Background


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“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.”

  • “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.”



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


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


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”:
    • Screening is the only effective mechanism for detecting “silent infections”
    • No Screening = Missing >70% of CT in this population


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


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


The Over 20 Study



The Over 20 Study Research 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


The Over 20 Study Study Methods

  • Patient Eligibility Criteria:

  • Female clients seeking FP services

  • Age 21-30

  • Not pregnant

  • Sexually Active (self-report of vaginal sex in past 12 months)



The Over 20 Study Study 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


The Over 20 Study Results: 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


The Over 20 Study Results: Final Study Sample Study Forms Submitted for Unique, Eligible, CT-Tested Clients* and Successfully Matched with Lab Result Data



The Over 20 Study: Total Sample Results: Demographics Age (Years)



The Over 20 Study: Total Sample Results: Demographics Race/Ethnicity



Patients with Clinical Indications for CT Testing excluded from screening analysis:

  • Report of current contact (exposure) to an STD

  • CT-indicative clinical syndrome diagnosed 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)



The Over 20 Study Results (Age 21-30): CT Prevalence & Proportion of Cases by Clinical Presentation ~Exclusion Criteria Applied to Screening Analysis~





The Over 20 Study Summary 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)



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







The Over 20 Study Key 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





The Over 25 Evaluation: IPP Scantron Data Benefits & 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



The Over 25 Evaluation: IPP Scantron Data Challenges & Limitations

  • Needed some supplemental data not available on forms (e.g., BV status)

  • Forms had never been validated

  • 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


The Over 25 Evaluation: Chart Abstraction Design/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


The Over 25 Evaluation: IPP Scantron Data Validation 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


Summary of Study Differences



CA Chlamydia Rates by County, 2005



The Over 25 Evaluation: Total *Weighted Chart Abstraction Sample Results Total Sample: Age (Years)



Results Total Samples: Race/Ethnicity



The Over 25 Evaluation Results (Age 26-44): CT Prevalence & Proportion of Cases by Clinical Presentation ~Exclusion Criteria Applied to Screening Analysis~





The Over 25 Evaluation Summary 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)



The Over 25 Evaluation Summary 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)



Summary of Cross-Study Statistical Findings: Risk factors predictive of CT infection







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



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



Acknowledgements

  • 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 at hhoward@dhs.ca.gov




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