Healthy Clinical Trial
Official title:
A New Approach to Cervical Cancer Prevention in Kenya
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.
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).
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