Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528184
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective of the study is to determine the extent that offering of self-sampling in addition to clinician-sampling Human Papillomavirus HPV DNA testing will increase detection of HPV DNA through an increase in uptake rates of cervical cancer screening as compared to offering clinician-sampling HPV DNA testing alone
The hypothesis is that offering additional self-sampling will increase the detection of high-risk HPV DNA by at least 77
The hypothesis is that offering additional self-sampling will increase the detection of high-risk HPV DNA by at least 77
Detailed Description:
This study is a pragmatic multi-center 11 randomized controlled trial designed to evaluate the impact of self-sampling HPV DNA testing on clinical outcomes and cost-effectiveness in cervical cancer screening The trial will compare 2 approaches to HPV DNA testing within public primary care settings
Participants in the intervention arm will first be offered a clinician-sampling HPV DNA test If they decline they will be offered the option of self-sampling HPV DNA test The control arm will follow the standard protocol of offering only the conventional clinician-sampling HPV DNA test reflecting the current standard of care in cervical cancer screening
This study seeks to provide robust evidence on whether self-sampling can improve clinical outcomes be cost-effective and be feasibility implemented in routine public primary healthcare settings The findings are expected to inform future guidelines and policies for cervical cancer screening programs
Participants in the intervention arm will first be offered a clinician-sampling HPV DNA test If they decline they will be offered the option of self-sampling HPV DNA test The control arm will follow the standard protocol of offering only the conventional clinician-sampling HPV DNA test reflecting the current standard of care in cervical cancer screening
This study seeks to provide robust evidence on whether self-sampling can improve clinical outcomes be cost-effective and be feasibility implemented in routine public primary healthcare settings The findings are expected to inform future guidelines and policies for cervical cancer screening programs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None