1. Developing CT Screening Guidelines for Women > Age 25 2008 National STD Prevention Conference Confronting Challenges, Applying Solutions Chicago, Illinois, March 10-13, 2008 Holly Howard, Joan Chow, Melanie Deal, Heidi Bauer, Gail Bolan STD Control Branch California Department of Public Health

2. Background: The Problem “Excessive” chlamydia (CT) screening in populations with low morbidity has implications:  Ineffective use of limited resources  Lowers PPV* leading to a higher % false positive results * Positive predictive value

3. CT Test Volume & Prevalence among Females by Age, FPACT* 2006 *Quest Diagnostics/Unilab: West Hills/Tarzana, Sacramento, San Jose Background: The Problem in CA Overscreening in a Low Prevalence Pop: Women>25 50% Test Volume

4. In an effort to reduce CT screening among CA FP women > age 25… Provide clinicians with targeted CT screening recommendations that are:  clearly defined  evidence-based using CA FP population data Goal

5. Objectives Among non-pregnant women over age 25 seeking family planning services in CA:  Determine predictors of CT infection  Develop sensitive and specific, targeted screening algorithms for CT  Validate the results

6. The CT Risk Factor Study  Objective: Determine predictors of CT infection among non-pregnant women > age 25 seeking FP services

7. The CT Risk Factor Study Study Methods I Study Design: Cross-sectional Site Eligibility Criteria:  Family planning services  Universal CT screening  Diverse levels of CT morbidity across sites Patient Eligibility Criteria:  Female  Sexually Active*  Not pregnant  Age 26-30 * self-report of vaginal sex within the past 12 mos

8. The CT Risk Factor Study Study Methods II: Data Collected & Methods  Self-administered patient questionnaires:  Demographics, relationship status, sexual behavior, STD history  Clinician-completed clinical evaluations:  Reason for visit, birth control, STD exposure, STD history, symptoms, clinical signs & diagnoses, presumptive CT/GC Rx  Laboratory databases:  CT & GC test results

9. Estimates:  Prevalence estimated by test positivity Statistical Analyses:  Crude and adjusted odds ratios measured association of patient factors with CT positivity:  Chi square tests  Unconditional logistic regression Algorithm Development:  Compared sensitivities and PPVs of various combinations of associated factors The CT Risk Factor Study Analytic Methods

10. The CT Risk Factor Study Results : Final Study Sample & Timeline Participating Sites:  9 FP-dedicated clinics (3 CA FP agencies) Study Sample:  1,243 unique clients, age 26-30, with matching CT test results  Avg. CT positivity: 3.1% (range 1.8%-5.0%) Timeline:  May 2003 - Nov 2005

11.  Report of current contact (exposure) to an STD  CT-indicative clinical syndrome diagnosed on exam:  Cervicitis: endocervical discharge (MPC), cervical friability, or cervical inflammation  Pelvic inflammatory disease (PID): Adnexal/uterine tenderness or cervical motion tenderness  New STD (confirmed or presumptively treated) diagnosed in-office on day of visit (trichomoniasis; presumptive HSV, GC, or genital warts; syphilis, HIV) The CT Risk Factor Study Patients Excluded from Screening Cohort: Clinical Indications for CT “Diagnostic Testing”

12. 18 % of CT Cases 82 % of CT Cases CT-tested Participants Age 26-30 N = 1,243 n CT+ = 39 3.1 % CT+ Patients with clinical indications for diagnostic testing: N = 156 n CT+ = 7  STD contacts  Cervicitis or PID  New STD dx 4.5 % CT+ Patients screened for CT: N = 1,087 n CT+ = 32  No STD contact  No cervicitis or PID  No new STD dx 2.9 % CT+ 87 % of Pop. Tested13 % of Pop. Tested The CT Risk Factor Study Results: CT Prevalence & Proportion of Cases by Clinical Presentation ~ Exclusion Criteria Applied to Screening Cohort ~

13. Patients screened for CT: N = 1,087 n CT+ = 32  No STD contact  No cervicitis or PID  No new STD dx 2.9 % CT+

14. Factors associated with CT:  Patient indicated partner(s) possibly had concurrent partners (past 3 or 12 mos) §  More than 1 or 2 partners (past 3 or 12 mos)  BV diagnosis  Married*  In stable relationship (married, engaged or living w/ partner)*  New partner in past 3 mos (p-value = 0.06) The CT Risk Factor Study Summary of Univariate/Multivariate Findings: Women Age 26-30 * Protective against CT infection in univariate analysis § Independently associated with CT in multivariate analysis (p-value <0.05)

15. The CT Risk Factor Study “Partner possible concurrent partners” Actual Question Studied: Q:At anytime within the past 12 months *, did any of your male partners have sex (of any type) with someone else while they were still in a sexual relationship with you? A:  Yes, definitely  Not sure, it is possible  No, it is very unlikely * Also asked about the past 3 months in a separate question. Answers combined

16. The CT Risk Factor Study Key Study Limitations  Convenience sample of clinics  Unknown if results applicable to women > 30  Unmeasured risk factors may also be predictive of CT

17. The Over 25 Targeted CT Screening Evaluation  Objective: Validate results among a broad patient sample representative of CA’s FP population of women > 25

18. The Over 25 Evaluation Methods I: Study Design & Sample Study Design: Case-Control Chart Abstraction Study Sample:  CA IPP CT prevalence monitoring sites active July-Dec 2006 (excluding San Francisco)  Non-pregnant women age 26-44 with IPP data  Cases = all CT-positives (~100)  Controls = random sample of CT-negatives (~400 from total cohort of 2,551)

19. The Over 25 Evaluation Methods II: Data Variables and Analysis Data Variables: Systematically collected; matched to CT Risk Factor Study Analytical Methods:  Statistical analyses, algorithm development, and prevalence estimates = CT Risk Factor Study  Patient characteristic estimates for CT- negative population derived by weighting sample proportions by clinic site

20. The Over 25 Evaluation Results : Final Study Sample Participating Sites:  17/20 IPP prevalence monitoring sites, many performing targeted screening for women >25 – Geographic locations: 1 northern coast, 1 southern border, 3 southeastern, 2 central valley, 9 LA sites – Clinic types: 3 FP-dedicated, 3 FP/STD integrated, 9 community, 2 free clinics Study Sample:  445 unique client charts abstracted – 83 CT-positive clients – 362 CT-negative clients  Avg. CT positivity = 3.2%

21. 29 % of CT Cases 71 % of CT Cases CT-tested Participants Age 26-44 N = 2,634 n CT+ = 83 3.2 % CT+ Patients with clinical indications for CT testing: N = 346 n CT+ = 24  STD contacts  Cervicitis or PID  New STD dx 6.9 % CT+ Patients screened for CT: N = 2,287 n CT+ = 59  No STD contact  No cervicitis or PID  No new STD dx 2.6 % CT+ 87 % of Pop. Tested13 % of Pop. Tested The Over 25 Evaluation Results: CT Prevalence & Proportion of Cases by Clinical Presentation* ~ Exclusion Criteria Applied to Screening Cohort ~ * Based on weighted sample

22. Patients screened for CT: Age 26-44 N = 2,287 n CT+ = 59  No STD contact  No cervicitis or PID  No new STD dx (except GC+) 2.6 % CT+ Patients age 31-44 screened for CT: N = 1,126 n CT+ = 18 1.6 % CT+ Patients age 26-30 screened for CT: N = 1,162 n CT+ = 41 3.5 % CT+

23. Risk factors predictive for CT infection (statistically significant):  Age < 30 (26-30) §  Partners possible concurrent partners (no time frame) §  New partner (2 mos)  Vaginal DC on exam – unknown etiology (not cervicitis, trich, BV, or yeast)  More than 1 partner (12m) (p-value = 0.13) The Over 25 Evaluation Summary of Univariate/Multivariate Findings: Women Age 26-44 § Independently associated with CT in multivariate analysis (p-value <0.05)

24. The CT Risk Factor Study & The Over 25 Evaluation  Objective: Develop sensitive and specific, targeted CT screening algorithms for women > 25

25. % Pop Screened* N = 2,228 % Cases Detected £ N = 59 % CT+ in pop Screened % CT+ in pop not Screened 1.63.55169  Age 26-30 2.36.03558 Current CDC recommendations ¥ :  Multiple ptr (>1 in 12 mos)  New ptr (2 mos)  CT hx (12 mos) 1.47.54481 Current CDC recommendations ¥ plus:  Ptr possible other ptrs Algorithm of Selected Criteria: 02.6100 Universal Screening The Over 25 Evaluation: Age 26-44 02.9100 Universal Screening 1.55.04976 Current CDC recommendations ¥ :  Multiple ptr (>1 in 12 mos)  New ptr (3 mos)  CT hx (12 mos) 0.84.57093 Current CDC recommendations ¥ plus:  Ptr possible other ptrs % Pop Screened N = 1,087 % Cases Detected £ N = 32 Algorithm of Selected Criteria: % CT+ in pop Screened % CT+ in pop not Screened The CT Risk Factor Study: Age 26-30 Results: Performance of Selective Screening Algorithms £ Actual number of cases and screened population varies by algorithm due to missing values ¥ Approximate replication * Abstracted random sample weighted-up to full tested population by site

26. The Over 25 Evaluation Limitations  Clinic sites already targeting CT screening in women > age 25  It was a chart review – ‘nuff said  Weighting techniques provide approximate results

27. CT predictors: 1.Patient indication that a recent partner (past 12 mos) possibly had concurrent partners was a strong predictor 2.Other behavioral predictors included:  New partner in past 2-3 mos  > 1 partners in past 12 mos 3.Younger age, specifically age 26-30, was a strong demographic predictor Targeted screening algorithms: 1.Performance can be objectively measured / compared 2.Choosing the most appropriate algorithm is based on performance plus the priorities / resources of jurisdiction Conclusions: Implications for CT Screening Recommendations for Women > 25

28. Testing based on clear clinical indications:  Current contact (exposure) to any STD  Clinical signs of cervicitis or PID  Newly confirmed or presumptively treated STD dx Targeted Screening based on risk factors:  Partner possible concurrent partners during past 12 mos  More than 1 partner during past 12 mos (more than 2 partners)  New partner during past 3 mos Additional discussion: higher CT risk often associated with younger age – emphasis on prioritizing age 26-30; Local Prevalence >3% may indicate universal screening Retesting: Encourage CT+ clients RTC in 3 mos CA Proposed CT Testing & Screening Recommendations for Non-Pregnant Women > Age 25

29. CADHS-STD Joan Chow, Heidi Bauer, Erika Samoff, Gail Bolan CFHC Melanie Deal, Christy Ngo, Jackie Provost, Rebecca Braun, Lani Pasion And the CPA & LA IPP CT Prevalence Monitoring Clinic Sites For further information, please contact: Holly Howard at Holly.Howard@cdph.ca.gov Acknowledgements Thank you!

30. Extra Slides

33. CA Chlamydia Rates by County, 2005 7/2006 Provisional Data - CA DHS STD Control Branch Rate per 100,000 < 100 100 to 199 200 to 299 300 + Over 20 & Over 25 Site Distributions Over 20 Study: Age 26-30 Over 25 Evaluation: Age 26-44

34. Background: Nation Guidelines Clear guidelines needed to target CT screening in adult women:  National recommendations support “targeted” screening for women over age 24/25 are not well-defined, inconsistent, and/or inefficient:  CDC (2006): screen women over 25 with “risk factors”: new sex partner, multiple sex partners, or recent CT infection (within previous 12 mos).  USPSTF (2006): screen women over age 24 if “at risk”: history of chlamydial or other sexually transmitted infection, new or multiple sexual partners, inconsistent condom use, exchanges sex for money or drugs, African-American or Hispanic ethnicity, incarcerated populations, military recruits, or patients at public sexually transmitted disease clinics.

35. 0.03.1198100 Truncated USPSTF recommendations*:  Multiple ptr (>1 in 12 mos)  New ptr (3 mos)  CT hx (12 mos)  Unmarried  Inconsistent condom use (3 mos) 1.55.04976 Current CDC recommendations*:  Multiple ptr (>1 in 12 mos)  New ptr (3 mos)  CT hx (12 mos) 0.64.66193 Over 20 Study results:  BV  Ptr possible other ptrs (12 mos)  >2 ptrs (12 mos) 02.9100 Universal Screening % CT+ in pop not Screened % CT+ in pop Screened % Pop Screened N = 1,087 % Cases Detected N = 32 Algorithm of Selected Criteria: * Approximate replication The CT Risk Factor Study Results: Performance of Selective Screening Algorithms Age 26-30

36. Summary of Study Differences CT Risk Factor StudyOver 25 Evaluation Study design Cross-sectional: self report, clinician report and lab results Case-Control: chart review Sample population Non-pregnant female patients Age range26-3026-44 # Clinics participating917 Clinic types 8 FP-only and 1 community clinic 3 FP-only, 3 FP/STD integrated, 9 community, 2 free clinics Clinic locations 8 CPA sites (3 central coast, 4 central valley, 2 Sacramento); 1 LA site (Santa Monica) 8 CPA sites (3 San Bern Co., 1 north, 2 southern border, 2 central valley); 9 LA sites (diverse) Clinic CT screening protocol Universal – all agesTargeted in ages > 25 CT prevalenceLow to moderateModerate to high

37. CT Risk Factor Study Partners  CA DHS, STD Control Branch  CA Family Health Council  CA Chlamydia Action Coalition  UCSF Chlamydia Research Laboratory  Planned Parenthood Santa Barbara, Ventura, and San Luis Obispo, Inc.  Planned Parenthood Mar Monte, Inc.  Westside Family Health Center  Health Net Northern CA: Commercial Managed Care  Kaiser Permanente Northern CA  Quest/Unilab  Health Line Laboratory