Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03931083
Status:
UNKNOWN
Last Update Posted:
2020-11-03
First Post:
2019-04-15
Brief Title:
Screening Test Accuracy of Gynocular HR-HPV Testing VIA for Detection of Cervical Neoplastic Lesions in Women Living With HIV
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Screening Test Accuracy of a Gynocular HR-HPV Testing and VIA for Detection of Cervical Intraepithelial Neoplasia Grade Two and Above in Women Living With HIV in Lusaka Zambia
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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:
Cervical cancer in HIV-positive women is largely preventable through regular screening The World Health Organization WHO recommends cervical screening for HIV-positive women every three years Currently the least costly method for screening and the most viable option for many countries is visual inspection after application of acetic acid VIA Alternative testing methods are HPV testing and assessment with a portable magnification device The investigators plan to assess and compare the screening test accuracy of these screening tests in women living with HIV All women will receive histopathology reference standard
Detailed Description:
The simplest and least costly method for cervical cancer screening is visual inspection after application of acetic acid VIA However the ability of this screening method to correctly identify precancerous lesions sensitivity and women free from these lesions specificity is limited The investigators aim to identify alternative screening methods which maximize sensitivity and specificity particularly in HIV-infected women in receiving care in Southern Africa The investigators will evaluate the screening test accuracy of a new portable magnification device the Gynocular with Swede score assessment in women who are HIV-positive and eligible for cervical cancer screening The investigators will assess the accuracy of the device when used as a stand alone test as well as when used subsequent to positive VIA or HPV tests The investigators will make comparisons with current screening practices VIA alone as well as recommended screening practices HPV testing The investigators will enrol 450 HIV-positive women receiving care for HIVAIDS at the Centre for Infectious Disease Research in Zambia in Lusaka Zambia Consenting women will be screened with VIA HPV testing and visual assessment with Gynocular All women undergo biopsy reference standard and receive treatment as indicated and in accordance with national guidelines
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AI069924 | NIH | ESTHER Switzerland | httpsreporternihgovquickSearchU01AI069924 |
| KFS-4156-02-2017 | OTHER_GRANT | None | None |
| Esther17G9 | OTHER_GRANT | None | None |