A New Approach to Cervical Cancer Prevention in Kenya

NCT ID: NCT03942705

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2021-05-31

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).

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Academic Model Providing Access to Healthcare (AMPATH)

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Darron Brown MD, MPH

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darron Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Moi University

Eldoret, , Kenya

Countries

Kenya

Other Identifiers

1712513308

Identifier Type: -

Identifier Source: org_study_id