Region V IPP PM UPdate
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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
Budget Update
CSPS and Infrastructure Update
Azithromycin Update
Laboratory Update
Surveillance Report Update
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
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
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
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%
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
IPP Events
CT Coordinator
» Broad expansion of CT Screening
Partnership for Prevention
2008 Conference
» IPP Epidemiologists
» IPP Open House
» IPP Epi Methods
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
Region II
STD
$2.10- $15.52
FP
$2.24-$10.26
CDC Chlamydia / Gonorrhea
Laboratory Update
Laboratory Innovations
CT variant update
Chlamydia Immunology Consultation
Laboratory Guidelines
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
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
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
Questions?