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

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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.

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Topics

• Budget Update
• CSPS and Infrastructure Update
• Azithromycin Update
• Laboratory Update
• Surveillance Report Update

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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

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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

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CDC receives..
Regional data submission (quarterly yearend)
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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

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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

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IPP Events

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

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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

STD FP
Region II 2.10- 15.52 2.24-10.26
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CDC Chlamydia / Gonorrhea Laboratory Update

• Laboratory Innovations
• CT variant update
• Chlamydia Immunology Consultation
• Laboratory Guidelines

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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

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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

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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

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Questions?