific Aim 3. Evaluate the statistical correlation between HPV DNA testing of self-collected vaginal swabs and VIA (as all women in this pilot study will undergo VIA).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Study Start: 2019-10-07
• Primary Completion: 2021-02-28
• Study Completion: 2021-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Women who live in Kenya who are between the ages of 30 and 55, are willing to provide a self collected vaginal swab and willing to travel to the local clinic for a VIA

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Exclusion Criteria

1. current pregnancy, inability to consent due to mental or physical disability, or a medical illness that has rendered the patient unable to understand consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.	anytime after informed consent up to 2 years
Percentage of women who attend clinic after providing self-collected vaginal swabs	any time after completion of self-collected vaginal swab (up to 2 years)

Secondary Outcome Measures

Name	Time	Method
HPV DNA vaginal swab testing results	any time after after self-collected vaginal swab, up to 2 years	analyzed for the human reference gene (specimen adequacy), HPV 16/18, or any of 12 oncogenic HPV types.
Visual inspection with acetic acid (VIA) testing results	any time after VIA is performed, up to 2 years	Results reported as abnormal or normal

Trial Locations

Locations (1)

Moi University; 🇰🇪 Eldoret, Kenya