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Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM

This study has been completed.
Information provided by:
University of California, San Francisco Identifier:
First received: September 15, 2005
Last updated: April 13, 2011
Last verified: April 2011
Julius Schachter, PhD, from the Department of Laboratory Medicine at UCSF, and Jeffrey Klausner, MD, from the Department of Public Health, are conducting a study to evaluate a type of test (nucleic acid amplification test) for the detection of two sexually transmitted diseases, Chlamydia trachomatis and Neisseria gonorrhoeae, in men who have sex with men (MSM), using urine samples and swabs taken from the throat (pharynx), tip of penis (glans), and rectum. The use of nucleic acid amplification tests on these swabs is experimental, which means that the use of the tests for this purpose have not been approved by the Food & Drug Administration.

Sexually Transmitted Diseases

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Positive nucleic acid amplification result for Chlamydia trachomatis or Neisseria gonorrhoeae. [ Time Frame: At enrollment/screening ]

Biospecimen Retention:   Samples With DNA
self-collected glans swab; clinician-collected rectal and pharyngeal swabs

Enrollment: 907
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men who have sex with men (MSM) voluntarily presenting at the City STD clinic.

Inclusion Criteria:

  • A subject must be a man who has sex with men (MSM). Subjects must provide verbal consent, must be able to submit all required specimens and must not have urinated within 1 hr prior to providing a study urine specimen.

Exclusion Criteria:

  • Subjects are excluded if they do not have sex with men, refuse to give verbal consent, are unable to provide all required specimens and minimum specimen volume, have been on antibiotic therapy within the last 21 days, have urinated within 1 hr prior to submitting study specimens, and have already been evaluated as part of this trial. Subjects will be excluded if specimens are mishandled or inappropriately stored.
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Please refer to this study by its identifier: NCT00187902

United States, California
City Clinic
San Francisco, California, United States, 94103
Sponsors and Collaborators
University of California, San Francisco
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
  More Information

Moncada J, Chernesky M, McCormack W, Schachter J. Evaluation of the Gen-Probe Amplified Chlamydia trachomatis Assay on self-collected vaginal swabs from asymptomatic young females. In: Stephens RS, Byrne GI, Christiansen G, Clarke IN, Grayston JT, Rank RG, et al., editors. Chlamydial Infections: Proceedings of the Ninth International Symposium on Human Chlamydial Infection. San Francisco: International Chlamydia Symposium, 1998:595-8.

Responsible Party: Julius Schachter, PhD, Univ of CA, San Francisco Identifier: NCT00187902     History of Changes
Other Study ID Numbers: H1079-26791-01
Study First Received: September 15, 2005
Last Updated: April 13, 2011

Keywords provided by University of California, San Francisco:
Sexually Transmitted Diseases
Chlamydia trachomatis
Neisseria gonorrhoeae

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Genital Diseases, Male
Genital Diseases, Female
Virus Diseases
Neisseriaceae Infections processed this record on May 25, 2017