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Using Self-Collected Specimens to Improve and Extend Delivery of Chlamydia Screening: A Roundtable Discussion Charlotte A. Gaydos, MS, DrPH Professor Division of Infectious Diseases Johns Hopkins University National Chlamydia Coalition Washington, DC December 3-4, 2009
Description and Purpose ,[object Object],[object Object]
Background ,[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
Male Diagram Female Diagram
Noninvasive Screening for STDS Advantages  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Relative Comparison of Sensitivity of  Various Types of Tests for Detection of  Chlamydia or Gonorrhea   *Nucleic Acid Amplification Test   NAAT*     Signal  Amplification Test   Direct Probe Test   Enzyme Immunoassay Sensitivity Range/Sample 1  10  10 2  10 3   10 4   10 5   10 6   10 7   10 8 Number/  organisms per sample
New Specimen Types for Amplification Technologies for STD Diagnosis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Background Chlamydia load at matched anatomic sites Michel et al. JCM 2007;45:1395-1402
Four-Year Study of Urine-Based Screening of Female Army Recruits in the U.S. ,[object Object],[object Object],[object Object],Gaydos et al. STD 30:539-544, 2003
16.0% 5.4% 7.9% 10.4% 4.1% Female U.S. Army Recruits:   RESULTS  7.9% Gaydos et al. STD 30:539-544, 2003 Mean Age:   20.6 years.  OR 2.8 (proportion <25 yr  = 85.8%) 1996:  8.51%  1997:  9.68% 1998:  9.90%  1999:  9.92%  p = 0.018, using 1996 as referent
South: n = 10,963 (12.3%) Northeast:  n = 3,746 (7.5%) Midwest:  n = 4,128 (7.3%) West:  n = 3,779 (5.8%) Territories:  n =391 (9.5.%) Female U.S. Army Recruits: 1996-1999 Chlamydia Prevalence, by urine LCR (n=23,007)  CDC Reporting Region: Northeast, South, Midwest, West, Territories 3 individuals missing region assignment.
Chlamydia or Gonorrhea (13.6%) ED Mehta SD et al.  Sex Transm Dis  2001;28:33 22% >1 sex partner in the past 90 days; 37% male, vol rate 77%; 28% new sex partner in the past 90 days; 76% of infections were undetected by clinicians at  initial ED visit
Vaginal Swabs Are Appropriate  Specimens for  Diagnosis of Genital Tract Infection with  C. trachomatis Schachter et al. JCM 2003;41:3784-3789 NAAT sensitivity: Vaginal Swabs 93% Cervical Swabs 91% FVU 80.6% Culture Sensitivity 83.5% Specificities All Specimens >99% GenProbe APTIMA COMBO2 now FDA cleared for vaginal swabs
Patients’ First  Preference for  Sample Type  ,[object Object],[object Object]
Assessment of ease of use of vaginal swabs  Most Women reported that vaginal swabs were “easy” to collect!
Preference and Accuracy of  Self-administered Vaginal Swabs (SAS) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],*Hsieh et al. STD 2003;30:769-773;  ** Newman et al. STD 2003;30:306-309
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Populations and Venues  Where   Self Sampling Has Been Used ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Non-invasive Sampling Methods in Epidemiology Studies Summary:  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
www.iwantthekit.org
 
Female Questionnaire Results: Preference for Sample Type  (N=1165) Pelvic 20.7% Urine 7.6% Vaginal or Urine 11.5% Self Vaginal 48.8% Other Combo 11.4%
Female Questionnaire Results: Self Collection 90.9% 94.5% N = 1169 N = 1139
Female Questionnaire Results Vaginal Collection  96.7% 98.4% 91.7% N = 1114 N = 1113 N =1093
Female Questionnaire Results:  Preference for Receiving Results  (N=1179) 35.5% 9.8% 32.0% 32.7% 32.7%
RESULTS- Use of the Female Kit Requested by Internet email:   97.1%, Phone: 2.9% 31.8 % retuned requested kits total (40.1% 2008) ,[object Object],[object Object],[object Object],[object Object],[object Object]
RESULTS- Use of the Female Kit  (N=1199) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Are users from high risk groups? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Female CT Prevalence: Results by Age  (N = 1191*) 11.1% Infected 6.8% Infected 15.3% Infected *12 did not report age. There were 9 women 14 yr old, all were chlamydia negative 1.2% Infected
Results: Socio-Economic  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CONCLUSIONS: Female Kit Use ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Remaining Policy & Public Health Issues ,[object Object],[object Object],[object Object],[object Object],[object Object]
Points for Discussion ,[object Object],[object Object],[object Object],[object Object],[object Object]
Points for Discussion ,[object Object],[object Object],[object Object],[object Object]
 
 
Male Questionnaire Results Home collection (N = 501) Swab 89.8% 94.0% 91.4% Urine 95.3% No swab: 8; No urine 2
Male Questionnaire Results Preference for Sample Type  62.7% 62.4% 24.8% More than one answer possible
Age category Prevalence of STIs in Males by Age Category 11.1% 39.8% 22.1% 27.0%
Results – Behavioral – Males  N = 501   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Acknowledgements Shua Chai, MD, MPH Mathilda Barnes, BS Bulbul Aumakhan, MD, PhD Mary Jett-Goheen, BS Nicole Quinn, BS Patricia Agreda, MS Pamela Whittle, BS Terry Hogan, MPH

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Charlotte Gaydos: Using Self-Collected Specimens to Improve and Extend Delivery of Chlamydia Screening

  • 1. Using Self-Collected Specimens to Improve and Extend Delivery of Chlamydia Screening: A Roundtable Discussion Charlotte A. Gaydos, MS, DrPH Professor Division of Infectious Diseases Johns Hopkins University National Chlamydia Coalition Washington, DC December 3-4, 2009
  • 2.
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  • 5.  
  • 7.
  • 8. Relative Comparison of Sensitivity of Various Types of Tests for Detection of Chlamydia or Gonorrhea *Nucleic Acid Amplification Test NAAT* Signal Amplification Test Direct Probe Test Enzyme Immunoassay Sensitivity Range/Sample 1 10 10 2 10 3 10 4 10 5 10 6 10 7 10 8 Number/ organisms per sample
  • 9.
  • 10. Background Chlamydia load at matched anatomic sites Michel et al. JCM 2007;45:1395-1402
  • 11.
  • 12. 16.0% 5.4% 7.9% 10.4% 4.1% Female U.S. Army Recruits: RESULTS 7.9% Gaydos et al. STD 30:539-544, 2003 Mean Age: 20.6 years. OR 2.8 (proportion <25 yr = 85.8%) 1996: 8.51% 1997: 9.68% 1998: 9.90% 1999: 9.92% p = 0.018, using 1996 as referent
  • 13. South: n = 10,963 (12.3%) Northeast: n = 3,746 (7.5%) Midwest: n = 4,128 (7.3%) West: n = 3,779 (5.8%) Territories: n =391 (9.5.%) Female U.S. Army Recruits: 1996-1999 Chlamydia Prevalence, by urine LCR (n=23,007) CDC Reporting Region: Northeast, South, Midwest, West, Territories 3 individuals missing region assignment.
  • 14. Chlamydia or Gonorrhea (13.6%) ED Mehta SD et al. Sex Transm Dis 2001;28:33 22% >1 sex partner in the past 90 days; 37% male, vol rate 77%; 28% new sex partner in the past 90 days; 76% of infections were undetected by clinicians at initial ED visit
  • 15. Vaginal Swabs Are Appropriate Specimens for Diagnosis of Genital Tract Infection with C. trachomatis Schachter et al. JCM 2003;41:3784-3789 NAAT sensitivity: Vaginal Swabs 93% Cervical Swabs 91% FVU 80.6% Culture Sensitivity 83.5% Specificities All Specimens >99% GenProbe APTIMA COMBO2 now FDA cleared for vaginal swabs
  • 16.
  • 17. Assessment of ease of use of vaginal swabs Most Women reported that vaginal swabs were “easy” to collect!
  • 18.
  • 19.
  • 20.
  • 21.
  • 23.  
  • 24. Female Questionnaire Results: Preference for Sample Type (N=1165) Pelvic 20.7% Urine 7.6% Vaginal or Urine 11.5% Self Vaginal 48.8% Other Combo 11.4%
  • 25. Female Questionnaire Results: Self Collection 90.9% 94.5% N = 1169 N = 1139
  • 26. Female Questionnaire Results Vaginal Collection 96.7% 98.4% 91.7% N = 1114 N = 1113 N =1093
  • 27. Female Questionnaire Results: Preference for Receiving Results (N=1179) 35.5% 9.8% 32.0% 32.7% 32.7%
  • 28.
  • 29.
  • 30.
  • 31. Female CT Prevalence: Results by Age (N = 1191*) 11.1% Infected 6.8% Infected 15.3% Infected *12 did not report age. There were 9 women 14 yr old, all were chlamydia negative 1.2% Infected
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.  
  • 38.  
  • 39. Male Questionnaire Results Home collection (N = 501) Swab 89.8% 94.0% 91.4% Urine 95.3% No swab: 8; No urine 2
  • 40. Male Questionnaire Results Preference for Sample Type 62.7% 62.4% 24.8% More than one answer possible
  • 41. Age category Prevalence of STIs in Males by Age Category 11.1% 39.8% 22.1% 27.0%
  • 42.
  • 43. Acknowledgements Shua Chai, MD, MPH Mathilda Barnes, BS Bulbul Aumakhan, MD, PhD Mary Jett-Goheen, BS Nicole Quinn, BS Patricia Agreda, MS Pamela Whittle, BS Terry Hogan, MPH