Transcript Region V IPP PM UPdate

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
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Budget Update
CSPS and Infrastructure Update
Azithromycin Update
Laboratory Update
Surveillance Report Update
Budget 2008
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Continuing Resolution
– Funded at Final 2007 levels
» Approx. $107 million to grantees
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Infrastructure Funding
» Base Award
» Special Project
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Confidential Adolescent Health Care Project
» STD Conference Travel Funds
» Data Systems Standardization
Data Systems Standardization
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National IPP Dataset
» Prevalence Monitoring File
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Line-listed Data
» Facility Reference File
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All facilities where screening occurs
Goal: To standardize core data
elements both datasets
CDC receives………..
Regional data submission
(quarterly & yearend)
Prevalence Monitoring Data
Various file formats
Region I
SAS
Core data elements
Enhanced data elements
Region II
SPSS
Region III Region IV Region V
dBase IV dBaseIV dBase IV
Region VI Region VII Region VIII Region IX Region X
SPSS
EpiInfo
dBase IV
SPSS
SPSS
Facility Reference File
(formerly clinic reference file)
Core data elements
Enhanced data elements
Region I
SAS
Region II Region III Region IV Region V
SPSS
Access
Excel
dBase IV
Region VI Region VII Region VIII Region IX Region X
SPSS
MS Excel MS Excel
SPSS
SPSS
CSPS 2009
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CSPS 2009
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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
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Application vs. Progress Report
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OPA Timeline
National Objectives
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Indian Health, Data, PTO, Lab, GC, Other
Roles and Responsibilities
 Necessary Activities
 Title X Grantee(s)
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Expectations
IPP Events
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CT Coordinator
» Broad expansion of CT Screening
Partnership for Prevention
 2008 Conference
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» IPP Epidemiologists
» IPP Open House
» IPP Epi Methods
Azithromycin
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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
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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
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Laboratory Innovations
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CT variant update
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Chlamydia Immunology Consultation
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Laboratory Guidelines
Reported plasmid variant of
Chlamydia trachomatis
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A 377 base pair deletion resulting in false negative tests with
both the Roche Amplicor and Abbott m2000 tests (not available
in the US)
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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)
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Extensive testing in other countries have failed to detect the
variant in any significant numbers
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There are no reports of the variant in the US based on clinical
trial data and assessment of specimens yielding discrepant
results among NAATs
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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
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Natural History of C. trachomatis infection
– Duration of infection
– Development of immune response
» Protective
» Pathologic
» Single vs multiple infections
– Effect of treatment
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Prevention of C. trachomatis related sequelae
– Screening
– Frequency of repeat infections
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Consultation planned for either April or May 2008
CDC STD Laboratory Guidelines
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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
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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?