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Region II Infertility Prevention Project December 12 -13 New York City, New York Steven 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.

Topics n n n Budget Update CSPS and Infrastructure Update Azithromycin Update Laboratory Update Topics n n n Budget Update CSPS and Infrastructure Update Azithromycin Update Laboratory Update Surveillance Report Update

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

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

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

CSPS 2009 n n n 4 -5 year Cooperative Agreement – Integration Language Possible CSPS 2009 n n n 4 -5 year Cooperative Agreement – Integration Language Possible increased flexibility in using awarded IPP funds – GC focused activities 50% to Title X Family Planning – Concurrence Letter 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 – 2%

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

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

Azithromycin n Off Patent 2006 » Contract (Pfizer) Sub-ceiling 340 B pricing of $95 Azithromycin n Off Patent 2006 » Contract (Pfizer) Sub-ceiling 340 B 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 n National Range $0. 38 - $22. 44/dose » National STD Average $5. 29; Median $2. 71 » National FP Average $3. 91; Median $2. 96 Region II STD $2. 10 - $15. 52 FP $2. 24 -$10. 26

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

Reported plasmid variant of Chlamydia trachomatis n A 377 base pair deletion resulting in Reported plasmid variant of Chlamydia trachomatis n A 377 base pair deletion resulting in false negative tests with both the Roche Amplicor and Abbott m 2000 tests (not available in the US) n 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) n Extensive testing in other countries have failed to detect the variant in any significant numbers n There are no reports of the variant in the US based on clinical trial data and assessment of specimens yielding discrepant results among NAATs n CDC lab is prepared to test specimens if and when the need arises – Will depend on dissemination of the variant from Sweden

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

CDC STD Laboratory Guidelines ü Phased approach for developing CDC Laboratory Guidelines – First 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

Questions? Questions?