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Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing (SOVS-CTG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of California, San Francisco
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01849653
First received: April 24, 2013
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be compared to the result obtained with an SOVS collected in the clinic on multiple platforms (Direct Tube Sampling (DTS) / Panther / Tigris). The term "home-collected" is used to refer to any specimen that is not collected in a clinic, since there is no certainty that a specimen is collected "at home" or in a restroom in an office setting, etc. To compare the SOVS results to an FDA cleared predicate test with the collection of two clinician collected vaginal swabs.


Condition
Chlamydial Infection
Gonococcal Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing: Concurrence in Non-Clinical Settings vs. Clinical Settings

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Chlamydia trachomatis detected by nucleic acid amplification test in vaginal swabs [ Time Frame: 24 hrs (at clinic visit) ] [ Designated as safety issue: No ]
    AC2 testing on the DTS, Panther, and Tigris platforms for the presence or absence of Ct on "Home-collected" vs. "Clinic-collected" swab specimens, and clinician collected swabs.


Secondary Outcome Measures:
  • Neisseria gonorrhoeae detected by nucleic acid amplification test in vaginal swabs [ Time Frame: 24 hrs (at clinic visit) ] [ Designated as safety issue: No ]
    AC2 testing on the DTS, Panther, and Tigris platforms for the presence or absence of GC on "Home-collected" vs. "Clinic-collected" swab specimens, and clinician collected swabs.


Biospecimen Retention:   Samples With DNA

Residual vaginal swab specimens collected with the APTIMA® Vaginal Swab Specimen Collection Kit.


Estimated Enrollment: 3500
Study Start Date: August 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women - Upcoming routine clinic visit
This group of women will self-obtain vaginal swabs at home on the day of their medical appointment and bring the specimens to the clinic. Subjects will then self-obtain another set of vaginal swabs at the clinic. Clinician/nurse will obtain another set of vaginal swabs from the subject at the clinic.
Women - Recruited while at the clinic
This group of women will self-obtain vaginal swabs at the clinic. Clinician/nurse will obtain another set of vaginal swabs from the subject at the clinic. Within 24 hours of their clinic visit, subjects will self-obtain another set of vaginal swabs at their home and mail them to the laboratory.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This will be a multicenter trial involving approximately 3500 women ages 16-75 from different geographic areas in North America and from populations having different prevalences of Ct and GC. Women will be either healthy women having routine exams, or women being evaluated specifically for STDs (symptomatic and asymptomatic). Sites will include Family Planning, Ob/Gyn and STD clinics. The possibility of using a college student health clinic and a military clinic will be explored if it proves feasible to obtain a large enough number of participants during the project's planned duration.

Criteria

Inclusion Criteria:

  • Asymptomatic and symptomatic females ages 16-75
  • Subjects scheduled for visits or presenting at Family Planning, OB/Gyn, STD or other clinics requesting (or candidates for) routine screening for Ct/GC
  • Willing to provide informed consent (written per site institutional review board approval)

Exclusion Criteria:

  • Inability to provide informed consent
  • Inability or unwillingness to collect a specimen at home (and mail it)
  • On antibiotic therapy within the last 30 days
  • Clinical conditions, such as cervicitis or pelvic inflammatory disease that would indicate presumptive treatment
  • Contact to person with Ct or GC in need of epidemiologic treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849653

Contacts
Contact: Julius Schachter, PhD 415 824 5115 julius.schachter@ucsf.edu
Contact: Jeanne Moncada, MT 415 824 5117 jeanne.moncada@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Kohar Der Simonian, MD    415-206-3372    DerSimonianK@fcm.ucsf.edu   
Contact: Beth Brown, MA, MPA    415 514-1480    brownb@obgyn.ucsf.edu   
Principal Investigator: Julius Schachter, PhD         
Sponsors and Collaborators
University of California, San Francisco
University of Alabama at Birmingham
Investigators
Study Chair: Julius Schachter, PhD University of California, San Francisco
  More Information

Additional Information:
Publications:
Altman DG, Machin D, Bryant TN, Gardner MJ, (eds). Statistics with Confidence, 2nd ed. Bristol, UK: British Medical Journal; 2000.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01849653     History of Changes
Other Study ID Numbers: SOVS-CTG2013, HHSN266200400074C
Study First Received: April 24, 2013
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
vaginal swabs
diagnosis

Additional relevant MeSH terms:
Gonorrhea
Chlamydia Infections
Communicable Diseases
Infection
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial

ClinicalTrials.gov processed this record on November 25, 2014