Infertility Prevention Project Region I Boston, Massachusetts November 9, 2011

1. Infertility Prevention ProjectRegion IBoston, MassachusettsNovember 9, 2011 Steven J Shapiro Infertility Prevention Project Coordinator Program and Training Branch National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention Division of STD Prevention

2. TopicsNational Infertility Prevention Project • CSPS 2012 • DSTDP Update • Health Care Reform • Gonorrhea

3. CSPS 2012 • 2012 • @2011 levels • Application Due August 19, 2011 • Revised Budgets Due November 10, 2011 • Streamlined Application • All requirements from FOA 09-902 remain in force • Performance Measures • Additional Guidance • National Conference • Regional IPP Meetings • Supplemental Budgets

4. DSTDP Update • Personnel Changes • Division Realignment • Publications and Current Activities

5. Division of STD Prevention 2012

6. DSTDP Update (2) • Publications • NG with Reduced Susceptibility to Azithromycin- San Diego • DCL- Azithromycin Resistance in Hawaii • 2010 STD Surveillance Report • Current Activities • PCSI • Data Security and Confidentiality Guidelines • Antibiotic-resistant Gonorrhea Outbreak Response Plan

7. DSTDP Update (3) • NCHHSTP Confidentiality and Security Guidelines • Collaborative effort across divisions • In all division FOAs once published, Fall 2011 • 10 Guiding Principles • Collection and Acquisition • Use • Release and Sharing • Storage • Minimum Standards to ensure physical and electronic security, C&S training, and establishment of MOA/MOU. • Required Self-Assessment on all Standards with Compliance Plans

8. CDC Update • National Action Plan for Prevention, Detection, and Management of Infertility (Division of Reproductive Health). • Objectives: • Reduce the burden of infertility and impaired fecundity by promoting behaviors that maintain fertility, by promoting prevention, early detection, and treatment of infections (e.g. chlamydial infection) and other medical conditions that lead to infertility, and by removing or reducing environmental and occupational threats to fertility. • To improve access to the diagnosis and treatment of infertility and eliminate disparities in infertility care. • To improve the efficacy and safety of infertility treatment • To improve the quality of life of people who live with infertility • Outline: Prevention of Infertility, Detection of Infertility, and Management of Infertility. Fertility and Sterility 2010 January;93(1):16.e1-10

9. “Working in a Transformed Health Care System”

10. “Working in a Transformed Health Care System” • Key Issues • Affordable Care Act and Performance Improvement • National HIV/AIDS Strategy • Agency Winnable Battles (HIV, Teen Pregnancy Prevention) • “The Future of IPP” • An Infrastructure-driven Evaluation • Under Regional IPP review and comments • Due to CDC November 15, 2011 • IPP in the Project Areas • Environmental Scan • Recommendations for the Future

11. “The Future of STD Prevention”2012 and Beyond • Assurance • Functioning Surveillance Systems • Local Epidemiology Support • PCSI • Policy Development • Plan Programs using Data- all sorts of data • Assessment and Accountability • Monitoring • Evaluation • Safety Net Coverage

12. DRIP, DRIP, DRIP……

13. Gonorrhea—Rates by Age Among Women Aged 15–44 Years, United States, 2000–2009 Rate (per 100,000 population) Age Group 1,000 30–34 15–19 35–39 20–24 40–44 800 25–29 600 400 200 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year

14. Gonorrhea—Rates by Age Among Men Aged 15–44 Years, United States, 2000–2009 Rate (per 100,000 population) Age Group 750 30–34 15–19 35–39 20–24 40–44 25–29 600 450 300 150 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year

15. Gonorrhea—Rates by Race/Ethnicity, United States, 2000–2009 Rate (per 100,000 population) 800 700 600 500 American Indians/Alaska Natives Asians/Pacific Islanders 400 Blacks 300 Hispanics Whites 200 100 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year

16. Gonorrhea—Rates by County, United States, 2009 Rate per 100,000 population <19.0 (n = 1,405) 19.1–100.0 (n = 1,129) >100.0 (n = 607)

17. Trends in cephalosporin susceptibility:international trends

18. 2000 Possible cefdinir (oral) treatment failure in man with urethritis (MIC=1)

19. 2001 2 cases with decreased cefixime susceptibility (MIC=0.5)

20. 2002 • 30% of isolates with decreased cefixime susceptibility (MIC ≥0.5) • (0% in 1999)

21. 2003 • 4 possible GC cefixime treatment failures in MSW • (Cefixime MICs 0.5–1)

22. 2008 • 2% of isolates with ceftriaxone MICs ≥ 0.6 µg/ml (0.6% in 2006)

23. 2009 • Increases in ceftriaxone MICs • Pharyngeal isolate from CSW • with Ceftriaxone MIC=2 • (subject of recent media “superbug” coverage)

24. 2010 2 cefixime treatment failures (Cefixime MIC 0.25-0.5) ~30% with elevated (≥0.06) ceftriaxone MICs Pharyngeal treatment failure (Ceftriaxone MIC 0.125-0.25) 2 possible cefixime treatment failures (Cefixime MIC 0.25)

25. 2011 Cefixime treatment failure (Cefixime MIC ≥ 0.25)

26. Trends in cephalosporin susceptibility:US trends

27. US sentinel surveillance Monitors trends in NG antibiotic susceptibility 26–29 STD clinic sites Urethral NG isolates obtained from first 25 men per site each month Susceptibility testing by 4–5 regional labs Confirmatory testing by CDC Minimum inhibitory concentrations (MICs) by agar dilution The Gonococcal Isolate Surveillance Project (GISP)

28. GISP sites and regional laboratories —United States, 2000–2010 Seattle Portland Minneapolis Detroit New York City* Philadelphia Chicago Cleveland San Francisco Baltimore Salt Lake City* Cincinnati Las Vegas* Denver Kansas City* Richmond* St. Louis* Los Angeles* Oklahoma City Greensboro* Long Beach* Orange Co. Ft. Bragg* Albuquerque San Diego Birmingham Phoenix Clinic site Dallas Atlanta Lab New Orleans Tripler AMC* Honolulu Miami Anchorage* * Did not participate for entire time period

29. Emergence of FQ Resistance: Hawaii Cipro available FQ not recommended for GC in Hawaii* Reports of FQ resistance Percentage of GISP isolates resistant to ciprofloxacin Hawaii * CDC, MMWR 2000.

30. Emergence of FQ Resistance: California FQ not recommended for GC in California** Hawaii* Percentage of GISP isolates resistant to ciprofloxacin California * CDC, MMWR 2000; ** CDC, MMWR, 2002

31. Emergence of FQ Resistance: MSM FQ not recommended for MSM† Hawaii* California** Percentage of GISP isolates resistant to ciprofloxacin MSM * CDC, MMWR 2000; ** CDC, MMWR, 2002; † CDC, MMWR, 2004.

32. Emergence of FQ Resistance: Rest of the US (Excluding Hawaii & California) FQ not recommended in US‡ Hawaii* MSM† California** Percentage of GISP isolates resistant to ciprofloxacin US * CDC, MMWR 2000; ** CDC, MMWR, 2002; † CDC, MMWR, 2004.; ‡ CDC, MMWR, 2007.

33. Distribution of MICs to Azithromycin, 2006–2010* Percentage of isolates Minimum Inhibitory Concentrations (MICs), µg/ml * Preliminary (Jan-Sept)

34. Distribution of MICs to Azithromycin, 2006–2010* Percentage of isolates Minimum Inhibitory Concentrations (MICs), µg/ml * Preliminary (Jan-Sept)

35. Proportion of isolates with Elevated MICs to Cefixime (≥ 0.25 μg/ml) n=52,785 1.4% (n=77) * Percentage of isolates * p trend < 0.05 Source: Gonococcal Isolate Surveillance Project (GISP)

36. Proportion of isolates with Elevated MICs to Cefixime (≥ 0.25 μg/ml) by Region 3.3% (n=68) n=52,785 * Percentage of isolates * * * p trend < 0.05 Source: Gonococcal Isolate Surveillance Project (GISP)

37. Proportion of isolates with Elevated MICs to Cefixime (≥ 0.25 μg/ml) by Sex of Sex Partner n=50,873 3.9% (n=64) * Percentage of isolates * p trend < 0.05 Note: MSM = Men who have sex with men; MSW = Men who exclusively have sex with women; Source: Gonococcal Isolate Surveillance Project (GISP)

38. Geographic Distribution of Cephalosporin* Alerts , 2005 *Cefixime or Ceftriaxone

39. Geographic Distribution of Cephalosporin* Alerts, 2006 *Cefixime or Ceftriaxone

40. Geographic Distribution of Cephalosporin* Alerts, 2009 *Cefixime or Ceftriaxone

41. Geographic Distribution of Cephalosporin* Alerts, 2010 Orange Co. San Diego *Cefixime or Ceftriaxone

42. Programmatic response

43. Programmatic responsechallenges

44. Challenges • Lack of alternative treatment options • Low awareness of problem • Lack of clear laboratory criteria for resistance • GISP timeliness and sensitivity • Lack of screening at non-genital anatomic sites • Declining culture and AST capacity • Declining STD control resources • Low likelihood of preventing/controlling resistance

45. Number of New Systemic Antibacterial Agents Approved by the FDA, 1983–2007 Number of New Antimicrobial Agents Approved Spellberg B, Guidos R, Gilbert D et al. Clin Infect Dis 2008

46. Challenges • Lack of alternative treatment options • Low awareness of problem • Lack of clear laboratory criteria for resistance • GISP timeliness and sensitivity • Declining culture and AST capacity • Declining STD control resources • Low likelihood of preventing/controlling resistance

47. Recent Media Coverage of Gonorrhea Resistance

48. http://www.theonion.com/articles/new-antibioticresistant-gonorrhea-strain-found,20926/http://www.theonion.com/articles/new-antibioticresistant-gonorrhea-strain-found,20926/

49. Challenges • Lack of alternative treatment options • Low awareness of problem • Lack of clear laboratory criteria for resistance • GISP timeliness and sensitivity • Declining culture and AST capacity • Declining STD control resources • Low likelihood of preventing/controlling resistance

50. Programmatic responseproposed response plans