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Developing CT Screening Guidelines for Women >25: The Over 20 Study & The Over 25 Evaluation

Developing CT Screening Guidelines for Women >25: The Over 20 Study & The Over 25 Evaluation. Region II IPP Meeting NYC, NY May 17, 2007.

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Developing CT Screening Guidelines for Women >25: The Over 20 Study & The Over 25 Evaluation

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  1. Developing CT Screening Guidelines for Women >25: The Over 20 Study & The Over 25 Evaluation Region II IPP Meeting NYC, NY May 17, 2007

  2. “An evaluation of the performance/appropriateness of national chlamydia (CT) screening guidelines when applied to non-pregnant adult women seeking family planning services in California.”

  3. Background: The Problem “Excessive” CT screening in populations with low CT morbidity has implications: • Not an effective use of limited resources • CA uses 3% as cost-effective cut-off • May lead to a higher proportion of false positive test results

  4. Background: The Problem (CA) Among adult women, CA FP setting has relatively low CT rates but high volume of screening: • Significantly less CT in women age >25 than in younger women, yet screening rates are similar • Almost 50% of all screening occurs in this older age-group • CT prevalence in this population >25 is <3% • CT rates for women age 21-25 <3% in some areas

  5. Background: Why Not Stop Screening Older Women Altogether? • Detecting/treating CT infections has been shown to reduce such adverse sequelae as PID, infertility • The vast majority of CT infections in all women, including women >25, are asymptomatic or “silent”: • Over 70% of CT in women >25 do not present with clear clinical indications for testing • Screening is the only effective mechanism for detecting “silent infections” No Screening = Missing >70% of CT in this population

  6. Background: The Solution: Targeted Screening Evidence-based targeted screening strategies: • Can identify a sub-population with higher CT % • A balance between saving resources and still reducing the burden of CT in lower-prevalence populations TS!

  7. Background:Who to Target? Clear guidelines needed to target CT screening in adult women: • Though national recommendations support targeted screening for women >25, they are: • Not well-defined • Inconsistent, and/or • Inefficient

  8. The Over 20 Study

  9. The Over 20 StudyResearch Objectives Among non-pregnant women age 21-30 seeking family planning services: • Determine predictors of CT infection • Develop efficient targeted screening strategies for CT infection, specifically in women >25 • Determine whether targeted screening is appropriate for the population of women 21-25

  10. The Over 20 StudyStudy Methods Study Design:Cross-sectional Patient Eligibility Criteria: • Female clients seeking FP services • Age 21-30 • Not pregnant • Sexually Active (self-report of vaginal sex in past 12 months)

  11. The Over 20 StudyStudy Methods Data collected & methods: • Self-administered patient questionnaires: • Demographics, relationship status, sexual behavior, STD history • Clinician-completed clinical evaluations: • Reason for visit, birth control, STD contact, STD history, symptoms, clinical signs & diagnoses, presumptive CT/GC Rx • Laboratory databases: • CT & GC test results

  12. The Over 20 StudyResults: Participating Agencies & Project Timeline • Participating Sites: • 9 clinics (3 CA FP agencies) all performing universal screening • Timeline: two phases • May 2003 to May 2004 • August 2004 to November 2005

  13. The Over 20 StudyResults: Final Study SampleStudy Forms Submitted forUnique, Eligible, CT-Tested Clients* and Successfully Matched with Lab Result Data * = Age 21-30 years

  14. CT Positives n = 180 The Over 20 Study: Total Sample Results: DemographicsAge (Years) CT Tested N = 4,292

  15. CT Positives n = 180 The Over 20 Study: Total SampleResults: DemographicsRace/Ethnicity CT Tested N = 4,292

  16. Patients with Clinical Indications for CT Testing excluded from screening analysis: • Report of current contact (exposure) to an STD • CT-indicative clinical syndromediagnosed on exam: • Cervicitis: endocervical discharge, 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)

  17. The Over 20 Study Results (Age 21-30):CT Prevalence & Proportion of Cases by Clinical Presentation~Exclusion Criteria Applied to Screening Analysis~ Total CT-tested Participants N = 4,292 nCT+ = 180 4.2 % CT+ • Patients with clinical • indications for CT testing: • N = 550 nCT+ = 48 • STD contacts • Cervicitis or PID • New STD dx 8.7 % CT+ • Patients screened for CT: • N = 3,742 nCT+ = 132 • No STD contact • No cervicitis or PID • No new STD dx • 3.5 % CT+ 27 % of CT Cases 73 % of CT Cases 13 % of Pop. Tested 87 % of Pop. Tested

  18. CT Prevalence >3% justifies universal screening • Patients screened for CT: • N = 3,742 nCT+ = 132 • No STD contact • No cervicitis or PID • No new STD dx (except GC+) • 3.5 % CT+ Patients age 21-25 screened for CT: N = 2655nCT+ = 100 3.8 % CT+ Patients age 26-30 screened for CT: N = 1,087nCT+ = 32 2.9 % CT+

  19. The Over 20 StudySummary of Univariate Findings:Women age 26-30 years Risk factors predictive or protective for CT infection (statistically significantly): • Partners possible other partners (3 or 12 mos)§ • More than 1 or 2 partners (3 or 12 mos) • BV • Married* • Stable relationship (married, engaged or living with partner)* • New partner in past 3 mos (p-value = 0.06) * Protective against CT infection in univariate analysis § Independently associated with CT in multivariate analysis (p-value <0.05)

  20. The Over 20 Study“Partner possible other 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 Answers combined * Also asked about the past 3 months in a separate question.

  21. The Over 20 Study: Screening AnalysisResults: Performance of Selective Screening AlgorithmsAge 26-30 Algorithm of Selected Criteria: % Cases DetectedN = 32 % Pop ScreenedN = 1,087 % CT+ in pop Screened % CT+ in pop not Screened Universal Screening 100 100 2.9 0 • BV • Ptr possible other ptrs • New Partner in 3 mos • >2 Ptr in 12 mos • Stable Relationship 79 38 35 39 75 23 50 46 16 13 8.7 5.1 5.4 4.9 4.4 1.1 2.4 2.1 2.0 1.5 • >1 Ptr in 12 mos 50 32 4.8 2.3

  22. The Over 20 Study: Screening AnalysisResults: Performance of Selective Screening AlgorithmsAge 26-30 Algorithm of Selected Criteria: % Cases DetectedN = 32 % Pop ScreenedN = 1,087 % CT+ in pop Screened % CT+ in pop not Screened Universal Screening 100 100 2.9 0 Current CDC recommendations*: • Multiple ptr (>1 in 12 mos) • New ptr (3 mos) • CT hx (12 mos) 76 49 5.0 1.5 Current USPSTF recommendations*: • Multiple ptr (>1 in 12 mos) • New ptr (3 mos) • CT hx (12 mos) • Unmarried • Inconsistent condom use (3 mos) 100 98 3.11 0.0 Over 20 Study results: • BV • Ptr possible other ptrs (12 mos) • >2 ptrs (12 mos) 93 61 4.6 0.6 * Approximate replication

  23. The Over 20 StudyKey Study Limitations • Convenience sample of clinics mostly located on California’s central coast and in the central valley -- may not be representative of overall CA FP population • Unknown if results applicable to women > 30

  24. The Over 25 Evaluation • IPP Scantron Data • Chart Abstraction

  25. The Over 25 Evaluation: IPP Scantron DataBenefits & Strengths Can use existing IPP data collected via Scantron forms (~3,000) from CA Project Area and Los Angeles CT prevalence monitoring sites: • Scantron forms newly revised 7/06 with influence from Over 20 Study result – similar data • CPA and LA Scantron forms now identical • ~ 20 geographically diverse clinic sites across CA • Data collected from CT-tested patients of all ages

  26. The Over 25 Evaluation: IPP Scantron DataChallenges & Limitations • Needed some supplemental data not available on forms (e.g., BV status) • Forms had never beenvalidated • Clinic sites already targeting CT screening in women > age 25 -- data bias • May give inflated prevalence rates • May underestimate associations between risk factors and CT • % of population screened in algorithms may not be accurate

  27. The Over 25 Evaluation: Chart AbstractionDesign/Methods Design: Case-Control Chart Abstraction Use Scantron forms to pull sample of medical record charts for abstraction: • All CT-positive patients (~100) • A random-sample of CT-negative patients, chosen by clinic site, using a 4 negatives:1 positive ratio (~400) • Collect supplemental data for research purposes • Collect identical data, as possible, for validation purposes

  28. The Over 25 Evaluation: IPP Scantron DataValidation Results • Successfully abstracted 82% of sample goal (446/544 charts in total; 83/100 CT+ charts): • ~ 8% pregnant • ~ 1.5% males • Other issues: wrong DOBs – out of eligible age range; clients not tested for CT; missing charts • Data concordance: • Demographics/other core variables: > 90% • Lab data: > 95% • CT symptoms: 96% of No’s / 33% of Yes’s • Clinical data: 96% of No’s / 38% of Yes’s • Behavioral data: 60-97% of No’s / 38-60% of Yes’s

  29. Over 20 Study Over 25 Evaluation Summary of Study Differences

  30. Over 20 Study: Age 26-30 Rate per100,000 < 100 100 to 199 Over 25 Evaluation: Age 26-44 200 to 299 300 + Over 20 & Over 25Site Distributions CA Chlamydia Rates by County, 2005 7/2006 Provisional Data - CA DHS STD Control Branch

  31. CT Positives n = 83 The Over 25 Evaluation: Total *Weighted Chart Abstraction Sample Results Total Sample: Age (Years) CT Tested N = 2,634*

  32. Results Total Samples: Race/Ethnicity CT Positives CT Tested Over 20 Study N = 4,292 n = 180 Over 25 Evaluation * Weighted sample N = 2,616* n = 83

  33. The Over 25 Evaluation Results (Age 26-44):CT Prevalence & Proportion of Cases by Clinical Presentation~Exclusion Criteria Applied to Screening Analysis~ Total CT-tested Participants N = 2,634 nCT+ = 83 3.2 % CT+ • Patients with clinical • indications for CT testing: • N = 346 nCT+ = 24 • STD contacts • Cervicitis or PID • New STD dx 6.9 % CT+ • Patients screened for CT: • N = 2,287 nCT+ = 59 • No STD contact • No cervicitis or PID • No new STD dx • 2.6 % CT+ 29 % of CT Cases 71 % of CT Cases 13 % of Pop. Tested 87 % of Pop. Tested

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

  35. The Over 25 EvaluationSummary of Univariate/Multivariate Findings:Women age Over 25 (26-44) Risk factors predictive for CT infection (statistically significantly): • Age < 30 (26-30)§ • Partners possible other 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) • Complaints of pain or bleeding with sex, pelvic pain, or spotting (p-value = 0.18) • Asian race (p-value = 0.18) § Independently associated with CT in multivariate analysis (p-value <0.05)

  36. The Over 25 EvaluationSummary of Univariate/Multivariate Findings:Women age Over 30 (31-44) Risk factors predictive for CT infection: • Age < 35 (31-35) (p-value = 0.12) • Partners possible other partners (no timeframe) (p-value = 0.26)

  37. Summary of Cross-Study Statistical Findings:Risk factors predictive of CT infection Over 25 EvalAge 26-44 Over 20 StudyAge 26-30 Predictive Risk Factor

  38. The Over 20 Study: Screening AnalysisResults: Performance of Selective Screening AlgorithmsAge > 25 (26-30) Algorithm of Selected Criteria: % Cases Detected£N = 32 % Pop Screened£N = 1,087 % CT+ in pop Screened % CT+ in pop not Screened Universal Screening 100 100 2.9 0 Current CDC recommendations±: • Multiple ptr (>1 in 12 mos) • New ptr (2 mos) • CT hx (12 mos) 76 49 5.0 1.5 Current CDC recommendations± plus: • Ptr possible other ptrs 93 70 4.5 0.8 Current CDC recommendations± plus: • Ptr possible other ptrs • BV Current CDC recommendations± plus: • Ptr possible other ptrs • Vaginal DC-no known etiology Current CDC recommendations± plus: • Ptr possible other ptrs • Vaginal DC-no known etiology • BV 96 96 96 79 75 78 4.4 4.2 4.2 0.5 0.6 0.6 £ Actual number of cases and screened population varies by algorithm due to missing values ± Approximate replication

  39. The Over 25 Evaluation: Weighted Screening AnalysisResults: Performance of Selective Screening AlgorithmsAge > 25 (26-44) Algorithm of Selected Criteria: % Cases Detected£N = 59 % Pop Screened*N = 2,228 % CT+ in pop Screened % CT+ in pop not Screened • Age 26-30 69 51 3.5 1.6 Universal Screening 100 100 2.6 0 Current CDC recommendations±: • Multiple ptr (>1 in 12 mos) • New ptr (2 mos) • CT hx (12 mos) 58 35 6.0 2.3 Current CDC recommendations± plus: • Ptr possible other ptrs 81 44 7.5 1.4 Current CDC recommendations± plus: • Ptr possible other ptrs • BV Current CDC recommendations± plus: • Ptr possible other ptrs • Vaginal DC-no known etiology • BV Current CDC recommendations± plus: • Ptr possible other ptrs • Vaginal DC-no known etiology 87 90 88 52 70 73 4.7 7.4 4.9 1.1 1.7 1.4 £ Actual number of cases and screened population varies by algorithm due to missing values * Abstracted random sample weighted-up to full tested population by site ± Approximate replication

  40. Implications for Screening Recommendations for Non-Pregnant Women > Age 25 • Partner(s) possibly having had other concurrent partners (during past 12 mos) was the strongest predictor of CT in these research projects; • Other fairly consistent behavioral predictors of CT included: • > 1 partners in past 12 mos • New partner in past 2-3 mos • Younger age, specifically age 26-30, was a strong demographic predictor of CT • Possible clinical predictors include: BV and Vaginal DC on exam with no known etiology

  41. Proposed CT Testing & Screening Recommendations for Non-Pregnant Women > Age 25 • Testing based on clear clinical indications: • Current contact (exposure) to any STD • Clinical signs of cervicitis or PID • Newly confirmed or presumptively treated other STD dx ? Additional discussion about other clinical considerations for clinician discretion: • Vaginal DC on exam with unknown etiology (cervicitis?) • BV dx in some populations • Retesting: Encourage CT+ clients RTC in 3 mos • Targeted Screening based on risk factors: • Partner possible other partners during past 12 mos!!! • More than 1 partner during past 12 mos (more than 2 partners) • New partner during past 2-3 mos • Additional discussion: higher CT risk often associated with younger age – emphasis on prioritizing age 26-30

  42. Acknowledgements Thank you! CADHS-STD Joan Chow, Heidi Bauer, Erika Samoff, Gail Bolan CFHC Melanie Deal, Christy Ngo, Jackie Provost, Rebecca Braun, Lani Pasion Lab Partners Quest Diagnostics, Medical Group Pathology Laboratory, UCSF Chlamydia Research Laboratory (Julius Schachter), Planned Parenthood Mar Monte Laboratory (Jill A. MacAfee) And all The Over 20 & Over 25 Participating Clinic Sites For further information, please contact: Holly Howard athhoward@dhs.ca.gov

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