Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Prospective Evaluation of Self-Testing to Increase Screening PRESTIS AsianAsian American Women Supplement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among MinorityUnderserved Women in an Integrated Safety Net Healthcare System AsianAsian American Women
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible andor unacceptable to many women and persons with a cervix This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus HPV can cost-effectively increase screening participation among underserved minority women in a safety-net health system
Detailed Description:
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible andor unacceptable to many women and persons with a cervix Using mailed self-sampling kits to test for high-risk human papillomavirus HPV the virus that causes cervical cancer may overcome multiple barriers to clinic-based screening The parent study NCT03898167 is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system The three strategies that will be evaluated are 1 telephone recall 2 telephone recall with mailed self-sample HPV testing kits and 3 telephone recall with mailed self-sample HPV testing kits and patient navigation A supplemental accrual of AsianAsian American persons target n240 was added to increase representation of this subpopulation in the parent trial
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