Steven J Shapiro Adolescent and Youth Strategic Priority Coordinator Program Development and Quality Improvement Branch Infertility Prevention Project Region I Wells Beach, Maine June 4-5, 2012 National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention Division of STD Prevention

Topics National Infertility Prevention Project  CSPS  DSTDP Update  Health Care Reform  Gonorrhea

CSPS 2013  Streamlined Application  90 Day Application Period- Due August 20, 2012  Minimal Write-up Narrative and Required Tables (2-4) cannot exceed 30 pages Appendices limited to 20 pages  Funding Levels  Special Needs Budget (25% of total base award) DSTDP Priority; STD Prevention Investment sustainable without future funding; Have measureable outcomes and demonstrate effectiveness

CSPS 2013 (cont)  Performance Measures  IPP Letter of Concurrence  Additional Guidance  In-person attendance of three (3) representatives (project director, program manager, epidemiologist) at regional [quadrant] or national; STD prevention meetings.  IPP must be developed in partnership with family planning and laboratory partners. Plans should be shared with the regional IPP coordinator with sufficient time to address suggestions and concerns. CSPS possible 0.189% rescission- reflected in final 30% of 2012 Funding Amount. carry-forward requests for unspent 2011 funds should be submitted as soon as possible

CSPS 2014  Significant Changes  Streamline and Page Limit  Use 2012 Annual Data  Use Funding to support state and local plans  FOA Published March 1, 2013  Applications due May 13, 2013  Opportunities for input  Regional IPP meetings- NCSD  Townhall Meeting- Minneapolis  Consultation with National Partners Mid-July 2012  by August 31,

DSTDP Update  Division Realignment

Division of STD Prevention 2012

Photo Title – Myriad Pro, Bold, Shadow, 20pt Caption for photo, references, citations, or credits – Myriad Pro, 14pt Program Coordinator Regions

Project Area Assignments Region ( Jurisdictions )STD Program Coordinator STD Business Official Western (16) Steven Shapiro – Interim Shean Johnson HHS Regions VIII, IX, X Midwest (13) Vickie Boazman-Holmes Shean Johnson HHS Regions V, VII + KY & WV South (12) Sheldon Black David Byrum HHS Regions IV, VI Northeast (18) Dayne Collins – Interim David Byrum HHS Regions I, II, III Laurie Anderson – Interim 4/1/12

Geographic Distribution Legend Norm Fikes Dan George Melinda Salmon John Paffel Jim Lee

“Working in a Transformed Health Care System” States’ Progress Effect on STD Prevention

Health Reform Progress  Categories  Health Reform Coordination  Insurance Exchanges  Commercial Insurance  Eligibility and Enrollment  Provider Capacity  Benefit Design  Care Coordination  Data  Population Health  Public Engagement  Quality and Efficiency Massachusetts 52% Connecticut 20% Rhode Island 17% Vermont 12% Maine 10% New Hampshire 4% National 7% National Academy for State Health Reform Robert Wood Johnson Foundation Data accessed June 2, 2012

“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

“The Future of STD Prevention” 2012 and Beyond  Strategic Priorities  National Prevention Strategy  National HIV/AIDS Strategy  IOM Women’s Preventative Services  Winnable Battles  Infrastructure and Capacity Building Surveillance, High Quality Data, Impactful Interventions, Structural Enhancements, and Measurable Progress  Prevention through Healthcare  Sexual Health

STD Prevention Activities and Priorities  Activities  Screening/Testing  Linkage to Care (Treatment Assurance)  Partner Services  Health Promotion  Priorities  Adolescents and Youth  MSM  MDR GC  Congenital Syphilis

“ The Infertility Prevention Project in a Transformed Health Care System”  “The Future of IPP”  An Infrastructure-driven Evaluation o IPP in the Project Areas o Environmental Scan o Recommendations for the Future  Decision Analysis Process  New OPA-CDC joint Training Center FOA Published April 12, 2012 Applications due June 11, 2012 Targeting August 1, 2012 for start date  IPP in 2014: ???

DRIP, DRIP, DRIP……

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

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

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

PROGRAMMATIC RESPONSE CHALLENGES

Major Challenges  Lack of alternative treatment options  Low awareness of problem

Other Challenges  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

PROGRAMMATIC RESPONSE WHAT ARE WE DOING?

Current CDC Activities  Development of Response Plan  Dual Therapy Clinical Trial  Surveillance  Increasing awareness  Publication and media outreach  Inclusion of NG in AMR discussion  Top 6 Health Menaces of 2011 (Men’s Health, Dec 2011)  CDC Public Health Grand Rounds (May 2012)  Testing of culture media for field conditions  Evaluating molecular mutations causing resistance

Conclusions  Cephalosporin-resistant gonorrhea likely to occur in US  Significant challenges exist  Start planning now to drive down GC morbidity  Start developing infrastructure to  Detect resistant strains  Slow their spread  Limit bad outcomes

ITS NOT JUST GONORRHEA……

Chlamydia—Rates by County, United States, 2010 <300.0(n = 1,962) Rate per 100,000 population 300.1–400.0(n = 418) >400.0(n = 762)

Acknowledgements CDC  Gail Bolan  John Papp  Kim Workowski  Tom Peterman  Kevin O’Connor  Dayne Collins  Sarah Kidd  Robert Kirkcaldy  Hillard Weinstock  Mark Stenger  Lizzi Torrone

Questions? Thank you For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone: CDC-INFO ( )/TTY: Web: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of STD Prevention

TRENDS IN CEPHALOSPORIN SUSCEPTIBILITY: INTERNATIONAL TRENDS

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

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

Decreased cephalosporin susceptibility: possible cefixime treatment failures At least 49 possible treatment failures with oral cephalosporins Increasing MICs to cephalosporins reported Treatment failures reported

TRENDS IN CEPHALOSPORIN SUSCEPTIBILITY: US TRENDS

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

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

PROGRAMMATIC RESPONSE

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

Recent Media Coverage of Gonorrhea Resistance

US Cephalosporin-Resistant Gonorrhea Response Plan  Surveillance  Working Case Definition of Ceph-R NG  Treatment of initial cases  Public health investigation and case follow-up

Important Questions  Treatment  Dual Therapy Clinical Trial  But need additional trials, especially of oral agents, with efficacy for pharyngeal GC, well tolerated  Case detection  Asking clinicians to report treatment failures – is this feasible/realistic?  Test-of-Cure  Under what conditions to recommend and how to operationalize?  When do Aptima GC tests turn negative after treatment?  Does this differ by anatomic site? (different organism load, different drug efficacy, …)

Important Questions  Does susceptibility differ by anatomic site?  Does the pharynx play a role in resistance?  Does domestic selection pressure contribute to resistance?  Why are MSM more likely to be infected with resistant strains?  Is surveillance of urethral isolates adequate?  Treatment recommendation implications  GC Culture  What transport media or culture kit best maintains viability in the field?

Activities to Consider  Local and state health departments Consider enhanced surveillance Develop knowledge of where to obtain culture & AST Maintain vigilance for treatment failures Target and enhance GC control/prevention efforts  Clinicians Screen for GC Treat gonorrhea with recommend regimen Maintain vigilance for treatment failures Report treatment failure  Laboratorians Maintain culture capacity Report isolates with decreased susceptibility  Patients & at-risk populations Safer sex Seek care for symptoms, return if symptoms don’t resolve

Chlamydia – “In the Works”  Updating Estimates Manuscript 2.8 million cases in 2000…..????? In 2008  Identifying Predictors of Infection in Women 26+ w/NHANES  Collaborative Data Analysis with England’s HPA National Chlamydia Screening Programme  National STD Prevention Conference-Minneapolis March 2012 At least 15 IPP-related posters/presentations accepted Pre-conference IPP Epi-Methods meeting ( PM 3/12/12)

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

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