1. IPP Infrastructure Measures of Effectiveness: Preliminary Data and Next Steps Kelly Morrison Opdyke, MPH Region II Infertility Prevention Project Cicatelli Associates Inc. 2008 National STD Prevention Conference March 12, 2008 – Chicago, Illinois, USA

2. National Infertility Prevention Project (IPP) and Region II Goal is reduction of STD-related infertility through targeted screening & treatment of women for Chlamydia trachomatis Goal is reduction of STD-related infertility through targeted screening & treatment of women for Chlamydia trachomatis Funded through a Memorandum of Agreement (MOA) between two federal health agencies in US Funded through a Memorandum of Agreement (MOA) between two federal health agencies in US Centers for Disease Control & Prevention (CDC) Centers for Disease Control & Prevention (CDC) Office of Population Affairs (OPA) Office of Population Affairs (OPA) Majority of chlamydia screening occurs in publicly funded Family Planning (FP) and STD clinics Majority of chlamydia screening occurs in publicly funded Family Planning (FP) and STD clinics

3. National Infertility Prevention Project (IPP) and Region II Administered through 10 HHS Regions & IHS Administered through 10 HHS Regions & IHS Region II consists of five Project Areas: Region II consists of five Project Areas: New Jersey, New York City, New York State, Puerto Rico and the US Virgin Islands New Jersey, New York City, New York State, Puerto Rico and the US Virgin Islands

4. Chlamydia – United States Most commonly reported bacterial STD: >1 million cases reported to CDC in 2006 (of an estimated 2.8 million cases). Most commonly reported bacterial STD: >1 million cases reported to CDC in 2006 (of an estimated 2.8 million cases). Majority (>75%) of Chlamydia trachomatis (CT) infections occur among women age 15-24 years. In 2006, median state-specific chlamydia test positivity in 15-24 year old women in FP clinics was 6.7% (range 2.8% to 16.9%). Majority (>75%) of Chlamydia trachomatis (CT) infections occur among women age 15-24 years. In 2006, median state-specific chlamydia test positivity in 15-24 year old women in FP clinics was 6.7% (range 2.8% to 16.9%). In the US, chlamydia positivity among 15-24 year old women in FP clinics has remained largely flat since 2001. In the US, chlamydia positivity among 15-24 year old women in FP clinics has remained largely flat since 2001. Source: 2006 CDC Surveillance Report & Chlamydia Supplement

6. Adjusted for lab test type & sensitivity based on CDC methodology

8. CDC Chlamydia Screening Guidelines CDC recommends screening all sexually active women age ≤25 annually, and screening of older women with risk factors (e.g., those who have a new sex partner or multiple sex partners) CDC recommends screening all sexually active women age ≤25 annually, and screening of older women with risk factors (e.g., those who have a new sex partner or multiple sex partners) Source: 2006 STD Treatment Guidelines

9. Key Program Questions Are providers appropriately targeting use of CT tests according to national screening guidelines? Are providers appropriately targeting use of CT tests according to national screening guidelines? What is the screening coverage among the target population of females ≤25 yrs? What is the screening coverage among the target population of females ≤25 yrs? How can screening coverage among the most at risk be maximized? How can screening coverage among the most at risk be maximized? Given the overall low positivity among females >25 yrs, how can we better identify those at risk for infection? Given the overall low positivity among females >25 yrs, how can we better identify those at risk for infection?

10. National IPP Measures of Effectiveness (established by CDC in 2007) Measure: CT Test Utilization Proportion of chlamydia tests conducted on females, stratified by age group Data Source: IPP Prevalence Monitoring Data Data Source: IPP Prevalence Monitoring Data Measure: CT Screening Coverage in FP Proportion of female Family Planning users screened for chlamydia, by age group Data Source: Family Planning Annual Report Tables 1 & 11 Data Source: Family Planning Annual Report Tables 1 & 11

11. Characteristics of Selected Data Sources for IPP Measures of Effectiveness Characteristic (Region II data sets) IPPFPAR Readily available, nationally standardized data set YesYes Stratified by age and gender YesYes Provides unduplicated count of unique clients seen and clients tested NoYes Includes data from non-IPP sites NoYes Provides information on visit type NoNo Provides information about risk factors or signs/symptoms related to CT testing Maybe*No *Clinical signs and Sx and risk Hx are not standardized or consistently reported.

12. Measure: CT Test Utilization Data Source: Region II IPP Prevalence Monitoring Data Region II CY 2005 CY 2006 Age (Years) # Female Tests % Tested by Age # Female Tests % Tested by Age 15-19 58,660 58,66023.7% 64,071 64,07124.9% 20-24 88,131 88,13135.7% 91,209 91,20935.4% 25-29 45,986 45,98618.6% 47,087 47,08718.3% >29 54,362 54,36222.0% 55,096 55,09621.4% TOTAL 247,139 247,139100.0% 257,463 257,463100.0%

14. Measure: CT Test Utilization Interpretation of data Interpretation of data ~40% of chlamydia tests among females reported to the Region II IPP in CY2005 and CY2006 were for females ≥25 years of age. These tests accounted for just ~20% of positive tests. ~40% of chlamydia tests among females reported to the Region II IPP in CY2005 and CY2006 were for females ≥25 years of age. These tests accounted for just ~20% of positive tests. Low positivity (~2%) suggests more aggressive targeting of high-risk clients >29 years is needed. Low positivity (~2%) suggests more aggressive targeting of high-risk clients >29 years is needed. Data limitations Data limitations Cannot reliably distinguish screening from diagnostic testing for clients outside age criteria (and lack of consensus on clinical signs/symptoms of CT) Cannot reliably distinguish screening from diagnostic testing for clients outside age criteria (and lack of consensus on clinical signs/symptoms of CT) No unique client identifiers available to identify repeat testers No unique client identifiers available to identify repeat testers Data Source: Region II IPP Prevalence Monitoring Data

15. Measure: CT Screening Coverage in FP Region II Age Group (Years) # of Females Tested # of Female Users Estimated Screening Coverage CY 2005 15-19 51,028 51,028 112,134 112,13445.5% 20-24 67,541 67,541 140,010 140,01048.2% >24 75,895 75,895 190,106 190,10639.9% TOTAL 194,464 194,464 442,250 442,25044.0% CY 2006 15-19 50,614 50,614 110,734 110,73445.7% 20-24 69,288 69,288 140,198 140,19849.4% >24 79,355 79,355 191,509 191,50941.4% TOTAL 199,257 199,257 442,441 442,44145.0% Data Source: FPAR Tables 1 & 11

16. Another Angle: CT Test Utilization in FP Region II Age Group (Years) % of Females Tested % of Female Users Ratio of Tests to Users CY 2005 15-1926%25%1.03 20-2435%32%1.10 >2439%43%0.91 TOTAL100%100%1.00 CY 2006 15-1925%25%1.01 20-2435%32%1.10 >2440%43%0.92 TOTAL100%100%1.00 Data Source: FPAR Tables 1 & 11

17. Measure: CT Screening Coverage in FP Interpretation of data: Interpretation of data: Little, if any, age-based targeting of chlamydia testing is taking place in Region II FP clinics Little, if any, age-based targeting of chlamydia testing is taking place in Region II FP clinics Test utilization in FP by age closely resembles age distribution of users Test utilization in FP by age closely resembles age distribution of users More than 50% of females <25 were not tested More than 50% of females <25 were not tested Data limitations: Data limitations: Cannot reliably distinguish screening from diagnostic testing for clients outside age criteria (and lack of consensus on clinical signs/symptoms of CT) Cannot reliably distinguish screening from diagnostic testing for clients outside age criteria (and lack of consensus on clinical signs/symptoms of CT)

18. Bottom Line: What the Data Tell Us There is both a deficiency in chlamydia screening coverage among the target population of young women AND apparently excessive screening of women over age 25 years. There is both a deficiency in chlamydia screening coverage among the target population of young women AND apparently excessive screening of women over age 25 years.

19. Adherence to Regional Screening Criteria in Relation to Screening Coverage Region II IPP Minimum Screening Criteria for Title X All women ≤ 24 years of age attending a FP clinic for an initial or annual visit will be screened for chlamydia. All women ≤ 24 years of age attending a FP clinic for an initial or annual visit will be screened for chlamydia. Estimated 86% screened as per regional criteria (i.e. contingent on pelvic exam) based on random sample of clients records from 164 FP sites in Region II (N=2,723) Estimated 86% screened as per regional criteria (i.e. contingent on pelvic exam) based on random sample of clients records from 164 FP sites in Region II (N=2,723) However, high adherence to regional criteria translates into low screening coverage (47%) among target population of females <24 years as per FPAR data However, high adherence to regional criteria translates into low screening coverage (47%) among target population of females <24 years as per FPAR data

20. Maximizing Screening Coverage Could resources used to screen women >25 who are not at risk facilitate expanded screening of younger women? Could resources used to screen women >25 who are not at risk facilitate expanded screening of younger women? FP and STD clinics offer many “streamlined” services to young women that do not require a pelvic exam FP and STD clinics offer many “streamlined” services to young women that do not require a pelvic exam Pregnancy test, emergency contraception, HIV testing Pregnancy test, emergency contraception, HIV testing Providing urine-based screening to females ≤25 years who do not undergo a pelvic exam could help increase screening coverage to most at-risk Providing urine-based screening to females ≤25 years who do not undergo a pelvic exam could help increase screening coverage to most at-risk

21. Next Steps for Consideration Replicate studies (e.g. California, Wisconsin) to evaluate the prevalence of CT and risk factors predictive of infection among females >25 yrs Replicate studies (e.g. California, Wisconsin) to evaluate the prevalence of CT and risk factors predictive of infection among females >25 yrs Assess cost-effectiveness of screening programs Assess cost-effectiveness of screening programs Is 3% positivity an appropriate cut-off? Is 3% positivity an appropriate cut-off? Refine/clarify national screening guidelines for females over age 25 years to apply most efficient algorithms Refine/clarify national screening guidelines for females over age 25 years to apply most efficient algorithms Standardize collection of data for risk factors and clinical signs/symptoms to distinguish targeted screening from diagnostic testing Standardize collection of data for risk factors and clinical signs/symptoms to distinguish targeted screening from diagnostic testing

22. Contact Info Kelly Morrison Opdyke, MPH Region II IPP Deputy Coordinator Sr. Program Associate for Special Projects Cicatelli Associates Inc. 505 Eighth Avenue Suite 1601 New York, NY 10018 USA Phone: 212-594-7741 x 250 Email: kopdyke@cicatelli.org kopdyke@cicatelli.org

23. Discussion Q&A