Ignite Creation Date:
2024-05-06 @ 1:41 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04092257
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2019-09-13
Brief Title:
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for HIV-infected Women in Lilongwe Malawi
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 assess completion and performance of the following novel invasive cervical cancer ICC screen-and-treat algorithm among 625 HIV-positive women in Lilongwe Malawi 1 rapid testing of self-collected vaginal brush for primary high risk hr-human papillomavirus HPV 2 same-day visual inspection with acetic acid VIA for women who are hr-HPV positive and 3 thermocoagulation for VIA positiveablation-eligible by cervical colposcopy women
Detailed Description:
This is a single arm prospective study of 625 HIV-positive women attending ART clinics in Lilongwe Malawi The primary objectives of this study are to assess completion of a novel ICC screen-and-treat strategy among HIV-positive women in Lilongwe Malawi using self-collected vaginal brush for hr-HPV testing followed by same-day VIA and thermocoagulation for HPV-positiveVIA-positiveablation-eligible by colposcopy women and to determine the 24-week efficacy of thermocoagulation among HIV-positive women with CIN23 The secondary objective will be to evaluate the performance of the ICC screen-and-treat strategy by estimating overtreatment for women who are HPV-positiveVIA-positiveablation-eligible and undertreatment among HPV-positiveVIA-negative women
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA236770 | NIH | None | None |
| AID-OAA-A-11-00012 | OTHER_GRANT | USAIDNAS | httpsreporternihgovquickSearchR21CA236770 |