Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM
Sexually Transmitted Diseases
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM|
- Positive nucleic acid amplification result for Chlamydia trachomatis or Neisseria gonorrhoeae. [ Time Frame: At enrollment/screening ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
For all subjects enrolled in the study, the following clinical data information will be obtained: 1) reason for exam, 2) subject's signs and symptoms and 3) clinical assessment.
For each subject enrolled in the study, three clinician-collected pharyngeal, four rectal swabs (three clinician-collected, 1 self-collected) specimens, one glans swab (self-collected) and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician collected swabs will be randomized.
Three pharyngeal swabs will be tested for: 1) CT/NG NAAT (TMA) at DPH, 2) NG culture at DPH and 3) NAATs for CT/NG (TMA, SDA) and CT culture at UCSF. Four rectal swabs will be tested for: 1) CT/NG NAAT (TMA) at DPH, 2) NG culture at DPH and 3) NAATs for CT/NG on Clinician- and self-collected rectal swab (TMA, SDA) and CT culture at UCSF. Self-collected glans swab and the FCU will be tested by NAATs for CT/NG (TMA, SDA) at UCSF. All NAAT specimens collected in a universal NAAT transport medium. After specimen processing, samples will be frozen at -70 C for discrepant analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187902
|United States, California|
|San Francisco, California, United States, 94103|
|Principal Investigator:||Julius Schachter, PhD||University of California, San Francisco|
|Principal Investigator:||Jeffrey D Klausner, MD, MPH||Department of Public Health, San Francisco, CA USA|