Using Self-Collected Specimens to Improve and Extend Delivery of Chlamydia Screening: A Roundtable Discussion Charlotte A....
Description and Purpose <ul><li>Is the use of self-collected specimens to improve chlamydia screening an effective strateg...
Background <ul><li>Types of self-collected specimens for chlamydia screening: </li></ul><ul><ul><li>Urine Started about 19...
 
 
Male Diagram Female Diagram
Noninvasive Screening for STDS Advantages  <ul><li>Acceptability to the patient, accurate </li></ul><ul><li>Avoids bias in...
Relative Comparison of Sensitivity of  Various Types of Tests for Detection of  Chlamydia or Gonorrhea   *Nucleic Acid Amp...
New Specimen Types for Amplification Technologies for STD Diagnosis <ul><li>Urine </li></ul><ul><ul><li>PCR: chlamydia, go...
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. <ul><li>23,010 non-health care seeking female...
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 ...
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 ...
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% ...
Vaginal Swabs Are Appropriate  Specimens for  Diagnosis of Genital Tract Infection with  C. trachomatis Schachter et al. J...
Patients’ First  Preference for  Sample Type  <ul><li>More women (46.7%) preferred collection of vaginal swabs </li></ul><...
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) <ul><li>Military women *  (n=1403; prev 11.8%) reported ...
<ul><li>Conclusions and Recommendations from the NIH Workshop  </li></ul><ul><li>on the Importance of Self-Obtained Vagina...
Populations and Venues  Where   Self Sampling Has Been Used <ul><li>Groups </li></ul><ul><ul><li>Military </li></ul></ul><...
Non-invasive Sampling Methods in Epidemiology Studies Summary:  <ul><li>Age is a risk factor! </li></ul><ul><li>Traditiona...
www.iwantthekit.org
 
Female Questionnaire Results: Preference for Sample Type  (N=1165) Pelvic 20.7% Urine 7.6% Vaginal or Urine 11.5% Self Vag...
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...
RESULTS- Use of the Female Kit  (N=1199) <ul><li>Confirmed Treated </li></ul><ul><ul><ul><ul><li>CT:  96.5% </li></ul></ul...
Are users from high risk groups? <ul><li>37% reported prior CT </li></ul><ul><li>55.4% reported prior STD; 3.1% PID </li><...
Female CT Prevalence: Results by Age  (N = 1191*) 11.1% Infected 6.8% Infected 15.3% Infected *12 did not report age. Ther...
Results: Socio-Economic  <ul><li>Education (N=566):  </li></ul><ul><ul><li>< High school  5.8% </li></ul></ul><ul><ul><li>...
CONCLUSIONS: Female Kit Use <ul><li>Female Internet use supported the concept of an educational STD website that could enc...
Remaining Policy & Public Health Issues <ul><li>Who should pay? Best use of resources? </li></ul><ul><li>Need for increase...
Points for Discussion <ul><li>What is the acceptability of self-collected specimens for detection of STIs? </li></ul><ul><...
Points for Discussion <ul><li>How can adolescents and adults seek follow-up care if infected? </li></ul><ul><li>What would...
 
 
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   <ul><li>Consistent Condom use:    13.2% </li></ul><ul><li>CT infected:        6.8%...
Acknowledgements Shua Chai, MD, MPH Mathilda Barnes, BS Bulbul Aumakhan, MD, PhD Mary Jett-Goheen, BS Nicole Quinn, BS Pat...
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Charlotte Gaydos: Using Self-Collected Specimens to Improve and Extend Delivery of Chlamydia Screening

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Using SElf-Collected Speciments to Improve and Extend Delivery of Chlamydia Screening, a roundtable discussion led by Charlotte Gaydos

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

  1. 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. 2. Description and Purpose <ul><li>Is the use of self-collected specimens to improve chlamydia screening an effective strategy to deliver a preventive service in a cost-effective manner in a reformed health care system? </li></ul><ul><li>Our purpose is to provide an opportunity for our roundtable members who have different backgrounds to share ideas in an informal setting. We plan for our discussion to be interactive and engaging </li></ul>
  3. 3. Background <ul><li>Types of self-collected specimens for chlamydia screening: </li></ul><ul><ul><li>Urine Started about 1995, not as sensitive as cervical </li></ul></ul><ul><ul><li>Vaginal Started about 1998, more sensitive than urines and as sensitive as cx </li></ul></ul><ul><ul><li>Penile New and not yet proven to be useful </li></ul></ul><ul><ul><li>Rectal New and not yet proven to be useful </li></ul></ul>
  4. 6. Male Diagram Female Diagram
  5. 7. Noninvasive Screening for STDS Advantages <ul><li>Acceptability to the patient, accurate </li></ul><ul><li>Avoids bias in screening only clinic-based populations; alternative venues possible </li></ul><ul><li>Identifies asymptomatic infections resulting in early treatment and prevention </li></ul><ul><li>Cost-effective and cost savings (pooling) </li></ul><ul><li>Improves outreach to underserved populations </li></ul><ul><li>Utilizes highly sensitive and specific NAAT </li></ul>
  6. 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
  7. 9. New Specimen Types for Amplification Technologies for STD Diagnosis <ul><li>Urine </li></ul><ul><ul><li>PCR: chlamydia, gonorrhea </li></ul></ul><ul><ul><li>SDA: chlamydia, gonorrhea </li></ul></ul><ul><ul><li>TMA: chlamydia, gonorrhea </li></ul></ul><ul><li>Vaginal Swabs </li></ul><ul><ul><li>PCR: chlamydia, gonorrhea </li></ul></ul><ul><ul><li>SDA: chlamydia, gonorrhea </li></ul></ul><ul><ul><li>TMA: chlamydia, gonorrhea </li></ul></ul><ul><ul><ul><li>Self-administered vaginal swabs (SAS) </li></ul></ul></ul><ul><ul><ul><li>HCW-administered vaginal swabs </li></ul></ul></ul>
  8. 10. Background Chlamydia load at matched anatomic sites Michel et al. JCM 2007;45:1395-1402
  9. 11. Four-Year Study of Urine-Based Screening of Female Army Recruits in the U.S. <ul><li>23,010 non-health care seeking female Army recruits enrolled at Fort Jackson, SC </li></ul><ul><li>Urine-based screening by LCR </li></ul><ul><li>Acceptance rate was 80% </li></ul>Gaydos et al. STD 30:539-544, 2003
  10. 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
  11. 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.
  12. 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
  13. 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
  14. 16. Patients’ First Preference for Sample Type <ul><li>More women (46.7%) preferred collection of vaginal swabs </li></ul><ul><li>Self-obtained samples (vaginal and urine) were preferred by 71.5% of women </li></ul>
  15. 17. Assessment of ease of use of vaginal swabs Most Women reported that vaginal swabs were “easy” to collect!
  16. 18. Preference and Accuracy of Self-administered Vaginal Swabs (SAS) <ul><li>Military women * (n=1403; prev 11.8%) reported use of SAS </li></ul><ul><li>generally acceptable </li></ul><ul><ul><li>90% FVU vs. 69.6% SAS reported “felt comfortable” </li></ul></ul><ul><ul><li>60.4% reported urine “easier” </li></ul></ul><ul><ul><li>Relative sensitivity FVU 89.7%; SAS 87.6% (p= ns) </li></ul></ul><ul><li>Female prisoners ** (n=535; prev 2.3%) 57% reported no </li></ul><ul><li>difference between urine and SAS </li></ul><ul><ul><li>30% prefer SAS in the future vs urine (21%) </li></ul></ul><ul><ul><li>half expressed no preference </li></ul></ul><ul><ul><li>60% preferred SAS vs. pelvic exam (23%); 17% no pref . </li></ul></ul>*Hsieh et al. STD 2003;30:769-773; ** Newman et al. STD 2003;30:306-309
  17. 19. <ul><li>Conclusions and Recommendations from the NIH Workshop </li></ul><ul><li>on the Importance of Self-Obtained Vaginal Specimens for Detection of Sexually Transmitted Infections (Hobbs et al. STD 2008;35:8-13) </li></ul><ul><li>Self-obtained vaginal swabs (SOVs) are well-accepted by women and these specimens perform better than urine for the diagnosis of CT and GC infections using nucleic acid amplification tests. </li></ul><ul><li>More widespread use of SOVs for the detection of CT and GC offers potential benefit for public health. Women who feel they are at risk for CT or GC infection should have the opportunity for testing using self-motivated, self-collection in their homes. </li></ul><ul><li>SOVs and other self-collected specimens are promising clinical and research tools for detection of sexually transmitted viruses as well as for Trichomonas vaginalis, Mycoplasma genitalium and bacterial vaginosis. </li></ul><ul><li>The public health and STI research communities must work with the diagnostics industry to obtain FDA clearance for the routine use of SOVs in the diagnosis of CT and GC infections. </li></ul><ul><li>Independent validation of SOVs by diagnostic laboratories is needed to facilitate innovative approaches including self-sampling in a wide variety of circumstances. </li></ul>
  18. 20. Populations and Venues Where Self Sampling Has Been Used <ul><li>Groups </li></ul><ul><ul><li>Military </li></ul></ul><ul><ul><li>Schools </li></ul></ul><ul><ul><li>Detention/Jails </li></ul></ul><ul><ul><li>Job Corps </li></ul></ul><ul><li>Outreach </li></ul><ul><ul><li>Street/Home </li></ul></ul><ul><ul><li>Drug Rx clinics </li></ul></ul><ul><ul><li>Homeless shelters </li></ul></ul><ul><ul><li>Recreation centers </li></ul></ul><ul><ul><li>Shopping centers </li></ul></ul><ul><li>Other Clinics </li></ul><ul><ul><li>Emergency departments </li></ul></ul><ul><ul><li>Family planning </li></ul></ul><ul><ul><li>Teen clinics </li></ul></ul><ul><ul><li>HMOs </li></ul></ul><ul><ul><li>Other Countries </li></ul></ul><ul><ul><li>Czech/Slovak Republic </li></ul></ul><ul><ul><li>Uganda, Zimbabwe </li></ul></ul><ul><ul><li>Peru </li></ul></ul><ul><ul><li>China, India </li></ul></ul>
  19. 21. Non-invasive Sampling Methods in Epidemiology Studies Summary: <ul><li>Age is a risk factor! </li></ul><ul><li>Traditional risk factors </li></ul><ul><li>Geography is important </li></ul><ul><li>Non-traditional venues possible </li></ul><ul><li>Non-traditional patients possible </li></ul><ul><li>“ The more you look the more </li></ul><ul><li>you find” </li></ul><ul><li>Repeat infections are common </li></ul><ul><li>Self sampling methods are accurate and acceptable </li></ul><ul><li>Home collected samples with </li></ul><ul><li>mailing might make a difference </li></ul><ul><li>in reaching those most at risk </li></ul>
  20. 22. www.iwantthekit.org
  21. 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%
  22. 25. Female Questionnaire Results: Self Collection 90.9% 94.5% N = 1169 N = 1139
  23. 26. Female Questionnaire Results Vaginal Collection 96.7% 98.4% 91.7% N = 1114 N = 1113 N =1093
  24. 27. Female Questionnaire Results: Preference for Receiving Results (N=1179) 35.5% 9.8% 32.0% 32.7% 32.7%
  25. 28. RESULTS- Use of the Female Kit Requested by Internet email: 97.1%, Phone: 2.9% 31.8 % retuned requested kits total (40.1% 2008) <ul><li>Of 2029 tested through October, 2009 </li></ul><ul><ul><ul><li>9.7% CT positive </li></ul></ul></ul><ul><ul><ul><li>1.2% GC positive </li></ul></ul></ul><ul><li>Of 1359 tested for Trichomonas since Sept 2006: </li></ul><ul><li>10.4% positive </li></ul>
  26. 29. RESULTS- Use of the Female Kit (N=1199) <ul><li>Confirmed Treated </li></ul><ul><ul><ul><ul><li>CT: 96.5% </li></ul></ul></ul></ul><ul><ul><ul><ul><li>GC: 100% </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Tric 100% </li></ul></ul></ul></ul><ul><li>Median age of female submitters was 23 yr </li></ul><ul><ul><ul><li>Positives: median age 20 yr (range 15-45 yr) </li></ul></ul></ul><ul><ul><ul><li>Negatives: median age 23 yr (range 14-63) </li></ul></ul></ul><ul><ul><ul><li>(p < 0.0001) </li></ul></ul></ul><ul><li>Median age first sex : positives: 15.2 yr negatives: 15.6 yr (p=0.009) </li></ul>
  27. 30. Are users from high risk groups? <ul><li>37% reported prior CT </li></ul><ul><li>55.4% reported prior STD; 3.1% PID </li></ul><ul><li>55.2% drink before sex </li></ul><ul><li>22.5% reported forced sex </li></ul><ul><li>79.2% reported oral sex; 31.1% rectal sex </li></ul><ul><li>38.6% reported new sex PN; 59.2% multi PN </li></ul><ul><li>13.7% use condoms always </li></ul><ul><li>45.2% reported 2-4 PN previous yr; 11.3% 5-9 </li></ul><ul><li>Multivariate analysis: Age <25 yr had OR 3.4 </li></ul>
  28. 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
  29. 32. Results: Socio-Economic <ul><li>Education (N=566): </li></ul><ul><ul><li>< High school 5.8% </li></ul></ul><ul><ul><li>High School 41.9% </li></ul></ul><ul><ul><li>Community College 24.6% </li></ul></ul><ul><li>Insurance (N=560): 61.6% </li></ul><ul><ul><li>Medicaid eligible : yes 10.4%, </li></ul></ul><ul><ul><ul><ul><ul><li>no 50.4% </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>not sure 39.2% </li></ul></ul></ul></ul></ul><ul><ul><li>College 14.0% </li></ul></ul><ul><ul><li>Masters 3.7% </li></ul></ul><ul><ul><li>Other 8.0% </li></ul></ul><ul><ul><li>HMO 39.2% </li></ul></ul><ul><ul><li>PPO 33.0% </li></ul></ul><ul><ul><li>Other 26.3% </li></ul></ul><ul><ul><li>Not sure 1.5% </li></ul></ul><ul><li>Income, annual: </li></ul><ul><ul><li>< 21 yr (n=158) <$10,000 27.9% </li></ul></ul><ul><ul><li> $10,000- 50,000 49.4% </li></ul></ul><ul><ul><ul><ul><ul><li>$50,000-100,000 18.4% </li></ul></ul></ul></ul></ul><ul><ul><li>> 21 yr (n=387) <$10,000 27.9% </li></ul></ul><ul><ul><ul><ul><ul><li>$10,000- 50,000 62.3% </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>$50,000-100,000 8.5% </li></ul></ul></ul></ul></ul>
  30. 33. CONCLUSIONS: Female Kit Use <ul><li>Female Internet use supported the concept of an educational STD website that could encourage home sampling </li></ul><ul><li>Most collection kits were email requested </li></ul><ul><li>High prevalence of chlamydia and trichomonas </li></ul><ul><li>High level of sexual risk; treatment possible </li></ul><ul><li>Women rated Internet screening easy to very easy; would use again, but 31.8% returned kits </li></ul><ul><li>The Internet recruitment method may help screen women who otherwise would not get tested for chlamydia and other STDs </li></ul>
  31. 34. Remaining Policy & Public Health Issues <ul><li>Who should pay? Best use of resources? </li></ul><ul><li>Need for increased resources for improved screening in non-clinic based setting </li></ul><ul><li>Partner notification and treatment of both infected partners and their sexual partners. </li></ul><ul><li>Internet notification? ( www.inSpot.com ) </li></ul><ul><li>CDC e-cards </li></ul>
  32. 35. Points for Discussion <ul><li>What is the acceptability of self-collected specimens for detection of STIs? </li></ul><ul><li>How do we evaluate the reliability and accuracy of genital swabs and urines for detection of chlamydia </li></ul><ul><ul><li>What are the most common barriers to </li></ul></ul><ul><ul><li>self-collected specimen screening? </li></ul></ul><ul><ul><li>Cost barriers, associated stigmas, others? </li></ul></ul>
  33. 36. Points for Discussion <ul><li>How can adolescents and adults seek follow-up care if infected? </li></ul><ul><li>What would an effective project using self-collected specimens look like? </li></ul><ul><li>What might be the over all costs and benefits? </li></ul><ul><li>What are our opportunities to expand the use of self-collected specimens for chlamydia testing? </li></ul>
  34. 39. Male Questionnaire Results Home collection (N = 501) Swab 89.8% 94.0% 91.4% Urine 95.3% No swab: 8; No urine 2
  35. 40. Male Questionnaire Results Preference for Sample Type 62.7% 62.4% 24.8% More than one answer possible
  36. 41. Age category Prevalence of STIs in Males by Age Category 11.1% 39.8% 22.1% 27.0%
  37. 42. Results – Behavioral – Males N = 501 <ul><li>Consistent Condom use: 13.2% </li></ul><ul><li>CT infected: 6.8% </li></ul><ul><li>CT uninfected: 14.1% (p = 0.119) </li></ul><ul><li>Hx of STDs overall: 33.3% </li></ul><ul><li>Hx of Chlamydia overall 20.8% </li></ul><ul><li>Multiple PN last yr: 73.5% </li></ul><ul><li>New partner: 51.4% </li></ul><ul><li>Anal sex: 55.7% </li></ul><ul><li>Oral sex: 96.4% </li></ul><ul><li>Female PN: 88.8%; Male only: 7.7%; Both: 3.7% </li></ul><ul><li>Drinking during sex 72.0% </li></ul>
  38. 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

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