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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
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Academic Model Providing Access to Healthcare (AMPATH)
Information provided by (Responsible Party):
Darron Brown MD, MPH, 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.

Condition or disease
Healthy

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).


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort
Kenyan Women
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.



Primary Outcome Measures :
  1. 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 ]
  2. 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) ]

Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Kenyan women between the ages of 18 and 60 who are willing to provide a self-collected vaginal swabs and willing to travel to the local clinic for VIA.
Criteria

Inclusion Criteria:

  • Women who live in Kenya who are between the ages of 18 and 60, are willing to provide a self collected vaginal swab and willing to travel to the local clinic for a VIA

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942705


Contacts
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Contact: Darron Brown, MD, MPH 317-274-1425 darbrow@iu.edu
Contact: Elkanah Omenge, MD 011-254-72-260-9132 BWORANGO2000@YAHOO.COM

Locations
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Kenya
Moi University Not yet recruiting
Eldoret, Kenya
Contact: Elkanah Omenge, MD    011-254-72-260-9132      
Sponsors and Collaborators
Indiana University
Merck Sharp & Dohme Corp.
Academic Model Providing Access to Healthcare (AMPATH)
Investigators
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Principal Investigator: Darron Brown, MD Indiana University

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Responsible Party: Darron Brown MD, MPH, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03942705     History of Changes
Other Study ID Numbers: 1712513308
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Darron Brown MD, MPH, Indiana University:
human papillomavirus (HPV)
cervical cancer
prevention
Kenya
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female