1. Region II Infertility Prevention Project December 12-13 New York City, New York Steven J. Shapiro Infertility Prevention Project Coordinator CDC/CCID/NCHHSTP/DSTDP/PTB Disclaimer: The findings and conclusions in this presentation are those of the author and do not necessarily represent the views of the Centers for Disease Control and Prevention.

2. Topics Budget Update Budget Update CSPS and Infrastructure Update CSPS and Infrastructure Update Azithromycin Update Azithromycin Update Laboratory Update Laboratory Update Surveillance Report Update Surveillance Report Update

3. Budget 2008 Continuing Resolution Continuing Resolution –Funded at Final 2007 levels »Approx. $107 million to grantees Infrastructure Funding Infrastructure Funding »Base Award »Special Project Confidential Adolescent Health Care Project Confidential Adolescent Health Care Project »STD Conference Travel Funds »Data Systems Standardization

4. Data Systems Standardization National IPP Dataset National IPP Dataset »Prevalence Monitoring File Line-listed Data Line-listed Data »Facility Reference File All facilities where screening occurs All facilities where screening occurs Goal: To standardize core data elements both datasets Goal: To standardize core data elements both datasets

5. Regional data submission (quarterly & yearend) Prevalence Monitoring Data Facility Reference File (formerly clinic reference file) Core data elements Enhanced data elements Core data elements Enhanced data elements CDC receives……….. Various file formats Region I SAS Region II SPSS Region III dBase IV Region IV dBaseIV Region V dBase IV Region VI SPSS Region VII MS Excel Region VIII dBase IV Region IX SPSS Region X SPSS Region I SAS Region II SPSS Region III Access Region IV Excel Region V dBase IV Region VI SPSS Region VII EpiInfo Region VIII MS Excel Region IX SPSS Region X SPSS

6. CSPS 2009 CSPS 2009 CSPS 2009 4-5 year Cooperative Agreement 4-5 year Cooperative Agreement –Integration Language Possible increased flexibility in using awarded IPP funds Possible increased flexibility in using awarded IPP funds –GC focused activities 50% to Title X Family Planning 50% to Title X Family Planning –Concurrence Letter Emphasis on completing required IPP activities Emphasis on completing required IPP activities –Ensure CT and GC screening and treatment –Support laboratory testing –Ensure collection of all CDC core data elements –Program Management –Provider Training Program Plans Data Driven Program Plans Data Driven –2%

7. IPP Infrastructure Grant Application vs. Progress Report Application vs. Progress Report OPA Timeline OPA Timeline National Objectives National Objectives Indian Health, Data, PTO, Lab, GC, Other Indian Health, Data, PTO, Lab, GC, Other Roles and Responsibilities Roles and Responsibilities Necessary Activities Necessary Activities Title X Grantee(s) Title X Grantee(s) Expectations Expectations

8. IPP Events CT Coordinator CT Coordinator » Broad expansion of CT Screening Partnership for Prevention Partnership for Prevention 2008 Conference 2008 Conference »IPP Epidemiologists »IPP Open House »IPP Epi Methods

9. Azithromycin Off Patent 2006 Off Patent 2006 »Contract (Pfizer) Sub-ceiling 340B pricing of $95 per 10 doses of 1 gm sachet not longer valid; Available in various formulations and dosages from four manufacturers and numerous distributors nationwide National Range $0.38 - $22.44/dose National Range $0.38 - $22.44/dose »National STD Average $5.29; Median $2.71 »National FP Average $3.91; Median $2.96 STDFP Region II $2.10- $15.52 $2.24-$10.26

10. CDC Chlamydia / Gonorrhea Laboratory Update Laboratory Innovations Laboratory Innovations CT variant update CT variant update Chlamydia Immunology Consultation Chlamydia Immunology Consultation Laboratory Guidelines Laboratory Guidelines

11. Reported plasmid variant of Chlamydia trachomatis A 377 base pair deletion resulting in false negative tests with both the Roche Amplicor and Abbott m2000 tests (not available in the US) A 377 base pair deletion resulting in false negative tests with both the Roche Amplicor and Abbott m2000 tests (not available in the US) Several presentations at ISSDTR (July 2007) indicating that the variant is widespread (maybe up to 30% in some areas) in Sweden (the country where it was first reported) Several presentations at ISSDTR (July 2007) indicating that the variant is widespread (maybe up to 30% in some areas) in Sweden (the country where it was first reported) Extensive testing in other countries have failed to detect the variant in any significant numbers Extensive testing in other countries have failed to detect the variant in any significant numbers There are no reports of the variant in the US based on clinical trial data and assessment of specimens yielding discrepant results among NAATs There are no reports of the variant in the US based on clinical trial data and assessment of specimens yielding discrepant results among NAATs CDC lab is prepared to test specimens if and when the need arises CDC lab is prepared to test specimens if and when the need arises –Will depend on dissemination of the variant from Sweden

12. Core Concepts for Chlamydia Immunology Consultation Natural History of C. trachomatis infection Natural History of C. trachomatis infection –Duration of infection –Development of immune response »Protective »Pathologic »Single vs multiple infections –Effect of treatment Prevention of C. trachomatis related sequelae Prevention of C. trachomatis related sequelae –Screening –Frequency of repeat infections Consultation planned for either April or May 2008 Consultation planned for either April or May 2008

13. CDC STD Laboratory Guidelines ü Phased approach for developing CDC Laboratory Guidelines –First two documents would (A) Chlamydia, Gonorrhea (B) Syphilis –Viral STDs would follow »HSV, HPV, Hepatitis –Other STDs next »Trichomoniasis, Candidiasis, BV, etc ü Process will include two tracks –Chlamydia / gonorrhea track and a syphilis track (consultation meetings being planned for 2008) –Each track will be co-chaired by a CDC laboratory expert and a public health laboratory expert along with a clinical consultant –Track leaders will develop key questions and select subject matter experts to address these questions

14. Questions?