A New Approach to Cervical Cancer Prevention in Kenya
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|ClinicalTrials.gov Identifier: NCT03942705|
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : July 10, 2019
|Condition or disease|
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).
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||A New Approach to Cervical Cancer Prevention in Kenya|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Women living in western Kenya will be asked to complete a self collected vaginal sample for HPV DNA screening and asked to undergo a second screening by VIA. As per Kenyan standard of care, vaccination against HPV will be offered to children/grandchildren (boys and girls) of women, and to the women themselves if age 26 or younger. The second vaccine dose (for children ages 9 through 14) and third doses (for children and adult women ages 15 through 26) will be administered at subsequent visits. There will be no requirement for HPV vaccination (of children or mothers up to 26 years of age) for participation in the study. Results of the screening will be returned to participants and they will be referred to receive standard care as applicable.
- Percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing. [ Time Frame: anytime after informed consent up to 2 years ]
- Percentage of women who attend clinic after providing self-collected vaginal swabs [ Time Frame: any time after completion of self-collected vaginal swab (up to 2 years) ]
- HPV DNA vaginal swab testing results [ Time Frame: 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 [ Time Frame: any time after VIA is performed, up to 2 years ]Results reported as abnormal or normal
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942705
|Contact: Darron Brown, MD, MPHfirstname.lastname@example.org|
|Contact: Elkanah Omenge, MD||011-254-72-260-9132||BWORANGO2000@YAHOO.COM|
|Moi University||Not yet recruiting|
|Contact: Elkanah Omenge, MD 011-254-72-260-9132|
|Principal Investigator:||Darron Brown, MD||Indiana University|