Bugs, Drugs, Dollars and Tests

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Bugs, Drugs, Dollars and Tests

• Making the Most of Scarce Resources for Chlamydia
  and Gonorrhea Screening and Treatment

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Gonorrhea Rates by sex United States,
19812002 and the Healthy People 2010 objective
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Chlamydia - Rates by sex United States, 19842002
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Median Chlamydia and Gonorrhea Positivity among
Women 15-24 tested in Family Planning Clinics
across the US, 2000-2002
Percent
Source CDC Surveillance Reports, 2000-2002
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Median Chlamydia and Gonorrhea Positivity among
Women 16-24 entering the National Job Training
Program, 2000-2002
Percent
Source CDC Surveillance Reports, 2000-2002
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Whats wrong with this picture?
Chlamydia and Gonorrhea Tests
24.1 million CT tests 24.8 million GC tests
Chlamydia Infections
Gonorrhea Infections
Reported 834,555 Estimate 2.8 million
Reported 351,852 Estimate 718,000
Reported To CDC in 2002
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Food for Thought

• Are data driving program funding decisions?
  (cost-effectiveness, prevalence, access, risk)
• How does history/tradition/politics influence
  funding decisions?
• What are our program goals?
• How can programs optimize resource allocation for
  optimal disease intervention?

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• Objectives of the Session
• Present cost effectiveness data of different
  screening and treatment strategies
• Discuss how programs have used data to improve
  screening coverage and increase screening
  criteria adherence
• Demonstrate how screening and cost data can
  influence program strategies and funding
  allocations

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Presenters

• Dorothy Gunter, CDC
• Bartholomew Abban, CDC
• Beth Butler, Pennsylvania DOH
• Bobbie McDonald, Wisconsin State Laboratory of
  Hygiene
• Thomas L. Gift, CDC
• Lisa Schamus, Arizona Family Planning Council
• Charlotte Kent, San Francisco DOPH

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A Unified Optimal Resource Allocation Model for
Screening and Treating Chlamydia Trachomatis and
Neisseria Gonorrhoeae Among Asymptomatic Women

• Bartholomew Abban
• Research Fellow
• Centers for Disease Control and Prevention

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Study Objective

• Determine the optimal combination of screening
  coverage, test selection and treatment for CT and
  GC in asymptomatic women specifically

• At what prevalence is it cost-saving to screen a
  population for CT or GC?
• Is it more beneficial to screen with more
  sensitive but more expensive tests?
• Is presumptive treatment cost-saving?

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Clinical Management Decision
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Clinical Management Decision
Model Variables

• Prevalence, by age group
• Rate of dual infection, by age group
• Test performance parameters and cost
• Treatment efficacy and cost
• Sequelae costs

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Clinical Alternatives Considered
For each risk-group the following strategies are
possible

• Screen and treat for CT only
• Screen and treat for GC only
• Screen and treat for both CT and GC
• Screen and treat for CT only and presumptively
  treat for GC
• Screen for and treat for GC only and
  presumptively treat for CT

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Methods

• The optimal strategy was defined as one that
  maximized
• the number of women cured or
• the cost-saving value (cost of averted PID minus
  screening and treatment costs for CT and/or GC)
• Selective screening based on readily ascertained
  risk-factor Age
• 4 tests each for CT and GC, including dual
  test(s)
• 2 treatment regimens for CT and 3 for GC
• A mixed integer optimization model for a
  hypothetical cohort of 1000 asymptomatic women

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Model Assumptions

• All women who visited the clinic lacked symptoms
  of CT and GC infections
• A strategy could allow the screening of selected
  age groups or all patients
• Return rate for treatment was assumed to be the
  same for all age groups
• Test and treatment for each infection were the
  same for all age groups

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Test Positivity at which Screening is Cost-saving

• Sensitive to PID cost

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Results FP Clinic
CT (2.3 - 10.6), GC (0.4 - 1.2), GC with CT
(30.0 - 46.0)
All costs in US dollars (2003) BDPT Becton
Dickinson Probe Tec Optimal cost-saving
strategy pres. presumptively treat
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Results STD Clinic
CT (3.0 12.5), GC (2.0 8.1), GC with CT
(20.0 45.5)
All costs in US dollars (2003) BDPT Becton
Dickinson Probe Tec Optimal cost-saving
strategy pres. presumptively treat
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Limitations

• The alternative of screening and treating for CT
  and screening CT-positives for GC was not
  considered
• Published range of values for direct cost
  attributable to PID is wide (1,433 5,000)
• Repeat infections were not considered
• STD positivity among asymptomatic women may be
  lower than reported values

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Conclusions

• Optimal control strategy varies with CT and GC
  positivity, CT-GC co-infection rates, total
  program budget, test costs and PID cost
• A switch from one test to another may not yield
  significant change in number of cures
• Influence of treatment cost on overall program
  cost is minimal
• The optimal control strategy from a cost-saving
  perspective and from a number-of-cures
  perspective may vary
• The model provides a flexible tool to analyze
  different scenarios when identifying a control
  strategy for CT, GC or both

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Acknowledgements

• Guoyu Tao
• Tom Gift
• Kathleen L. Irwin
• Dorothy Gunter
• Susan DeLisle

• Stuart Berman
• Susan Wang
• Debra Mosure
• Robert Johnson
• Bobbie McDonald

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To Screen or Not to Screen Pennsylvanias Reality

• Beth Butler
• Infertility Prevention Program Coordinator
• Pennsylvania Department of Health
• STD Program

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A Snapshot of Pennsylvania(exclusive of
Philadelphia)

• The PA Project Area is comprised of STD, Family
  Planning, and Integrated FP/STD clinics
• About 70 of of the STD clinics are integrated
  into Family Planning Sites
• STD Clinics
• Majority of clinics are contracted providers.
• Contracts require patients to be screened for
  gonorrhea, chlamydia, and syphilis
• County and Municipal Health Departments and State
  Health Centers are covered under the same statute

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STD Testing in Pennsylvania

• STD Clinics, County and Municipal Health
  Departments, and Integrated STD Clinic sites
  provide universal testing to STD patients who
  come in for free and confidential STD testing
• Communicable Disease Act in PA
• requires all those who present in an STD Clinic
  to receive STD services

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What the STD Data Demonstrate

• 46,431 females were tested for chlamydia in STD
  clinics in 2002
• 5,624 females over age 30 were tested in STD
  clinics in 2002
• 12.1 of the females tested in STD clinics were
  over 30 years of age

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Female Universal Chlamydia Screening in STD
Clinics (Region III IPP Database 2002)
lt30 40,807 tests 1,724 pos gt30
5,624 tests 79 pos
4.22
3.88
1.40
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Family Planning Screening

• Family Planning clinics participating in the
  Region III Infertility Prevention Project screen
  patients who come into the clinic seeking other
  medical attention (such as birth control and
  annual exam)
• The screening criteria applied to Family Planning
  patient screening is currently
• All women under age 30 who receive a pelvic exam
  should be routinely screened

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What the FP Data Demonstrate

• 79,749 female Family Planning patients were
  screened for chlamydia in 2002
• 10,009 female Family Planning patients over age
  30 were screened in 2002
• 12.5 of the total female Family Planning
  patients screened were beyond the current
  screening criteria

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Female Family Planning Positivity Data (Region
III IPP Database 2002)
Percent
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The Cost of Screening Outside the Screening
Criteria in Family Planning

• 10,009 tests _at_ 11.90 per test 109,107
  (includes all costs associated with analyzing
  amplified CT/GC combination tests at the contract
  lab)
• The positivity in this group is 1.18
• 118 positives were detected
• Increased chance of giving a false positive test
  result

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Cost of Diagnostic Testing

• The goal is to reduce the percentage of screening
  over 30 from its current level of approx 12 to
  5 allowing for diagnostic testing of this
  groupdue to risk factors, clinician discretion,
  and the like
• If only 5 were over 30, approximately 4,000
  specimens would be collected at a cost of 47,600
• Overall testing costs could decrease by 61,507
• The cost savings could be used for screening more
  significantly at risk populations

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Project Area Goals for Screening

• Utilizing Region III IPP Data, reduce the
  screening criteria to under 25 years of age in
  clinics with low positivity (under 1.0) in the
  25-29 year old age range
• Lower the percentage of female patients in family
  planning screened for chlamydia beyond the
  screening criteria to 5

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Why 5 Above the Criteria

• 5 is an initial benchmark for the PA Project
  Area
• It is not feasible to completely cut out
  screening above the criteria
• This allows for clinician discretion and ability
  to make choices for their clients
• Future data will determine where the benchmark
  will go

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Our Process so Far

• Family Planning Agencies have distributed clinic
  by clinic data regarding screening outside the
  criteria to IPP participating clinics
• Training has been conducted by Family Planning
  Agencies to make clinics aware of the costs of
  screening outside the criteria
• Memos have been sent to clinics reminding FP
  clinics to adhere to the screening criteria
• At site visits, the clinicians and managers are
  reminded of the screening criteria

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Examination of Data

• The project area partners met in July 2003 to
  discuss the screening data
• It was found that the 2002 data were
  missing some positives
• The data need to be clean and inclusive before
  it can be used for planning purposes
• The project area partners made a commitment to
  examine data issues and quality assurance of data

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Next Steps

• Review of data collection and reporting practices
  continues
• Family Planning agencies will continue to educate
  clinicians and clinic managers
• The contract between Family Planning and the STD
  Program contains language regarding diagnostic
  testing vs. screening
• Clinics will be required to check off diagnostic
  testing when testing patients in clinic who
  exceed the screening criteria or the clinic will
  be responsible for payment for the test

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What PA Has Learned

• Changing practices will be a slow process
• Prevalence data must be used to demonstrate where
  screening efforts should be focused
• Data must be valid to be used when making
  programmatic changes
• There will always be some screening outside the
  criteria
• The screening criteria in FP cannot at this time
  be put into effect in STD
• All Project Area Partners need to be committed to
  the process

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Chlamydia and Gonorrhea Screening in Wisconsin

• Use of Selective Screening Criteria to Get the
  Most from Limited Resources
• Bobbie McDonald
• Wisconsin State Laboratory of Hygiene

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Development of SSC in WI

• SSC for CT in WI Family Planning since 1980s
• Used locally-derived data to establish SSC
• Age alone identified too many low-risk
  individuals
• Too many total tests (before NAAT)
• Low positivity in many areas
• Universal screening studies with enhanced data
  collection, at selected sites
• Positivity with clinical, demographic, behavioral
  data
• Studies in 1985 (rural, CT-DFA, GC culture) 86
  (urban, GC culture, CT culture, EIA DFA) 1990
  (GC culture, CT EIA/DFA), 1996-97, (CT-EIA, LCR
  PCR) 2001-02 (SDA)

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Standard SSC in WI Family Planning Females

• Chlamydia
• Partner risk (past 90d)
• New partner
• Multiple partners
• Partner w/multiple partners
• Contact
• Symptomatic
• History of STD
• Protocol testing
• Age lt19 (Milwaukee only)
• Added after 1997 study

• Gonorrhea
• Contact
• Symptomatic
• History
• Positive for Chlamydia
• on this specimen
• Note GC criteria not originally based on data
  from this population

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Selective Screening in WI 2002 2003
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Evaluating SSC

• SSC effectiveness can be influenced by changes in
  technology, prevalence, funding, other factors
• Key issue in performing the universal screening
  study in 2002 dual testing for CT- GC
• Technology changes, marketing packages have
  increased GC screening despite low GC prevalence
• Epidemiology of GC varies across state, region
• Major urban area 56.5 of GC testing, 85.6 of
  positivity
• No locally-derived, evidence-based SSC for GC

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2002 Universal Screening Study

• Followed model of previous studies
• Offered testing to all clients in selected
  clinics, with questionnaire analyzed positivity
  data with risk data
• Able to minimize costs
• Previous relationships with clinics, screening
  already established main expense was additional
  testing
• Confirmed that SSC identified highest risk
• Study Positivity, On vs. Off SSC CT 8.4 vs.
  2.9
• GC 3.8 vs. 0.4
• Age criteria alone still inefficient lt26
  identifies 96.4 of infections, by testing 89.2
  of patients
• Efficiently targeting expansion would require use
  of additional data

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Clinic Distribution

• FP clinics in nearly every county in WI
• 43 of 67 rural
• 24 urban, semi-urban
• Study clinics favored urban, semi-urban
• Keep clinic number manageable
• Obtaining enough positive results

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Universal Study CT Data
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Universal Study GC Data
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Updated SSC All FP Sites
Positivity includes all testing Jan 2002 - June
2003 46841 CT tests, 25128 GC tests
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Adherence to SSC

• Cost Incentives criteria is required to obtain a
  no-charge CT or GC test
• SSC recorded on test request form, entered into
  lab data system
• positivity can be monitored by SSC variables
• Reflex GC Testing adding a GC test when CT is
  positive (cases when no other GC SSC is met)
• Identifies a small subset of otherwise low-risk
  patients with a relatively high yield of GC
• Improved buy-in and adherence to GC SSC
• GC Positivity Reflex GC 4.6 (16/348)
• Combo CT-GC 3.2

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Summary Evolution of SSC in WI

• Goal detecting the maximum number of infections
  using available resources
• Decisions about lab test selection and screening
  levels are influenced by many factors
• Resources, technology, prevalence/risk, number of
  patients in need of services, politics/history
• Use of specific, targeted criteria is possible
  and effective
• Simplest criteria (age) not always best
• Differences in epidemiology within program area
• Data, training, incentives can improve buy-in and
  adherence

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The Cost-Effectiveness of Treating Women
Diagnosed with Gonorrhea for Both Gonorrhea and
Chlamydia

• Thomas L. Gift, PhD
• Centers for Disease Control and Prevention

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Routine Dual Treatment

• CDC 2002 Treatment Guidelines
• Dual treatment of women diagnosed with gonorrhea
  (GC) for both GC and chlamydia (CT)
• instead of testing for CT
• can be cost-effective if 10 - 30 of women with
  gonorrhea (GC) also have CT
• Is it also cost-effective to treat women for both
  GC and CT if they are also tested for CT?
• GC test positive, CT test negative

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A Cost-Effectiveness Comparison of Three
Alternatives

• 1) Dual Treatment
• Test women for GC, treat those testing positive
  for both GC and CT
• 2) Test
• Test women for GC and CT, treat based on test
  results
• Treat women positive for GC for GC only
• Treat women positive for CT for CT only
• 3) Test Dual Treatment
• Test women for GC and CT
• Treat women positive for GC for both CT and GC
• Treat women positive for CT for CT only
• Gift et al. Sex Transm Dis. 29542-550, 2002

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Conclusions

• Dual treatment is not a substitute for testing
  for CT in most settings
• If 10 of women with GC also infected with CT,
  dual treatment in addition to testing is
  cost-effective
• Dual treatment will increase over-treatment

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Model Limitations

• Model assumed some form of GC testing in all
  options
• Model did not address whether testing for GC as
  an addition to testing for CT cost-effective

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Screening for CT and GC in Jails

• Model examined three alternatives
• 1) Symptom-based presumptive treatment
• Symptomatic inmates who request treatment treated
  for both CT and GC
• 2) Screen for CT only
• 3) Screen for both CT and GC
• Both screening alternatives assumed nucleic acid
  amplification testing (NAAT) on urine specimens
• 4) Screen for both CT and GC plus dual treatment
• As beforetreat GC positives for both CT GC
• Kraut-Becher, et al. 2004 (unpublished)

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Model Assumptions

• GC prevalence 3
• CT prevalence 8
• 33 of GC-infected inmates also have CT
• 50 of inmates testing positive released before
  treatment
• We assumed no follow-up to ensure treatment with
  those released
• Sequelae costs considered were
• Pelvic inflammatory disease (PID)
• Neonatal pneumonia conjunctivitis for CT
• HIV transmission attributable to GC or CT

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10,000 women
100 with GC CT
700 with CT
200 with GC
564 test
81 test for CT
169 test
19 test - for CT
68 test for GC
16 test for GC

• Not shown
• false positives for GC and CT
• negative results for GC test
• negative results for CT test for women with CT

Half are treated
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10,000 women
100 with GC CT
700 with CT
200 with GC
564 test
81 test for CT
169 test
19 test - for CT
68 test for GC
16 test for GC
9000 uninfected

• Not shown
• false positives for GC and CT
• negative results for GC test
• negative results for CT test for women with CT

49 test for GC
81 test for CT
Half are treated
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Conclusions

• Dual treatment is a cost-saving addition to
  screening for both CT and GC
• Impact is minor, but so is cost
• Among 10,000 women
• 238 women test positive for GC, negative for CT
• 16 are CT-infected, 222 are not CT-infected
• Assuming 50 are treated, 119 treated / 8
  infected
• Is dual treatment cost-saving relative to
  screening for CT only?

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Program and Sequelae Costs in 10,000 Women
All costs 2002 US dollars sequelae include PID,
HIV infections attributable to CT or GC
infection, and neonatal sequelae of CT
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Program and Sequelae Costs in 10,000 Women
All costs 2002 US dollars sequelae include PID,
HIV infections attributable to CT or GC
infection, and neonatal sequelae of CT
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Program and Sequelae Costs in 10,000 Women
All costs 2002 US dollars sequelae include PID,
HIV infections attributable to CT or GC
infection, and neonatal sequelae of CT
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Program and Sequelae Costs in 10,000 Women
All costs 2002 US dollars sequelae include PID,
HIV infections attributable to CT or GC
infection, and neonatal sequelae of CT
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Program and Sequelae Costs in 10,000 Women
Prevalence of CT 6, GC 0.9 33 of those
with GC have CT All costs in 2002 US dollars
(2002)
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Summary Conclusions

• The CDCs dual treatment recommendation
• is cost-saving even when testing separately for
  CT
• on the basis of cost alone, should be considered
  even when GC prevalence is low
• The cost saving from dual treatment is not great
  enough on its own to make screening for GC
  cost-saving at low GC prevalences

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Acknowledgements

• Dual treatment paper authors
• Cathleen Walsh, DrPH
• Anne C. Haddix, PhD
• Kathleen L. Irwin, MD, MPH

• Jail screening manuscript authors
• Julie R. Kraut-Becher, PhD
• Anne C. Haddix, PhD
• Kathleen L. Irwin, MD, MPH
• Robert B. Greifinger, MD

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Screening for Chlamydia in Arizona

• Making the Most of Limited Resources
• Lisa Anne Schamus
• Arizona Family Planning Council

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Outline

• Background of Arizona Infertility Prevention
  Project
• Data Sources
• Historic CT Screening Criteria and Rates
• Clarification of Screening Criteria (in
  1999/2000)
• Changing clinician testing behavior
• Allocation of new resources

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Background of AZ IPP

• Collaborative effort between the Arizona
  Department of Health Services and AZ Family
  Planning Council (Title X)
• CDC Funded Arizona Infertility Prevention Project
  (AZ IPP).
• Started in 1995.
• Title X began with three Sentinel Sites and now
  includes 40 clinics.

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Data Sources

• 1995 to 1999 Logs from sentinel sites.
  Aggregate data for others.
• 2000 Encounter Data from AFPC.
• 2000 Start of electronic data availability from
  lab.
• 2004 Anticipate having lab data for all
  participating clinics for entire year.

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Historic CT and GC Screening Criteria

• Pre 2000 Screening Criteria for AZ IPP
• Screen all women 30 years and younger for
  Chlamydia and test others as indicated.
• Test as indicated for Gonorrhea.

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CT Positivity Rates by Age Groups and Testing
Patterns at 5 Sentinel Sites, 1998
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Step One Change of Screening Criteria for AZ IPP

• Changed screening criteria for AZ IPP in late
  1999
• Screen all female clients 25 and under receiving
  an exam.
• Test others as indicated.

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CT Screening Coverage in Women Receiving an Exam
by Age Group, 2000
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Changing Clinician Screening Practices

• Monitored compliance with screening criteria
  through quarterly reports.
• Provided clinicians and administrators with
  detailed feedback from chart audits
• Provided clinicians and administrators with
  education regarding predictive value of screening
  test in low prevalence populations.

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CT Testing Females 25 and Under Receiving Exams
Q1, 2000 vs. Q1, 2003
84
CT Testing Females 26 and Over Receiving Exams
Q1, 2000 vs. Q1, 2003
85
Percentage of Tests by Age Group, AZ Title X
Family Planning Clinics, 1998 and 2003
Percent
86
ARIZONA IPP FAMILY PLANNINGNUMBER OF FEMALES CT
TESTED AND POSITIVE CASES BY AGE GROUP
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Allocating New Resources

• CDC received increase funding in 2002. Specific
  guidance stated
• The additional IPP funds distributed in 2002 must
  be used to expand chlamydia screening and
  treatment of adolescent and young adult women 25
  years old and younger

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New Screening Criteria, mid-Year 2003

• Screen all female clients 25 years and younger
• Pace II for those receiving an exam
• Aptima for Pregnancy Test Only Clients and others
  not receiving an exam
• Test others as indicated
• Pace II for females receiving exam
• Aptima for all males and for females not
  receiving exam

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Conclusions

• Successes
• Adherence to screening criteria for older
  delegates
• In screening high risk populations
• In detection of CT cases
• Improved data sources

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Conclusions

• Continued Challenges and Future Directions
• Limited resources, desire to provide amplified
  test for all
• Continue to improve adherence to screening
  criteria
• Managed Care/Medicaid

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A Six Year History of Gonorrhea and Chlamydia
Screening GuidelinesSan Francisco STD Clinic

• Charlotte Kent
• San Francisco Department of Public Health

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Why not test everyone who walks in the door? It
is an STD clinic after all!

• Everyones risk of infection might not be the
  same.
• Might want to expand services in some
  sub-populations
• Fixed or decreasing budgets
• Need to use limited resources efficiently

94
San Francisco Background

• One municipal STD clinic
• 2003 21,596 visits
• 17 women, 37 heterosexual men, 46 MSM
• 2002 ranking among 63 U.S. metropolitan areas
• Gonorrhea 28th
• Chlamydia 35th
• Syphilis 1st
• Implemented screening guidelines in 1998 (Ciemens
  et al., STD 2000)

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Diagnostic Testing vs. Screening

• Diagnostic testing
• Symptoms or signs
• Contact to STD
• Currently has an STD
• Screening
• Asymptomatic and no reason for diagnostic testing

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Development of Screening Guidelines - 1998

• Established positivity target
• 2 CT
• 1 GC
• Examined positivity in asymptomatics by age,
  gender/sexual orientation

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1997-1998 Results

• CT prevalence in women older than 30 years lt 2
• GC prevalence in heterosexual men lt 1
• Discontinued screening in these populations
• Reduced GC testing by 16 CT by 6
• Expanded urethral CT screening in MSM

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2000-2001 Results

• GC prevalence lt 1 in women older than 30 years
• Discontinued screening in this population
• Expanded screening in MSM at rectal and
  pharyngeal sites

99
Current Screening Guidelines for MSM

• Urine GC CT NAAT
• Rectal GC CT NAAT, if receptive anal sex last
  six months
• Pharyngeal GC CT NAAT if receptive oral sex
  last two weeks

2003 positivity by site
100
Current Screening Guidelines for Heterosexual Men
2003 positivity by age

• Urine CT NAAT
• 30 and younger only
• Over screening
• 43 (2035/4685) GC
• 54 (1288/2374) CT (gt30 years)

1069
966
n
1922
1288
gt30
lt 30
101
Current Screening Guidelines for Women
2003 positivity by age

• Cervical swab for GC culture or urine for GC NAAT
  if no pelvic
• 30 and younger only
• Urine CT NAAT
• 30 and younger only
• Overscreening - gt30 yrs
• 52 (279/534) GC
• 63 (337/534) CT

872
1001
n
279
337
gt30
lt 30
102
Recommendations

• Areas with low to moderate prevalence of GC CT
  should evaluate the efficiency of testing in STD
  Clinics
• Minimal data needed to develop guidelines
• Reasons for diagnostic testing (symptoms, signs,
  STD contact, etc.)
• Demographics age, gender
• Behavioral who have sex with

103
Recommendations

• Need routine evaluation of guidelines if
  changes in
• Populations seeking services
• Test technology or pricing
• Expansion of specimen type
• Resources
• Non-bundled GC CT tests need to be made
  available by manufactures

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Conclusion

• Feasible to develop, implement modify screening
  guidelines in an STD clinic

105
For More Information

• Dorothy Gunter, DGunter_at_cdc.gov
• Bartholomew Abban, BAbban_at_cdc.gov
• Beth Butler, bebutler_at_state.pa.us
• Bobbie McDonald, Bobbie_at_mail.slh.wisc.edu
• Thomas L. Gift, TGift_at_cdc.gov
• Lisa Schamus, LSchamu_at_ade.az.gov
• Charlotte Kent, Charlotte_Kent_at_dph.sf.ca.us