Clinical trial NCT03942705: A New Approach to Cervical Cancer Prevention in Kenya
Official title: A New Approach to Cervical Cancer Prevention in Kenya
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: human papillomavirus (HPV)
cervical cancer
prevention
Kenya
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Academic Model Providing Access to Healthcare (AMPATH)
First posted: 2019-05-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.
timeFrame: anytime after informed consent up to 2 years
measure: Percentage of women who attend clinic after providing self-collected vaginal swabs
timeFrame: any time after completion of self-collected vaginal swab (up to 2 years)
Secondary outcomes:
measure: HPV DNA vaginal swab testing results
timeFrame: any time after after self-collected vaginal swab, up to 2 years
measure: Visual inspection with acetic acid (VIA) testing results
timeFrame: any time after VIA is performed, up to 2 years
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi University
Study officials:
affiliation: Indiana University
name: Darron Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: