Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing

NCT01849653 | Completed

• 2 other identifiers: SOVS-CTG2013HHSN266200400074C
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chlamydial Infection; Gonococcal Infection

Keywords

vaginal swabs; diagnosis

Outcome Measures

Primary Outcomes (1)

• Chlamydia trachomatis detected by nucleic acid amplification test in vaginal swabs

  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.

  24 hrs (at clinic visit)

Secondary Outcomes (1)

• Neisseria gonorrhoeae detected by nucleic acid amplification test in vaginal swabs

  24 hrs (at clinic visit)

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related Publications (22)

• Hobbs MM, van der Pol B, Totten P, Gaydos CA, Wald A, Warren T, Winer RL, Cook RL, Deal CD, Rogers ME, Schachter J, Holmes KK, Martin DH. From the NIH: proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexually transmitted infections. Sex Transm Dis. 2008 Jan;35(1):8-13. doi: 10.1097/OLQ.0b013e31815d968d.

  PMID: 18157061 BACKGROUND

• Martin DH, Cammarata C. Potential causes of decreased sensitivity of the Abbott ligase chain reaction (LCR) assay for Chlamydia trachomatis (Ct) in urine specimens. 13th International Society for Sexually Transmitted Diseases Research (ISSTDR). Denver, CO; 1999.

  BACKGROUND

• Kudrick JA, (DMID Clinical Agents Repository Contract: Fisher BioServices). Personal correspondence with NIH/NIAID staff. Germantown, MD; February 10, 2011.

  BACKGROUND

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

  BACKGROUND

• Shafer MA, Pantell RH, Schachter J. Is the routine pelvic examination needed with the advent of urine-based screening for sexually transmitted diseases? Arch Pediatr Adolesc Med. 1999 Feb;153(2):119-25. doi: 10.1001/archpedi.153.2.119.

  PMID: 9988241 BACKGROUND

• Xu F, Stoner BP, Taylor SN, Mena L, Tian LH, Papp J, Hutchins K, Martin DH, Markowitz LE. Use of home-obtained vaginal swabs to facilitate rescreening for Chlamydia trachomatis infections: two randomized controlled trials. Obstet Gynecol. 2011 Aug;118(2 Pt 1):231-239. doi: 10.1097/AOG.0b013e3182246a83.

  PMID: 21775837 RESULT

• Gotz HM, van den Broek IV, Hoebe CJ, Brouwers EE, Pars LL, Fennema JS, Koekenbier RH, van Ravesteijn S, Op de Coul EL, van Bergen J. High yield of reinfections by home-based automatic rescreening of Chlamydia positives in a large-scale register-based screening programme and determinants of repeat infections. Sex Transm Infect. 2013 Feb;89(1):63-9. doi: 10.1136/sextrans-2011-050455. Epub 2012 Jun 23.

  PMID: 22728910 RESULT

• Cook RL, Ostergaard L, Hillier SL, Murray PJ, Chang CC, Comer DM, Ness RB; DAISY study team. Home screening for sexually transmitted diseases in high-risk young women: randomised controlled trial. Sex Transm Infect. 2007 Jul;83(4):286-91. doi: 10.1136/sti.2006.023762. Epub 2007 Feb 14.

  PMID: 17301105 RESULT

• Gaydos CA, Barnes M, Aumakhan B, Quinn N, Wright C, Agreda P, Whittle P, Hogan T. Chlamydia trachomatis age-specific prevalence in women who used an internet-based self-screening program compared to women who were screened in family planning clinics. Sex Transm Dis. 2011 Feb;38(2):74-8. doi: 10.1097/OLQ.0b013e3182039d7f.

  PMID: 21173720 RESULT

• Schachter J, Chow JM, Howard H, Bolan G, Moncada J. Detection of Chlamydia trachomatis by nucleic acid amplification testing: our evaluation suggests that CDC-recommended approaches for confirmatory testing are ill-advised. J Clin Microbiol. 2006 Jul;44(7):2512-7. doi: 10.1128/JCM.02620-05.

  PMID: 16825373 RESULT

• Lee HH, Chernesky MA, Schachter J, Burczak JD, Andrews WW, Muldoon S, Leckie G, Stamm WE. Diagnosis of Chlamydia trachomatis genitourinary infection in women by ligase chain reaction assay of urine. Lancet. 1995 Jan 28;345(8944):213-6. doi: 10.1016/s0140-6736(95)90221-x.

  PMID: 7823713 RESULT

• Hook EW 3rd, Smith K, Mullen C, Stephens J, Rinehardt L, Pate MS, Lee HH. Diagnosis of genitourinary Chlamydia trachomatis infections by using the ligase chain reaction on patient-obtained vaginal swabs. J Clin Microbiol. 1997 Aug;35(8):2133-5. doi: 10.1128/jcm.35.8.2133-2135.1997.

  PMID: 9230397 RESULT

• Stary A, Najim B, Lee HH. Vulval swabs as alternative specimens for ligase chain reaction detection of genital chlamydial infection in women. J Clin Microbiol. 1997 Apr;35(4):836-8. doi: 10.1128/jcm.35.4.836-838.1997.

  PMID: 9157137 RESULT

• Schachter J, McCormack WM, Chernesky MA, Martin DH, Van Der Pol B, Rice PA, Hook EW 3rd, Stamm WE, Quinn TC, Chow JM. Vaginal swabs are appropriate specimens for diagnosis of genital tract infection with Chlamydia trachomatis. J Clin Microbiol. 2003 Aug;41(8):3784-9. doi: 10.1128/JCM.41.8.3784-3789.2003.

  PMID: 12904390 RESULT

• Schachter J, Chernesky MA, Willis DE, Fine PM, Martin DH, Fuller D, Jordan JA, Janda W, Hook EW 3rd. Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections. Sex Transm Dis. 2005 Dec;32(12):725-8. doi: 10.1097/01.olq.0000190092.59482.96.

  PMID: 16314767 RESULT

• Chernesky MA, Hook EW 3rd, Martin DH, Lane J, Johnson R, Jordan JA, Fuller D, Willis DE, Fine PM, Janda WM, Schachter J. Women find it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia trachomatis or Neisseria gonorrhoeae infections. Sex Transm Dis. 2005 Dec;32(12):729-33. doi: 10.1097/01.olq.0000190057.61633.8d.

  PMID: 16314768 RESULT

• Shafer MA, Moncada J, Boyer CB, Betsinger K, Flinn SD, Schachter J. Comparing first-void urine specimens, self-collected vaginal swabs, and endocervical specimens to detect Chlamydia trachomatis and Neisseria gonorrhoeae by a nucleic acid amplification test. J Clin Microbiol. 2003 Sep;41(9):4395-9. doi: 10.1128/JCM.41.9.4395-4399.2003.

  PMID: 12958275 RESULT

• Macmillan S, McKenzie H, Templeton A. Parallel observation of four methods for screening women under 25 years of age for genital infection with Chlamydia trachomatis. Eur J Obstet Gynecol Reprod Biol. 2003 Mar 26;107(1):68-73. doi: 10.1016/s0301-2115(02)00266-x.

  PMID: 12593898 RESULT

• Oakeshott P, Hay P, Hay S, Steinke F, Rink E, Thomas B, Oakeley P, Kerry S. Detection of Chlamydia trachomatis infection in early pregnancy using self-administered vaginal swabs and first pass urines: a cross-sectional community-based survey. Br J Gen Pract. 2002 Oct;52(483):830-2.

  PMID: 12392124 RESULT

• Smith K, Harrington K, Wingood G, Oh MK, Hook EW 3rd, DiClemente RJ. Self-obtained vaginal swabs for diagnosis of treatable sexually transmitted diseases in adolescent girls. Arch Pediatr Adolesc Med. 2001 Jun;155(6):676-9. doi: 10.1001/archpedi.155.6.676.

  PMID: 11386956 RESULT

• Gaydos CA, Crotchfelt KA, Shah N, Tennant M, Quinn TC, Gaydos JC, McKee KT Jr, Rompalo AM. Evaluation of dry and wet transported intravaginal swabs in detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in female soldiers by PCR. J Clin Microbiol. 2002 Mar;40(3):758-61. doi: 10.1128/JCM.40.3.758-761.2002.

  PMID: 11880389 RESULT

• Chernesky M, Jang D, Luinstra K, Chong S, Smieja M, Cai W, Hayhoe B, Portillo E, Macritchie C, Main C, Ewert R. High analytical sensitivity and low rates of inhibition may contribute to detection of Chlamydia trachomatis in significantly more women by the APTIMA Combo 2 assay. J Clin Microbiol. 2006 Feb;44(2):400-5. doi: 10.1128/JCM.44.2.400-405.2006.

  PMID: 16455891 RESULT

Related Links

• Association of Public Health Laboratories (APHL). Laboratory Diagnostic Testing for Chlamydia trachomatis and Neisseria gonorrhoeae. Expert Consultation Meeting Summary Report, January 13-15, 2009

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Chlamydia Infections; Gonorrhea; Disease

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julius Schachter, PhD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: May 8, 2013
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

US (1)