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.

Study Overview

• Status: Completed
• Conditions: 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).

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya
    • Moi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.	anytime after informed consent up to 2 years
Percentage of women who attend clinic after providing self-collected vaginal swabs	any time after completion of self-collected vaginal swab (up to 2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV DNA vaginal swab testing results	analyzed for the human reference gene (specimen adequacy), HPV 16/18, or any of 12 oncogenic HPV types.	any time after after self-collected vaginal swab, up to 2 years
Visual inspection with acetic acid (VIA) testing results	Results reported as abnormal or normal	any time after VIA is performed, up to 2 years

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Merck Sharp & Dohme LLC; Academic Model Providing Access to Healthcare (AMPATH)
• Investigators: Principal Investigator: Darron Brown, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Kenya; prevention; cervical cancer; human papillomavirus (HPV)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: 1712513308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be made available after deidentification. Other documents including study protocol, statistical analysis plan, informed consent form, case study reports, will also be available. These documents will be available beginning three months after publication, and will end 12 months following publication. Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to darbrow@iu.edu. To gain access, data requesters will need to sign a data access agreement.
• IPD Sharing Time Frame: 3 to 12 months
• IPD Sharing Access Criteria: Data will be available to researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No