Healthy Clinical Trial
Official title:
A New Approach to Cervical Cancer Prevention in Kenya
NCT number | NCT03942705 |
Other study ID # | 1712513308 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 7, 2019 |
Est. completion date | May 31, 2021 |
Verified date | June 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 31, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 55 Years |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Moi University | Eldoret |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Academic Model Providing Access to Healthcare (AMPATH), Merck Sharp & Dohme LLC |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 | HPV DNA vaginal swab testing results | analyzed for the human reference gene (specimen adequacy), HPV 16/18, or any of 12 oncogenic HPV types. | any time after after self-collected vaginal swab, up to 2 years | |
Secondary | Visual inspection with acetic acid (VIA) testing results | Results reported as abnormal or normal | any time after VIA is performed, up to 2 years |
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