A New Approach to Cervical Cancer Prevention in Kenya

Healthy Clinical Trial

Official title:

A New Approach to Cervical Cancer Prevention in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942705
• Other study ID #: 1712513308
• Status: Completed
• Start date: October 7, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Kenya	Moi University	Eldoret

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Academic Model Providing Access to Healthcare (AMPATH), Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Visual inspection with acetic acid (VIA) testing results	Results reported as abnormal or normal	any time after VIA is performed, up to 2 years