Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing (SOVS-CTG)
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|ClinicalTrials.gov Identifier: NCT01849653|
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : June 3, 2016
University of California, San Francisco
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of California, San Francisco
No Study Results Posted on ClinicalTrials.gov for this Study
|Recruitment Status :||Completed|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Publications of Results:
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):231-9. doi: 10.1097/AOG.0b013e3182246a83.
Götz 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.
Cook RL, Østergaard 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. Epub 2007 Feb 14.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Kudrick JA, (DMID Clinical Agents Repository Contract: Fisher BioServices). Personal correspondence with NIH/NIAID staff. Germantown, MD; February 10, 2011.
Altman DG, Machin D, Bryant TN, Gardner MJ, (eds). Statistics with Confidence, 2nd ed. Bristol, UK: British Medical Journal; 2000.