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

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

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

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  1. Region IIInfertility 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 • CSPS and Infrastructure Update • Azithromycin Update • Laboratory Update • Surveillance Report Update

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

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

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

  6. CSPS 2009 • CSPS 2009 • 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%

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

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

  9. Azithromycin • 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 STD Average $5.29; Median $2.71 • National FP Average $3.91; Median $2.96

  10. CDC Chlamydia / Gonorrhea Laboratory Update • Laboratory Innovations • CT variant update • Chlamydia Immunology Consultation • 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) • 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 • 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 • Will depend on dissemination of the variant from Sweden

  12. Core Concepts for Chlamydia Immunology Consultation • 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 • Screening • Frequency of repeat infections • Consultation planned for either April or May 2008

  13. CDC STD Laboratory Guidelines • 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 • 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?

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