Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05723484
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-01-27
Brief Title:
Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplification Tests for Detection of Sexually Transmitted Infections and Bacterial Vaginosis
Sponsor:
Organization:
University of Cape Town
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
False
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITHOUT_DNA
Bio Spec Description:
Urine - Pregnancy test Finger prick blood - HIV testing Dacron vaginal swab-SWAB 1 - GIFT device Dacron vaginal swab- SWAB 2 - Cytokine ELISA Dacron vaginal swab- SWAB 3 - pH Dacron vaginal swab-SWAB 3 - Nugent score Copan flocked vaginal swab- SWAB 4 - STI NAAT Copan flocked vaginal swab- SWAB 5 - STI NAAT Copan flocked vaginal swab- SWAB 5 - Quantitative PCR for Lactobacilli Gardnerella vaginalis and Fannyhessea vaginae Semen NAATELISA Copan flocked vaginal swab-SWAB 6 and 7 - 16S rRNA sequencing
Enrollment Count:
675
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Cohort |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 92605 |
Who Masked List: