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Bugs, Drugs, Dollars and Tests

Bugs, Drugs, Dollars and Tests. Making the Most of Scarce Resources for Chlamydia and Gonorrhea Screening and Treatment. Gonorrhea

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Bugs, Drugs, Dollars and Tests

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    2. Bugs, Drugs, Dollars and Tests Making the Most of Scarce Resources for Chlamydia and Gonorrhea Screening and Treatment

    3. Gonorrhea — Rates by sex: United States, 1981–2002 and the Healthy People 2010 objective I want to first introduce some surveillance data to set the stage for our presentations today. This is the typical graph we are accustomed to seeing regarding the nice decline of GC over time. The gonorrhea prevention and control program has had a great deal of success since it was introduced in the early 70s. The current plateau in declining disease since 1997 indicates a need to enhance and target activities for more effective control but generally, the program has been quite effective in initiating and sustaining decreases in population prevalence over time.I want to first introduce some surveillance data to set the stage for our presentations today. This is the typical graph we are accustomed to seeing regarding the nice decline of GC over time. The gonorrhea prevention and control program has had a great deal of success since it was introduced in the early 70s. The current plateau in declining disease since 1997 indicates a need to enhance and target activities for more effective control but generally, the program has been quite effective in initiating and sustaining decreases in population prevalence over time.

    4. Chlamydia - Rates by sex: United States, 1984–2002 Unlike gonorrhea, rates of chlamydia have continued to increase each year since CDC began collecting case reports in 1984. However, it wasn’t until 2000 that all 50 states required the reporting of CT cases to the CDC. We can expect chlamydia rates to continue to increase as more providers screen, more sensitive tests are used, and reporting of cases improve. But case rates of CT and GC provide only part of the disease monitoring picture.Unlike gonorrhea, rates of chlamydia have continued to increase each year since CDC began collecting case reports in 1984. However, it wasn’t until 2000 that all 50 states required the reporting of CT cases to the CDC. We can expect chlamydia rates to continue to increase as more providers screen, more sensitive tests are used, and reporting of cases improve. But case rates of CT and GC provide only part of the disease monitoring picture.

    5. Median Chlamydia and Gonorrhea Positivity among Women 15-24 tested in Family Planning Clinics across the US, 2000-2002 In 1988, as part of the Infertility Prevention Demonstration Project, CDC implemented the Chlamydia Prevalence Monitoring Surveillance Project. As the infertility project and laboratory testing have evolved, both CT and GC positivity data are being submitted to CDC from Regional IPP projects where dual testing is occurring. This slide demonstrates part of the dilemma facing programs today. Between 2000 and 2002, data from family planning clinics that SCREENED women aged 15-24 years shows that the median CT positivity was consistently above 5 % and at least 4 x the GC positivity. GC on the other hand had a median positivity less then 1%. Programs that are dually SCREENING despite this low ***positivity*** are possibly spending thousands of dollars more than necessary and possibly telling women that they have GC when in fact they don’t, since the positive predictive value of the GC test in such a low prevalence population is probably low. In 1988, as part of the Infertility Prevention Demonstration Project, CDC implemented the Chlamydia Prevalence Monitoring Surveillance Project. As the infertility project and laboratory testing have evolved, both CT and GC positivity data are being submitted to CDC from Regional IPP projects where dual testing is occurring. This slide demonstrates part of the dilemma facing programs today. Between 2000 and 2002, data from family planning clinics that SCREENED women aged 15-24 years shows that the median CT positivity was consistently above 5 % and at least 4 x the GC positivity. GC on the other hand had a median positivity less then 1%. Programs that are dually SCREENING despite this low ***positivity*** are possibly spending thousands of dollars more than necessary and possibly telling women that they have GC when in fact they don’t, since the positive predictive value of the GC test in such a low prevalence population is probably low.

    6. Median Chlamydia and Gonorrhea Positivity among Women 16-24 entering the National Job Training Program, 2000-2002 However, Gonorrhea positivity is not low in all settings. GC positivity data from the National Job Training Program where women are screened for both GC and CT at entry shows a consistently high GC positivity (> 2%) in this group of young, poor women - Indicating high population prevalence in this high risk population. CT is also very high. However, Gonorrhea positivity is not low in all settings. GC positivity data from the National Job Training Program where women are screened for both GC and CT at entry shows a consistently high GC positivity (> 2%) in this group of young, poor women - Indicating high population prevalence in this high risk population. CT is also very high.

    7. In 2002, over 800,000 CT cases were reported to the CDC continuing the trend of more than double the number of reported GC cases. Yet, we know that at least 24.1 million CT tests and 24.8 million GC tests were sold in the US in 2000 based on a survey of test manufacturers. The yield from these tests – assuming that they were used for testing - indicates a much higher yield from CT screening efforts than for GC. Overall low gonorrhea rates and positivity make it difficult to justify the continuation of broad-based GC screening programs especially in settings with low positivity. However, screening in low yield age groups and clinics continues – including in STD clinics. As shown in the previous slide, data indicate that there are pockets of high gonorrhea prevalence. So how can programs better target resources to access high prevalence CT and GC settings especially when programs may not have any cost incentive to change program activities and dual test technologies may offer no cost incentives to reduce testing in low yield settings? In this era of shrinking state and federal resources, how can programs continue much needed expansion of CT screening programs yet continue the progress made in GC prevention and control?In 2002, over 800,000 CT cases were reported to the CDC continuing the trend of more than double the number of reported GC cases. Yet, we know that at least 24.1 million CT tests and 24.8 million GC tests were sold in the US in 2000 based on a survey of test manufacturers. The yield from these tests – assuming that they were used for testing - indicates a much higher yield from CT screening efforts than for GC. Overall low gonorrhea rates and positivity make it difficult to justify the continuation of broad-based GC screening programs especially in settings with low positivity. However, screening in low yield age groups and clinics continues – including in STD clinics. As shown in the previous slide, data indicate that there are pockets of high gonorrhea prevalence. So how can programs better target resources to access high prevalence CT and GC settings especially when programs may not have any cost incentive to change program activities and dual test technologies may offer no cost incentives to reduce testing in low yield settings? In this era of shrinking state and federal resources, how can programs continue much needed expansion of CT screening programs yet continue the progress made in GC prevention and control?

    8. 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? So, what’s a program to do? Are our funding decisions driven by data such as cost effectiveness, prevalence, access or risk) or are there other factors such as history, tradition, technology, politics driving our priorities? Are our program goals explicit enough to help drive funding decisions – for example is our goal to find all infections, find most infections at the least cost, find the infections that are influencing disease transmission? What are the tradeoffs of each of these goals and is it possible to balance the tension between the public health prevention and control aspect with the individual’s health perspective? How can programs best target and optimize their resources for the greatest public health impact and optimal disease intervention and control? So, what’s a program to do? Are our funding decisions driven by data such as cost effectiveness, prevalence, access or risk) or are there other factors such as history, tradition, technology, politics driving our priorities? Are our program goals explicit enough to help drive funding decisions – for example is our goal to find all infections, find most infections at the least cost, find the infections that are influencing disease transmission? What are the tradeoffs of each of these goals and is it possible to balance the tension between the public health prevention and control aspect with the individual’s health perspective? How can programs best target and optimize their resources for the greatest public health impact and optimal disease intervention and control?

    9. 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 Three main objectives guided the development of this symposium. We wanted to make sure to present data on cost effectiveness of different screening and treatment strategies – the science. And we wanted to discuss how programs are using data to improve screening coverage and increase screening criteria adherence AND demonstrate that programs can and do make program decisions using data. However, the presenters will also identify the challenges that programs face using data to redirect or allocate funds. We know that data alone do not drive program decisions – technology, funding level, program goals/philosophy, history, tradition, politics – all play a part. Three main objectives guided the development of this symposium. We wanted to make sure to present data on cost effectiveness of different screening and treatment strategies – the science. And we wanted to discuss how programs are using data to improve screening coverage and increase screening criteria adherence AND demonstrate that programs can and do make program decisions using data. However, the presenters will also identify the challenges that programs face using data to redirect or allocate funds. We know that data alone do not drive program decisions – technology, funding level, program goals/philosophy, history, tradition, politics – all play a part.

    10. 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 We will not be able to address all of these questions in our presentations. However, our panel line-up which consists of multiple programmatic and scientific disciplines will represent a variety of perspectives. In addition, we hope that these presentations will demonstrate that programs can take actions to optimize resource allocations and that there are many of ways to get the job done. Bartholomew Abban is a CDC fellow in the DSTDP Beth Butler with the PA DOH is a state IPP coordinator Bobbie McDonald, a laboratorian from Wisconsin and the Region V IPP Tom Gift, is an economist within the DSTDP Lisa Schamus, who used to be with the Arizona FPC Charlotte Kent is an epidemiologist with the SF DOPH Each presenter will present for 10 minutes. We will keep questions until the very end of the session so that we make sure all presenters have adequate time. We will not be able to address all of these questions in our presentations. However, our panel line-up which consists of multiple programmatic and scientific disciplines will represent a variety of perspectives. In addition, we hope that these presentations will demonstrate that programs can take actions to optimize resource allocations and that there are many of ways to get the job done. Bartholomew Abban is a CDC fellow in the DSTDP Beth Butler with the PA DOH is a state IPP coordinator Bobbie McDonald, a laboratorian from Wisconsin and the Region V IPP Tom Gift, is an economist within the DSTDP Lisa Schamus, who used to be with the Arizona FPC Charlotte Kent is an epidemiologist with the SF DOPH Each presenter will present for 10 minutes. We will keep questions until the very end of the session so that we make sure all presenters have adequate time.

    12. 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

    13. Study Objective Determine the optimal combination of screening coverage, test selection and treatment for CT and GC in asymptomatic women; specifically For clinics operating on fixed budgets At what parameter levels is it cost effective to include or exclude GC in a CT screening program and vice versa? Amplified tests vrs. Non-amplified tests For clinics operating on fixed budgets At what parameter levels is it cost effective to include or exclude GC in a CT screening program and vice versa? Amplified tests vrs. Non-amplified tests

    16. Clinical Alternatives Considered 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 4) Although it may not be a desirable strategy we still considered it because the outcomes is equivalent to that effected by using Azithromycin to treat4) Although it may not be a desirable strategy we still considered it because the outcomes is equivalent to that effected by using Azithromycin to treat

    17. 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

    18. 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 Better outcomes may be realized by violating if uniform test and treatment condition. In fact non-uniform tests are be used in some placesBetter outcomes may be realized by violating if uniform test and treatment condition. In fact non-uniform tests are be used in some places

    19. Test Positivity at which Screening is Cost-saving

    20. Results – FP Clinic Cohort of 1000 asymptomatic women - PID (68) Cost and outcomes must be carefully examined when a switch from one test to a more sensitive is being considered Although presumptive treatment of GC is not preferred because of drug resistance issues, the strategy is still included because about the same number of GC interventions would occur when Azithromycin is the chosen treatment regimen Cost-benefit when universal screening is done with Pace 2C is comparative to the strategy above: $7569, 44, $5906.Cohort of 1000 asymptomatic women - PID (68) Cost and outcomes must be carefully examined when a switch from one test to a more sensitive is being considered Although presumptive treatment of GC is not preferred because of drug resistance issues, the strategy is still included because about the same number of GC interventions would occur when Azithromycin is the chosen treatment regimen Cost-benefit when universal screening is done with Pace 2C is comparative to the strategy above: $7569, 44, $5906.

    21. Results – STD Clinic

    22. 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 2) Conversely, screen and treat for GC, and screen GC-positives for CT 3) Threshold prevalence values for positive cost benefits is very sensitive to PID cost2) Conversely, screen and treat for GC, and screen GC-positives for CT 3) Threshold prevalence values for positive cost benefits is very sensitive to PID cost

    23. 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 It may be used, among other things, as an evaluation tool for screening programs - providing support for advocacy for additional funding, or otherwise, through the demonstration of screening outcomes of different strategies.It may be used, among other things, as an evaluation tool for screening programs - providing support for advocacy for additional funding, or otherwise, through the demonstration of screening outcomes of different strategies.

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

    26. To Screen or Not to Screen… Pennsylvania’s Reality Beth Butler Infertility Prevention Program Coordinator Pennsylvania Department of Health STD Program

    27. 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 PA has approximately 220 clinics total doing chlamydia testing—this includes STD clinics, FP clinics, integrated sites and screening sites in alternative locations The Family Planning clinics are divided among 4 family planning councils in Pennsylvania—each council is responsible for a regional area of Pennsylvania and the clinics that are within that area In PA we use a contract laboratory to perform the BD probe tec amplified chlamydia and gonorrhea test (cost for both same as if split) The STD Program began contracting with FP before the IPP in order to provide services throughout PA STD testing in PA provides universal testing to meet state statues for anyone requesting STD servicesPA has approximately 220 clinics total doing chlamydia testing—this includes STD clinics, FP clinics, integrated sites and screening sites in alternative locations The Family Planning clinics are divided among 4 family planning councils in Pennsylvania—each council is responsible for a regional area of Pennsylvania and the clinics that are within that area In PA we use a contract laboratory to perform the BD probe tec amplified chlamydia and gonorrhea test (cost for both same as if split) The STD Program began contracting with FP before the IPP in order to provide services throughout PA STD testing in PA provides universal testing to meet state statues for anyone requesting STD services

    28. 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 The communicable disease act is as follows and in contracts with the clinics it is interpreted to serve anyone with all services without limitationsThe communicable disease act is as follows and in contracts with the clinics it is interpreted to serve anyone with all services without limitations

    29. 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

    30. Female Universal Chlamydia Screening in STD Clinics (Region III IPP Database 2002)

    31. 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 Can apply screening criteria to this group of patients—these patients are not just seeking STD clinic services There are approximately 145 FP clinics in PA participating in the Region III IPP…geographically located throughout PA under 4 family planning councilsCan apply screening criteria to this group of patients—these patients are not just seeking STD clinic services There are approximately 145 FP clinics in PA participating in the Region III IPP…geographically located throughout PA under 4 family planning councils

    32. 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

    33. Female Family Planning Positivity Data (Region III IPP Database 2002) For under 30—the range of positivity is 2.24% to 4.88% for an average of 3.61% When we go above 30 the range is somewhat different from a low of 1.03% to a high of 1.18% with the overall positivity in this group 1.18% The total tests under 30 was 69,740 and the number of positives was 2,517 The total tests 30 and over was 10,009 with 118 positivesFor under 30—the range of positivity is 2.24% to 4.88% for an average of 3.61% When we go above 30 the range is somewhat different from a low of 1.03% to a high of 1.18% with the overall positivity in this group 1.18% The total tests under 30 was 69,740 and the number of positives was 2,517 The total tests 30 and over was 10,009 with 118 positives

    34. The Cost of Screening Outside the Screening Criteria in Family Planning 10,009 tests @ $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 Therefore with 10,009 tests over 30 the cost was $109,107 which is only the lab cost Therefore with 10,009 tests over 30 the cost was $109,107 which is only the lab cost

    35. 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 group—due 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 The cost savings will be used to screen patients who come in for only pregnancy testing, expanded use of urine based screening in alternative venues and the list goes onThe cost savings will be used to screen patients who come in for only pregnancy testing, expanded use of urine based screening in alternative venues and the list goes on

    36. 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% The goal to reduce the number of patients to meet the screening criteria is first and foremost—in discussions with our partners it was decided that it would be impossible to expect that all patients could fall into the criteria and that we needed to give clinicians some leeway The second goal is much more difficult because it means change In addition when we examined the data it seemed that not all positives were included and if using positivity we needed to make sure that all of the positives are there…..this is especially true in small clinics where not too many positives are found and they are at greatest chance of having the under 25 criteria applied The goal to reduce the number of patients to meet the screening criteria is first and foremost—in discussions with our partners it was decided that it would be impossible to expect that all patients could fall into the criteria and that we needed to give clinicians some leeway The second goal is much more difficult because it means change In addition when we examined the data it seemed that not all positives were included and if using positivity we needed to make sure that all of the positives are there…..this is especially true in small clinics where not too many positives are found and they are at greatest chance of having the under 25 criteria applied

    37. 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

    38. 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 We have taken a number of steps to make this process work All partners are involved in this issue and continue to be involved Mostly it will be the clinicians that need to make a change….they will need to think twice before using the specimen collector sitting on the counter It is also important that lab slips are completed to their fullest extent The success of this starts in the clinical setting which is difficult with approx 140 FP clinics involvedWe have taken a number of steps to make this process work All partners are involved in this issue and continue to be involved Mostly it will be the clinicians that need to make a change….they will need to think twice before using the specimen collector sitting on the counter It is also important that lab slips are completed to their fullest extent The success of this starts in the clinical setting which is difficult with approx 140 FP clinics involved

    39. 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 PA has a terrific partnership where dialog is terrific We want to make the changes as a group to get the most buy in from all parties Data was found to be an issue Our STD Data Manager has gone out to three of the FP agencies for site visits to discuss data and collection issues to assure positives get into the data basePA has a terrific partnership where dialog is terrific We want to make the changes as a group to get the most buy in from all parties Data was found to be an issue Our STD Data Manager has gone out to three of the FP agencies for site visits to discuss data and collection issues to assure positives get into the data base

    40. 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 The next steps are to engage clinicians in the process…it is the intention to get clinicians to think before they test outside the criteria. The test kit should not be used just because it is available in this age group. The Family Planning Councils are committed to this because the reduction in testing that yields no results will increase the availability of urine based testing for higher risk young women,,,,therefore the language in the contract starting July 2004 includes documentation of diagnostic testing for women over 30---the documentation is required for reimbursement This documentation will be required at the clinic level for clinicians to check off on the laboratory slip…one more way to get the clinician to think about screening the patient before screening someone outside the criteriaThe next steps are to engage clinicians in the process…it is the intention to get clinicians to think before they test outside the criteria. The test kit should not be used just because it is available in this age group. The Family Planning Councils are committed to this because the reduction in testing that yields no results will increase the availability of urine based testing for higher risk young women,,,,therefore the language in the contract starting July 2004 includes documentation of diagnostic testing for women over 30---the documentation is required for reimbursement This documentation will be required at the clinic level for clinicians to check off on the laboratory slip…one more way to get the clinician to think about screening the patient before screening someone outside the criteria

    41. 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

    43. 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 Development and Use of Locally-Derived, Evidence-Based Selective Screening Criteria (SSC) to Get the Most from Limited ResourcesDevelopment and Use of Locally-Derived, Evidence-Based Selective Screening Criteria (SSC) to Get the Most from Limited Resources

    44. Development of SSC in WI SSC for CT in WI Family Planning since 1980’s 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) Repeated universal screening studies in response to technology changes, for example, to examine the feasibility of transition from non-amplified tests to NAAT; also to help guide expansion or ‘contraction’ (re-direction) of screening effortsRepeated universal screening studies in response to technology changes, for example, to examine the feasibility of transition from non-amplified tests to NAAT; also to help guide expansion or ‘contraction’ (re-direction) of screening efforts

    45. “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 <19 (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 Expanded SSC: CT 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 Patient had a partner with symptoms or diagnosis of CT, GC, NGU, epididymitis, or other STD within past 90 days 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 Expanded SSC: GC CONTACT Patient had a partner with symptoms or diagnosis of Chlamydia, GC, NGU, epididymitis, syphilis or PID within past 90 days (confirmed or self-reported) SYMPTOMATIC Cervicitis -mucopurulent discharge (MPC) or friable cervix Current diagnosis of NGU or PID Penile discharge CURRENT POSITIVE CHLAMYDIA Current positive test for Chlamydia on this specimen (mark box on front to request automatic reflex GC test.) HISTORY of STD (note: NOT “Test of Cure”) Diagnosed with GC, Chlamydia, or PID within the past yearExpanded SSC: CT 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 Patient had a partner with symptoms or diagnosis of CT, GC, NGU, epididymitis, or other STD within past 90 days 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 Expanded SSC: GC CONTACT Patient had a partner with symptoms or diagnosis of Chlamydia, GC, NGU, epididymitis, syphilis or PID within past 90 days (confirmed or self-reported) SYMPTOMATIC Cervicitis -mucopurulent discharge (MPC) or friable cervix Current diagnosis of NGU or PID Penile discharge CURRENT POSITIVE CHLAMYDIA Current positive test for Chlamydia on this specimen (mark box on front to request automatic reflex GC test.) HISTORY of STD (note: NOT “Test of Cure”) Diagnosed with GC, Chlamydia, or PID within the past year

    46. Selective Screening in WI: 2002 & 2003* Note that the “off criteria” positivity may seem high, but these are patients that have been selected to be tested, despite not meeting SSC. They may fall just outside one or more criteria, or have another reason for a test. The positivity in this group is still significantly below the positivity of patients meeting criteria. The off-criteria group does not represent all patients who do not meet criteria. Total number of tests and positives: 2002 CT: 30812, 2824+ (9.2%) 2002 GC: 18194, 640+ (3.5%) 2003 CT: 25224, 2459+ (9.7%) (projected year total: 33632, 3278+) 2003 GC: 10013, 458+ (4.6%) (projected year total: 13351, 611+) Note reduction in (projected) GC screening: <5% reduction in # of positives, but 26% reduction in testing. Percentage of tests done within criteria increased, would like to further this trend, but will lose some (minimal) positives. (29 positives lost vs. 4843 tests; at $5 per test that’s $835 per positive in lab costs.) Note that the “off criteria” positivity may seem high, but these are patients that have been selected to be tested, despite not meeting SSC. They may fall just outside one or more criteria, or have another reason for a test. The positivity in this group is still significantly below the positivity of patients meeting criteria. The off-criteria group does not represent all patients who do not meet criteria. Total number of tests and positives: 2002 CT: 30812, 2824+ (9.2%) 2002 GC: 18194, 640+ (3.5%) 2003 CT: 25224, 2459+ (9.7%) (projected year total: 33632, 3278+) 2003 GC: 10013, 458+ (4.6%) (projected year total: 13351, 611+) Note reduction in (projected) GC screening: <5% reduction in # of positives, but 26% reduction in testing. Percentage of tests done within criteria increased, would like to further this trend, but will lose some (minimal) positives. (29 positives lost vs. 4843 tests; at $5 per test that’s $835 per positive in lab costs.)

    47. 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 An important issue driving us in the direction of a repeated Universal Screening Study was the need for evidence-based GC SSC. The way most NAAT are marketed entice people to do GC whether it’s necessary, and we have to “justify” not doing some GC screening, even in low-prevalence settings, because there is a perception that the GC test doesn’t cost much extra. However, we feels strongly that GC screening should not be done in extremely low prevalence areas no matter how cheap it is– the total program cost is not insignificant, and PPV issues can lead to more problems that just the occasional false-positive.An important issue driving us in the direction of a repeated Universal Screening Study was the need for evidence-based GC SSC. The way most NAAT are marketed entice people to do GC whether it’s necessary, and we have to “justify” not doing some GC screening, even in low-prevalence settings, because there is a perception that the GC test doesn’t cost much extra. However, we feels strongly that GC screening should not be done in extremely low prevalence areas no matter how cheap it is– the total program cost is not insignificant, and PPV issues can lead to more problems that just the occasional false-positive.

    48. 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; <26 identifies 96.4% of infections, by testing 89.2% of patients Efficiently targeting expansion would require use of additional data Bullet 1: Study consisted of 10 clinics, 3 urban (Milwaukee), 4 “semi-urban” (Madison, Racine, Kenosha) and 3 rural (Eau Claire, Wis. Rapids, Manitowoc.) Bullet 3: positivity for all study data, rural and urban combined, using “standard SSC” in use immediately prior to the study period. Bullet 4: Age 25 and under is close to universal screening. Bullet 5: Additional data needed to assign new criteria, especially for rural sites. Population, proximity to Milwaukee, CT and GC positivity on and off criteria (routine testing), proportion of off-criteria tests under 19, 23, among other criteria used.Bullet 1: Study consisted of 10 clinics, 3 urban (Milwaukee), 4 “semi-urban” (Madison, Racine, Kenosha) and 3 rural (Eau Claire, Wis. Rapids, Manitowoc.) Bullet 3: positivity for all study data, rural and urban combined, using “standard SSC” in use immediately prior to the study period. Bullet 4: Age 25 and under is close to universal screening. Bullet 5: Additional data needed to assign new criteria, especially for rural sites. Population, proximity to Milwaukee, CT and GC positivity on and off criteria (routine testing), proportion of off-criteria tests under 19, 23, among other criteria used.

    49. 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 Study clinics are seen overlaid on a Population Map of Wisconsin (2000 Census data) Balance stacked to urban, but necessary to keep study affordable. (More rural sites would mean more training, and more testing for far fewer positives.) Study clinics are seen overlaid on a Population Map of Wisconsin (2000 Census data) Balance stacked to urban, but necessary to keep study affordable. (More rural sites would mean more training, and more testing for far fewer positives.)

    50. Universal Study: CT Data All Study data presented is females only. Total number of Study Tests: 6505 #/% CT Positive: 419/ 6.4% Milwaukee: 2707 #/% CT Positive: 229/ 8.5% Non-Milwaukee: 3795 #/% CT Positive: 190/5.0% All Study data presented is females only. Total number of Study Tests: 6505 #/% CT Positive: 419/ 6.4% Milwaukee: 2707 #/% CT Positive: 229/ 8.5% Non-Milwaukee: 3795 #/% CT Positive: 190/5.0%

    51. Universal Study: GC Data Effect of expansion of GC criteria from current level to a level including all patients getting CT tests (using post-study CT criteria). Total number of Study Tests (females): 6502 #/% GC Positive: 120/ 1.8% Milwaukee: 2707 #/% GC Positive: 83/ 3.1% Non-Milwaukee: 3795 #/% GC Positive: 37/ 1.0% (“Semi-urban” only: 3028, 37/1.2%) Effect of expansion of GC criteria from current level to a level including all patients getting CT tests (using post-study CT criteria). Total number of Study Tests (females): 6502 #/% GC Positive: 120/ 1.8% Milwaukee: 2707 #/% GC Positive: 83/ 3.1% Non-Milwaukee: 3795 #/% GC Positive: 37/ 1.0% (“Semi-urban” only: 3028, 37/1.2%)

    52. Updated SSC: All FP Sites Here we have the criteria updates as a result of the universal screening study and the other data considered. Based on our info, we ended up with 4 categories of clinics, based loosely on population characteristics of their cities. “Level 1” GC criteria was the “standard” GC criteria already in use. “Level 2” GC criteria is limited screening based on “known” GC risk, and without general “history of any STD” criteria. The “lines” drawn for expansion of CT and for limiting GC could not be drawn in the same place. (In fact the line for CT was based on affordability of the new criteria more than positivity, and will probably be moved as time and data progresses. This may look complex, but each clinic is only responsible for their own criteria. Clinics with shared staff were kept at the same criteria level whenever possible. Training has been provided and technical support (me/listserv/regular teleconferences) is readily available. In addition, we will be monitoring criteria use and providing feedback to clinics on a regular basis. Level 1 GC: CONTACT Patient had a partner with symptoms or diagnosis of Chlamydia, GC, NGU, epididymitis, syphilis or PID within past 90 days (confirmed or self-reported) SYMPTOMATIC Cervicitis -mucopurulent discharge (MPC) or friable cervix Current diagnosis of NGU or PID Penile discharge CURRENT POSITIVE CHLAMYDIA Current positive test for Chlamydia on this specimen (mark box on front to request automatic reflex GC test.) HISTORY of STD (note: NOT “Test of Cure”) Diagnosed with GC, Chlamydia, or PID within the past year Level 2 GC CONTACT Patient had partner with GC (confirmed or self-reported) SYMPTOMATIC Patient has Discharge suggestive of GC infection CURRENT POSITIVE CHLAMYDIA Current positive test for Chlamydia on this specimen (mark appropriate test request if automatic GC test is desired.)Here we have the criteria updates as a result of the universal screening study and the other data considered. Based on our info, we ended up with 4 categories of clinics, based loosely on population characteristics of their cities. “Level 1” GC criteria was the “standard” GC criteria already in use. “Level 2” GC criteria is limited screening based on “known” GC risk, and without general “history of any STD” criteria. The “lines” drawn for expansion of CT and for limiting GC could not be drawn in the same place. (In fact the line for CT was based on affordability of the new criteria more than positivity, and will probably be moved as time and data progresses. This may look complex, but each clinic is only responsible for their own criteria. Clinics with shared staff were kept at the same criteria level whenever possible. Training has been provided and technical support (me/listserv/regular teleconferences) is readily available. In addition, we will be monitoring criteria use and providing feedback to clinics on a regular basis. Level 1 GC: CONTACT Patient had a partner with symptoms or diagnosis of Chlamydia, GC, NGU, epididymitis, syphilis or PID within past 90 days (confirmed or self-reported) SYMPTOMATIC Cervicitis -mucopurulent discharge (MPC) or friable cervix Current diagnosis of NGU or PID Penile discharge CURRENT POSITIVE CHLAMYDIA Current positive test for Chlamydia on this specimen (mark box on front to request automatic reflex GC test.) HISTORY of STD (note: NOT “Test of Cure”) Diagnosed with GC, Chlamydia, or PID within the past year Level 2 GC CONTACT Patient had partner with GC (confirmed or self-reported) SYMPTOMATIC Patient has Discharge suggestive of GC infection CURRENT POSITIVE CHLAMYDIA Current positive test for Chlamydia on this specimen (mark appropriate test request if automatic GC test is desired.)

    53. 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% We have used several strategies to encourage and improve adherence to SSC. Probably the most important, and the longest-standing, is requiring the submitter to provide the SSC data on the lab form, for each test requesting use of IP/contract funds. (This also provides us with a useful source of data to monitor positivity and other trends.) However, the financial incentive alone is not enough, especially for GC screening. (Please note that we do not intend to completely prevent clinics from testing outside of criteria. SSC only identifies the highest risk individuals; the ones our program can afford to pay for. Infections exist outside criteria, and clinicians have various options for testing outside SSC when warranted.) As was shown on previous slides, while most of the CT screening is being done within SSC, more than half of GC screening is OFF criteria. This is especially ironic, considering the extremely low GC positivity; rural clinics where GC is almost non-existent are among the worst offenders. This may in part be due to the lack of “hard” data on GC analogous to our locally-derived SSC for CT. Reducing low yield GC screening was among the top reasons for doing the recent universal study, in the hopes that evidence based SSC will be more convincing. Making it easier to request a “reflex GC” ; a GC test that is automatically done when the CT is positive, if the patient did not meet CT SSC at the time of the visit, is another strategy that we hope will be helpful in controlling the large proportion of GC tests done off SSC. So far it has been well-received, and the positivity shows that it’s worthwhile. Getting the data and information out to the submitting clinics (over and over, through a variety of venues) is key, and will be the focus of our efforts over the next several months. We have used several strategies to encourage and improve adherence to SSC. Probably the most important, and the longest-standing, is requiring the submitter to provide the SSC data on the lab form, for each test requesting use of IP/contract funds. (This also provides us with a useful source of data to monitor positivity and other trends.) However, the financial incentive alone is not enough, especially for GC screening. (Please note that we do not intend to completely prevent clinics from testing outside of criteria. SSC only identifies the highest risk individuals; the ones our program can afford to pay for. Infections exist outside criteria, and clinicians have various options for testing outside SSC when warranted.) As was shown on previous slides, while most of the CT screening is being done within SSC, more than half of GC screening is OFF criteria. This is especially ironic, considering the extremely low GC positivity; rural clinics where GC is almost non-existent are among the worst offenders. This may in part be due to the lack of “hard” data on GC analogous to our locally-derived SSC for CT. Reducing low yield GC screening was among the top reasons for doing the recent universal study, in the hopes that evidence based SSC will be more convincing. Making it easier to request a “reflex GC” ; a GC test that is automatically done when the CT is positive, if the patient did not meet CT SSC at the time of the visit, is another strategy that we hope will be helpful in controlling the large proportion of GC tests done off SSC. So far it has been well-received, and the positivity shows that it’s worthwhile. Getting the data and information out to the submitting clinics (over and over, through a variety of venues) is key, and will be the focus of our efforts over the next several months.

    54. 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 Goal is and always has been to detect the maximum proportion of the infections that we know are out there, within the funding constraints imposed on the programs. The factors that influence testing algorithms and method selection are not all static or able to be subjected to mathematical formulas or models. In Wisconsin, we have had the advantage of being acutely aware of the need for selective screening since virtually the beginnings of our screening program—it’s a reality that our partners have lived with for a long time. So we might represent a more mature program, one that has evolved more in a certain direction. With that background, we have found that the simplest criteria (often age) is not always best; and that ssc that is more specific, to account for variances in prevalence across a program area; though it appears more complicated, it can be successfully applied. Support in the form of training, data, feedback, and an available contact person in the laboratory have been critical components. Goal is and always has been to detect the maximum proportion of the infections that we know are out there, within the funding constraints imposed on the programs. The factors that influence testing algorithms and method selection are not all static or able to be subjected to mathematical formulas or models. In Wisconsin, we have had the advantage of being acutely aware of the need for selective screening since virtually the beginnings of our screening program—it’s a reality that our partners have lived with for a long time. So we might represent a more mature program, one that has evolved more in a certain direction. With that background, we have found that the simplest criteria (often age) is not always best; and that ssc that is more specific, to account for variances in prevalence across a program area; though it appears more complicated, it can be successfully applied. Support in the form of training, data, feedback, and an available contact person in the laboratory have been critical components.

    56. The Cost-Effectiveness of Treating Women Diagnosed with Gonorrhea for Both Gonorrhea and Chlamydia Thomas L. Gift, PhD Centers for Disease Control and Prevention

    57. 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

    58. 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. 29:542-550, 2002

    59. 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

    60. 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

    61. 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 before—treat GC positives for both CT & GC *Kraut-Becher, et al. 2004 (unpublished)

    62. 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

    65. 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?

    66. Program and Sequelae Costs in 10,000 Women

    71. Summary Conclusions The CDC’s 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

    72. 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

    74. Screening for Chlamydia in Arizona Making the Most of Limited Resources Lisa Anne Schamus Arizona Family Planning Council

    75. 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 Describe Title X.Describe Title X.

    76. 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. This presentation will focus on Title X funded clinics. Title X of the Public Health Service Act was signed into law in 1970 and is America's family planning program. For more than 30 years, Title X has been the nation's major program to reduce unintended pregnancy by providing contraceptive and related reproductive health care services to low-income women. This presentation will focus on Title X funded clinics. Title X of the Public Health Service Act was signed into law in 1970 and is America's family planning program. For more than 30 years, Title X has been the nation's major program to reduce unintended pregnancy by providing contraceptive and related reproductive health care services to low-income women.

    77. 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. 1995 to 1999 we had no information on who we were not testing, only very limited information on those we were testing. We received logs from five of the 25 or 30 participating clinic. These – Logs from ‘sentinel sites’ contained only information on those tested from a very limited number of clinics. We did receive aggregate data for other participating sites from the labs, again just for those tested. 2000 – Encounter Data from AFPC – provides information on test status plus demographics. 2000 – Start of electronic data availability from lab providing test results with demographics for some participating clinics. 2004 – Anticipate having lab data for all participating clinics The combination of lab data containing some demographic data to look at positivity rates by demographic characteristics and encounter data to monitor testing by age group, visit type, exam status, other other characteristics….1995 to 1999 we had no information on who we were not testing, only very limited information on those we were testing. We received logs from five of the 25 or 30 participating clinic. These – Logs from ‘sentinel sites’ contained only information on those tested from a very limited number of clinics. We did receive aggregate data for other participating sites from the labs, again just for those tested. 2000 – Encounter Data from AFPC – provides information on test status plus demographics. 2000 – Start of electronic data availability from lab providing test results with demographics for some participating clinics. 2004 – Anticipate having lab data for all participating clinics The combination of lab data containing some demographic data to look at positivity rates by demographic characteristics and encounter data to monitor testing by age group, visit type, exam status, other other characteristics….

    78. 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. Before calendar year 2000, the screening guidelines for Arizona IPP clinics was to screen all women 30 years and younger for ct and to test others as indicated. However, participating clinics were not closely monitored to see if they were following these guidelines. In the fall of 1999, the Arizona IPP staff reviewed the Region IX IPP guidelines and realized that our region, and indeed the CDC, recommended only screening women 25 and under and targeted testing in others. These recommendations were based on national datat showing that positivity rates are much higher in women 25 and younger than in women over 25. Before calendar year 2000, the screening guidelines for Arizona IPP clinics was to screen all women 30 years and younger for ct and to test others as indicated. However, participating clinics were not closely monitored to see if they were following these guidelines. In the fall of 1999, the Arizona IPP staff reviewed the Region IX IPP guidelines and realized that our region, and indeed the CDC, recommended only screening women 25 and under and targeted testing in others. These recommendations were based on national datat showing that positivity rates are much higher in women 25 and younger than in women over 25.

    79. CT Positivity Rates by Age Groups and Testing Patterns at 5 ‘Sentinel Sites’, 1998 When we looked at positivity rates by age group for our sentinel sites here in Arizona, we saw that our positivity rates mirrored those of the nation. In women under 25, our rates were over 2%, where screening is shown to be cost effective and appropriate with tests such as PACE II, which is what we were using in Arizona. So, we decided to redefine our screening criteria. In 1999, when we decided to take a look at our screening criteria, the only data we had available for looking at testing by age group was the data from our five sentinel sites. These data showed that nearly half of the tests we were doing at Title X funded clinics were in women over 25 years of age. Of the 176 positives found in this group of 4725 tests, 146 (83%) were found in the 24 and under group. When we looked at positivity rates by age group for our sentinel sites here in Arizona, we saw that our positivity rates mirrored those of the nation. In women under 25, our rates were over 2%, where screening is shown to be cost effective and appropriate with tests such as PACE II, which is what we were using in Arizona. So, we decided to redefine our screening criteria. In 1999, when we decided to take a look at our screening criteria, the only data we had available for looking at testing by age group was the data from our five sentinel sites. These data showed that nearly half of the tests we were doing at Title X funded clinics were in women over 25 years of age. Of the 176 positives found in this group of 4725 tests, 146 (83%) were found in the 24 and under group.

    80. 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. Based on the data we looked at in the last two slides, In late 1999, we changed our screening criteria…Based on the data we looked at in the last two slides, In late 1999, we changed our screening criteria…

    81. CT Screening Coverage in Women Receiving an Exam by Age Group, 2000 When we started this process, our delegates were all over the map in terms of their testing behaviors. As you can see, we had one delegate that was actually testing a higher proportion of women OVER 25 then those under 25. Then we had one delegate that was actually doing a great job of targeted testing in ‘older’ women, but clearly needed to do a better job of ‘universal screening’ in the younger population.When we started this process, our delegates were all over the map in terms of their testing behaviors. As you can see, we had one delegate that was actually testing a higher proportion of women OVER 25 then those under 25. Then we had one delegate that was actually doing a great job of targeted testing in ‘older’ women, but clearly needed to do a better job of ‘universal screening’ in the younger population.

    82. 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. Very early in the process of changing our criteria, it became clear that clinicians were not going to change their screening practices without some help from us. So, in order to change clinician screening behavior, we did three things: Monitored compliance with new screening criteria through Quarterly Reports containing a table showing the percentage of female clients receiving an exam who were tested for Chlamydia by age group. Provided clinicians and administrators with detailed feedback from chart audits. This feedback included information on testing rates by age group. Because many of our providers were concerned that they should still be screening women in their 30’s because they felt their populations to be at high risk, we also looked at charts of women over 25 who were tested and looked for documentation of risk factors or signs and symptoms. We were then able to show the delegates that the majority of women over 25 who they were testing did not have documented indication for testing and that there test results were, for the most part negative. I believe that this feedback was one of the more powerful tools we used in changing clinician screening practices. In addition to the quarterly reports and the feed back from the chart audits, we also provided the delegates with information regarding the predictive value of the screening test we were using in low prevalence populations. Very early in the process of changing our criteria, it became clear that clinicians were not going to change their screening practices without some help from us. So, in order to change clinician screening behavior, we did three things: Monitored compliance with new screening criteria through Quarterly Reports containing a table showing the percentage of female clients receiving an exam who were tested for Chlamydia by age group. Provided clinicians and administrators with detailed feedback from chart audits. This feedback included information on testing rates by age group. Because many of our providers were concerned that they should still be screening women in their 30’s because they felt their populations to be at high risk, we also looked at charts of women over 25 who were tested and looked for documentation of risk factors or signs and symptoms. We were then able to show the delegates that the majority of women over 25 who they were testing did not have documented indication for testing and that there test results were, for the most part negative. I believe that this feedback was one of the more powerful tools we used in changing clinician screening practices. In addition to the quarterly reports and the feed back from the chart audits, we also provided the delegates with information regarding the predictive value of the screening test we were using in low prevalence populations.

    83. CT Testing: Females 25 and Under Receiving Exams Q1, 2000 vs. Q1, 2003 All four delegates increased screening in the target population. All four delegates increased screening in the target population.

    84. CT Testing: Females 26 and Over Receiving Exams Q1, 2000 vs. Q1, 2003 One delegate did not move in the direction we were looking for. During this intervention, this delegate changed leadership two times and. One delegate did not move in the direction we were looking for. During this intervention, this delegate changed leadership two times and.

    85. Percentage of Tests by Age Group, AZ Title X Family Planning Clinics, 1998 and 2003 During this time period the number of tests we had information on by age group for the AZ IPP Project increased from under 5,000 to over 31,000. During this time period the number of tests we had information on by age group for the AZ IPP Project increased from under 5,000 to over 31,000.

    86. ARIZONA IPP FAMILY PLANNING* NUMBER OF FEMALES CT TESTED AND POSITIVE CASES BY AGE GROUP

    87. 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 Although these guidance from the CDC was very clear, it was very difficult to implement the guidance due to competing interests of the IPP participants. Some of the delegate representatives felt very strongly that any increase in funding should be used to switch to amplified test technologies. However, we clearly did not have the funds to switch test technologies and even maintain our level of screening, let alone increase screening if we were to use an amplified test for all clients. So, we figured out a way to introduce amplified testing in the state, while still increasing our screening efforts and moving into new, high risk populations. Although these guidance from the CDC was very clear, it was very difficult to implement the guidance due to competing interests of the IPP participants. Some of the delegate representatives felt very strongly that any increase in funding should be used to switch to amplified test technologies. However, we clearly did not have the funds to switch test technologies and even maintain our level of screening, let alone increase screening if we were to use an amplified test for all clients. So, we figured out a way to introduce amplified testing in the state, while still increasing our screening efforts and moving into new, high risk populations.

    88. 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

    89. Conclusions Successes Adherence to screening criteria for ‘older’ delegates In screening high risk populations In detection of CT cases Improved data sources Successes adherence to screening criteria for ‘older’ delegates. in screening high risk populations. in detection of CT cases. Improved data sources. Future Challenges and Directions Working within the confines of limited resources to provide all partners with appropriate screening for their populations. Continue to work with delegates (especially new ones) on adherence to screening criteria. Work with Managed Care/Medicare populations to provide appropriate screening. Successes adherence to screening criteria for ‘older’ delegates. in screening high risk populations. in detection of CT cases. Improved data sources. Future Challenges and Directions Working within the confines of limited resources to provide all partners with appropriate screening for their populations. Continue to work with delegates (especially new ones) on adherence to screening criteria. Work with Managed Care/Medicare populations to provide appropriate screening.

    90. 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 Successes adherence to screening criteria for ‘older’ delegates. in screening high risk populations. in detection of CT cases. Improved data sources. Future Challenges and Directions Working within the confines of limited resources to provide all partners with appropriate screening for their populations. Continue to work with delegates (especially new ones) on adherence to screening criteria. Work with Managed Care/Medicare populations to provide appropriate screening. Successes adherence to screening criteria for ‘older’ delegates. in screening high risk populations. in detection of CT cases. Improved data sources. Future Challenges and Directions Working within the confines of limited resources to provide all partners with appropriate screening for their populations. Continue to work with delegates (especially new ones) on adherence to screening criteria. Work with Managed Care/Medicare populations to provide appropriate screening.

    92. A Six Year History of Gonorrhea and Chlamydia Screening Guidelines: San Francisco STD Clinic Charlotte Kent San Francisco Department of Public Health

    93. Why not test everyone who walks in the door? It is an STD clinic after all! Everyone’s 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)

    95. Diagnostic Testing vs. Screening Diagnostic testing Symptoms or signs Contact to STD Currently has an STD Screening Asymptomatic and no reason for diagnostic testing

    96. Development of Screening Guidelines - 1998 Established positivity target 2% CT 1% GC Examined positivity in asymptomatics by age, gender/sexual orientation

    97. 1997-1998 Results CT prevalence in women older than 30 years < 2% GC prevalence in heterosexual men < 1% Discontinued screening in these populations Reduced GC testing by 16% & CT by 6% Expanded urethral CT screening in MSM

    98. 2000-2001 Results GC prevalence < 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

    100. Current Screening Guidelines for Heterosexual Men Urine CT NAAT 30 and younger only Over screening 43% (2035/4685) GC 54% (1288/2374) CT (>30 years)

    101. Current Screening Guidelines for Women 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 - >30 yrs 52% (279/534) GC 63% (337/534) CT

    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

    104. Conclusion Feasible to develop, implement & modify screening guidelines in an STD clinic

    105. For More Information Dorothy Gunter, DGunter@cdc.gov Bartholomew Abban, BAbban@cdc.gov Beth Butler, bebutler@state.pa.us Bobbie McDonald, Bobbie@mail.slh.wisc.edu Thomas L. Gift, TGift@cdc.gov Lisa Schamus, LSchamu@ade.az.gov Charlotte Kent, Charlotte_Kent@dph.sf.ca.us

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