Roberta (Bobbie) McDonald Wisconsin State Laboratory of Hygiene, Madison, WI

1. Universal Screening to Assess Chlamydia Prevalence and Risk Among Older Women Attending Family Planning Clinics in Wisconsin Roberta (Bobbie) McDonald Wisconsin State Laboratory of Hygiene, Madison, WI Region V Infertility Prevention Project STD Prevention Conference, March 12, 2008 Chicago, IL bobbie@mail.SLH.wisc.edu

2. WI Chlamydia Program History • CT Testing in WI Family Planning clinics since the 1980’s (culture, then EIA/DFA) • Challenges faced in implementing a cohesive screening program • Limited resources available (technology, $) • Little data, no formal recommendations • Diverse population across WI; urban vs. rural • Supporting factors included: • Good relationships between providers, lab & program • Visionary early leadership

3. History of Universal Screening Studies in WI • First ‘Universal Screening’ studies in FP • Established evidence-based screening criteria • Positivity justified continued screening in FP • Universal screening has been revisited in 5-7 year intervals to address: • Changes in test technology and costs • Epidemiology, local data, demographics • National recommendations (age-based)

4. Universal Screening Study Model • Periods of ‘universal’ testing and expanded data collection in a representative subset of family planning clinics • Test results matched with patient and clinician questionnaire data (behavioral, demographic and clinical risk factors) • Often used as an opportunity to examine other program issues (assay performance comparisons, specimen validation, etc.)

5. History of Universal Screening Studies in WI • Universal screening studies in WI FP: • 1985(rural, CT-DFA, GC culture) • 1986 (urban, GC & CT culture, EIA & DFA) • 1990 (GC culture, CT EIA/DFA) • 1996-97 (CT-EIA, LCR & PCR) • 2001-02 (SDA, males & females, CT and GC) • Data analysis in these studies led to our ‘risk-first’ approach • In all studies, age was examined as a risk criterion; added as SSC selectively in 2002

6. 2001 Universal Screening Data • 8,108 female patients (10 clinics, 7 mos.) • 6,572 participants (81%) w/ complete data • 4908 (74.7%) age 25 and under • 7.7% CT positive overall • 87.5% meet SSC, 8.2% CT positive • 12.5% of tests outside SSC, 4.4% CT positive • 1664 (25.3%) age 26 and over • 2.7% CT positive overall • 86.5% meet SSC, 2.8% positive • 13.5% of tests outside SSC, 1.8% CT positive

7. 2001 Universal Screening Analysis

8. Milwaukee vs. Non-Milwaukee

9. “Drawing the Line” for SSC • Balance positivity, recommendations, risk factors, and various cost measures with the bottom line program budget • Consider limitations of study (sample size, participation rate, urban bias • State “politics” may also come into play! • SSC must be simple enough to use, and accurate enough that it will be used, while effectively targeting program funds

10. Current SSC in WI FP (2002) • SEX PARTNER RISK: All within past 90 days • Patient had more than one partner • Patient had a partner who had more than one partner • Patient had a new partner • CONTACT: within past 90 days • Partner w/ symptoms or diagnosis of CT, GC, NGU, epididymitis, or other STD • SYMPTOMATIC • Current diagnosis of (or evaluation for) gonorrhea • Current diagnosis of or symptoms of PID • Cervicitis - mucopurulent discharge or friable cervix • Cervical erythema greater than 50% • Purulent vaginal discharge • HISTORY of STD (note: NOT “Test of Cure”) • Confirmed or self-reported CT infection in past 5 years • OTHER • Protocol testing: Prior to an IUD insertion • Pregnancy - prenatal visit • SPECIAL AGE CRITERIA • Patients not meeting above criteria, but under a specified age may be tested using contract funds in selected clinics. (<19 semi-urban, <23 Milwaukee)

11. Universal Screening Studies: Impact on Routine • Routine testing data re SSC is gathered on the lab form • Contract (IPP) funds available only for tests meeting SSC • Age criteria is assigned to each clinic based on data • Patients tested outside of SSC are selected by clinician for various reasons

12. Universal vs. Routine Screening 2001 Universal Screening Study Females 2001 Universal Screening Study Females • Age distribution quite similar • Reduction in tests over age 25 in 2006 compared to universal (20% of tests vs. 25%) • Alternate funding sources for CT testing play a role Age 2006 Routine Screening, Females, by Age 2006 Routine Screening, Females, by Age Age

13. 2006 Routine Testing Data • 39,107 female patients (~70 clinics) • 31,110 (79.6%) age 25 and under • 7.9% CT positive overall • 85.8% meet SSC, 8.6% CT positive • 14.2% of tests outside SSC, 4.3% CT positive • 7997 (20.4%) age 26 and over • 3.3% CT positive overall • 84.6% meet SSC, 3.6% positive • 15.4% of tests outside SSC, 1.9% CT positive

14. 2006 Routine Testing by Age

15. 2006 Routine Screening, Age >25

16. 2006 CT Positivity by Location, Age • In general, positivity on SSC is about double the off-SSC rate • CT positivity in Milwaukee has always been strikingly higher than the rest of WI • Off-SSC CT rates are uniformly low in women over 25 across all of WI! 2006 Positivity by Location, Age, SSC

17. 2008 Universal Screening Study Current Critical Challenges • Always needing to do more with less! • Impact of FP MA waiver (free testing w/o requirement of meeting SSC) • Convince clinicians not to test low-risk older women when there is funding they can access? • Increased emphasis on reducing screening in older women (>25? >30?) • Reducing low-yield off-SSC testing in all age groups

18. 2008 Universal Screening Goals • Increase participation towards “Universal” • Clinic-based (NP) Study Coordinator • Better training for clinic staff, more follow-up • Streamline clinic procedures • Improve questionnaire, simplify questions • Clinicians provided input into potential new criteria questions • Assess specific reasons for off-SSC testing…

19. “Clinician Impression” Questions • Does patient meet current screening criteria?  Yes  No • If NO, would you be inclined to test patient outside criteria?  Yes  No • If yes, Why? (mark any/all that apply) • risks outside the 3-month timeframe • reliability of history information provided • other reason (specify)______________________________________________ _________________________________________________________ • Rate your impression of patient’s overall STD risk from 1 (very low) to 5 (very high): 1 2 3 4 5 • Rate your impression of patient’s overall health from 1 (very good) to 5 (very poor): 1 2 3 4 5

20. Summary: CT Screening in WI Women > 25 • Universal screening studies can provide data needed to support use of SSC • WI’s locally-derived SSC identifies women over age 25 at increased risk of CT infection in WI FP • Women over 25 without risk criteria are a small portion of CT tests, with low positivity (=/< 2%), even in high-prevalence areas

21. Lessons from The WI Experience • Using local data to determine SSC may require different criteria for different areas • More complex for the program, more effective • Each clinic has only one set of SSC to follow • Financial incentives can help compliance • Alternate sources of funding can complicate SSC use and the ability to monitor • Provider behavior can be changed, slowly