Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-09 @ 4:50 PM
Study NCT ID:
NCT03942705
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2019-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Approach to Cervical Cancer Prevention in Kenya
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
A New Approach to Cervical Cancer Prevention in Kenya
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: