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Assessing Linkage to Care by Linking Prescription
  Filling Records from an AIDS Drug Assistance
  Program to Laboratory Results from HIV/AIDS
        Reporting System in Washington DC.
Gurung DK1, Bayone S1, Freehill G1, Griffin A1, Samala R1, Wu
 C1, Rangarajan S2,3, Hader S1, Kamanu Elias N1, Weidle PJ3

  1HIV/AIDS,  Hepatitis, STD & TB Administration (HAHSTA), District of
 Columbia Department of Health, Government of the District of Columbia,
                            Washington, DC.
           2 Satyam Computer Services Limited, Atlanta, GA.

          3Division of HIV/AIDS Prevention, CDC, Atlanta, GA.

           Disclaimer: The findings and conclusions in this presentation are those of the authors and do not
           necessarily represent the views of the Centers for Disease Control and Prevention or the DC Department
           of Health.
Background
 The National AIDS Drug Assistance Program (ADAP) of
  the Ryan White Comprehensive AIDS Resources
  Emergency Act.
    Source of prescription drugs for people with HIV/AIDS
      with limited or no insurance.
           More than one-third of all people with HIV in care.


      Nationally: has grown from 183,299 persons in 2007
       to 213,764 in 2010
           Budget: ~$1.4 billion in 2007 - ~$1.8 billion in 2010

 DC ADAP (2007-2010) enrolled about 2,500 clients and provided
  service to about 1,700 clients either by paying for all HIV drugs or
  with insurance help (Co-pay, Premium)

                                           NASTAD. National ADAP Monitoring Report. 2006-2011
ENROLLED CLIENTS VS SERVED CLIENTS
                           2007 to 2011
3,000
                             Total Enrolled      Total Served



2,500




2,000




1,500




1,000




 500




   0




        2007   2008                           2009              2010                 2011



                      AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
National HIV/AIDS Strategy
               (NHAS)
One of the primary goals:
• Increase access to care and optimize health
  outcomes for people living with HIV.
   • “Clinical care providers should ensure
      that all eligible HIV-positive persons have
      access to antiretroviral therapy.”




                    The White House, National HIV/AIDS Strategy for the United States 2010
Objective
 The objective of this analysis was to assess
  how well the Washington DC AIDS Drug
  Assistance Program (ADAP) identified clients
  in need of antiretroviral therapy and the rate
  and rapidity with which they started therapy.
DC DOH & CDC Collaboration

 In 2008, the Senior Deputy Director (Dr. Hader) of the
  HIV/AIDS Administration of the Washington DC Department of
  Health identified ADAP for review to better utilize routine
  information.
 CDC’s rapid analysis of program data determined feasibility of
  linking available databases with the goal to produce routine
  reports to improve performance of the ADAP program.
 2008- 2009: DC DOH had more complete laboratory records
  and transitioned to E-HARS for HIV reporting.
 2009-2010: CDC provided TA to develop a Microsoft
  Application that linked ADAP enrollment data, service
  utilization claims data and health outcome databases and
  generated ADAP program evaluation reports
Methods
Microsoft Access application that merged data
  from three primary sources:
   Service utilization database for client characteristics
       Data from Pharmacy Benefit Management System
        managed by Emdeon
       Enrollment data managed by DC ADAP
   HIV/AIDS Reporting System (HARS) – laboratory
    values for viral load and CD4 cell count.
   Name-based since November 2006
   Electronic HARS in 2009 which facilitated the
    transfer of laboratory values
   Prescription claims data from pharmacy benefit
    management system in the DC ADAP program.
Characterization of Laboratory Values
   CD4 and Viral Load characterized in clinically relevant
    strata.
      CD4 categories (cells/µL):
            0 – 49
            50 – 199
            200 – 349
            350 – 499
            > 500

       Viral load categories (copies/ml):
            < 400
            401 – 999
            1,000 – 9,999
            10,000 – 99,999
            > 100,000
Identified Clients ‘at Risk’

 CD4 count < 350 cells/mm3
 Viral load > 1,000 copies/ml or missing
 Not on antiretroviral therapy in ADAP at time
  of laboratory testing


*US DHHS guidelines consistently recommended to start ART for clients
     with CD4 count <350 cells/mm3 between 2007 – 2010.
*Clients not on antiretroviral therapy in ADAP with viral load <1,000
     copies/ml considered to likely be taking therapy from another source.
Results

 Identify Clients with Indication for
Antiretroviral Therapy and Quantify
       Time to Start Therapy
Washington DC Dept of Health ADAP
       Volume of Laboratory Tests for Analysis

Year                                                 2007              2008             2009        2010


ADAP Eligible Clients (n)                            2022              2403             3212        3359


Viral load test done at least once, n (%)          801 (40)          980 (41)         1298 (40)   2157 (64)


CD4 test done at least once, n (%)                 790 (39)          574 (24)         1212 (38)   2266 (67)




 *Laboratory tests reflect those available in the database.
 Other laboratory tests may have been completed, but not available to this analysis

                              AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
Quantify CD4 Counts among those in
        ADAP – 2007 to 2010
                      n = 394                          n = 799
100%

 90%

 80%

 70%
                                                                                       CD4 cells/mm3
 60%                                                                                       >/=500
                                                                                           350-499
 50%                                                                                       200-349
                                                                                           50-199
 40%
                                                                                           0-49
 30%

 20%

 10%

  0%
         2007      2008      2009      2010         2007      2008      2009      2010
       (n=552)   (n=321)   (n=837)   (n=1719)     (n=315)   (n=286)   (n=451)   (n=1051)


            On ART in ADAP                             Not on ART in ADAP
ART = antiretroviral therapy

                           AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
Identify those not on ART in ADAP and
             ‘at Risk’ - 2010
                          Viral Load Tests done while NOT on ART in ADAP

                                          Viral Load                             Total   At Risk

CD4 count
(cells/mm3)     <= 400 401 - 999 1000 - 9999 10000 - 99999   >= 100000 Missing


0 – 49            4       1          3            7            17        26       58       53


50 – 199          75      2         16           25            12        34      164       87


200 – 349        121      9         11           25            11        27      204       74


350 – 499        133      2         13            30            5        34      217


>= 500           305      9         21            20            2        51      408


Missing           25      2          8            5             5         0       45


Total            663      25        72           112            52       172     1096     214

 ART = antiretroviral therapy

                         AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
Patients in ADAP not on ART & ‘at Risk’
              2007-2010
                                CD4 cell count (cells/mm3)

                                                                         Number of people at
                  0 – 49              50 – 199               200 – 349         Risk


   2007             34                    46                    28              108


   2008             45                    61                    17              123


   2009             42                    73                    44              159

   2010             53                   87                     74             214

   Total           174                   267                   163              604

 A person was considered ‘at risk’ if:
 •VL ≥ 1000 copies/ml
 •CD4+ <350 cells/mm3
 •Not on ART prior to lab test

                         AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
Time from CD4 Count until Initiation of ART
 in ADAP for ‘at Risk’ Patients - 2007-2010
 Year      Eligible to    Started
           start ART
                          ART in               Time from CD4 cell count until Started ART in ADAP (Days)
                          ADAP

                           N (%)        Median        IQR        Range         <30        31 – 60      > 60


 2007         108         67 (62)         8          0-28.5      0-197         52            9             6


 2008         123         47 (38)         14          5-46       0-309         31            7             9


 2009         159         81 (51)         11         1-21.5      0-119         67           10             4


 2010         214        106 (50)         10          0-21       0-167         96            4             6

 Total        604        301 (50)                                             208           30             25


   ART = antiretroviral therapy
   IQR = interquartile range


                          AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
Strata of CD4 cell count who Initiated ART
in ADAP for ‘at Risk’ Patients - 2007-2010
                     CD4 count           Eligible to start   Started ART in ADAP
                     (cells/mm3)               ART                   N (%)
                                                (n)

                        0 – 49                 174                   78 (45)


                       50 – 199                267                   135 (51)


                      200 – 349                163                   88 (54)


                         Total                 604                   301 (50)



  P = 0.12 for comparison of starting ART if CD4 count 0 – 49 vs 50 – 349

  ART = antiretroviral therapy


                         AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
‘At Risk’ Patients not Started on ART in
           ADAP - 2007-2010
   Year      Eligible to    Not Started        Pending2      Time from CD4 cell count until end date
             start ART      on ART in         (<30 days)       of eligibility in calendar year (Days)
                              ADAP1
                                N (%)           N (%)          Median          IQR          Range


   2007         108           35 (32)           6 (6)           102           52-193       32-278


   2008         123           71 (58)           5 (4)           138          80.5-201      30-364


   2009         159           58 (36)          20 (13)          112           68-218       30-360


   2010         214           87 (41)          21 (10)          149          75.5-254      31-357

   Total        604           251 (42)          52 (9)

 1Clients‘not started on antiretroviral therapy in ADAP’ may have received antiretroviral therapy
 from other sources not captured in this analysis.
 2Pending – Clients who had a CD4 cell count in December of the year, but had not started ART

 by December 31 of that year.

 ART = antiretroviral therapy
 IQR = interquartile range

                           AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
Limitations

• Clients ‘not started on antiretroviral therapy
  in ADAP’ may have received antiretroviral
  therapy from other sources not captured in
  this analysis.
• Clients in ‘pending status’ to start ART may
  have started ART in the next year.
• A small percentage of insurance clients who
  receive premium assistance only, not copay
  assistance, is unlikely to use DC ADAP
  network pharmacies and therefore, their
  claims do not exist in the claims data.
Conclusions

• Between 2007 – 2010, many ADAP clients
  eligible for antiretroviral therapy started
  therapy in ADAP documenting the utility of
  this essential public drug assistance program
  (ADAP).
Recommendation

• To improve utilization of antiretroviral therapy
  within ADAP, barriers to starting antiretroviral
  therapy for clients with low CD4 cell counts
  and effective means to overcome them, such
  as outreach services by case management
  services or providers for access and linkage
  to care, should be explored and
  programmatically addressed.
Acknowledgements
Washington DC Department of Health   Centers for Disease Control and Preveniton
Nnemdi Kamanu-Elias                  Paul J Weidle
Sonya Bayone                         David Fluker
Gunther Freehill                     A Danielle Iuliano
Angelique Griffin                    Siva Rangarajan
Damber Kumar Gurung                  Neha Shah
Tiffany Ojo-West
Rowena Samala
Charles Wu
Shannon Hader

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Assessing Linkage to Care by Linking Prescription Filling Records from an AIDS Drug Assistance Program to Laboratory Results from HIV/AIDS Reporting System in Washington DC.

  • 1. Assessing Linkage to Care by Linking Prescription Filling Records from an AIDS Drug Assistance Program to Laboratory Results from HIV/AIDS Reporting System in Washington DC. Gurung DK1, Bayone S1, Freehill G1, Griffin A1, Samala R1, Wu C1, Rangarajan S2,3, Hader S1, Kamanu Elias N1, Weidle PJ3 1HIV/AIDS, Hepatitis, STD & TB Administration (HAHSTA), District of Columbia Department of Health, Government of the District of Columbia, Washington, DC. 2 Satyam Computer Services Limited, Atlanta, GA. 3Division of HIV/AIDS Prevention, CDC, Atlanta, GA. Disclaimer: The findings and conclusions in this presentation are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention or the DC Department of Health.
  • 2. Background  The National AIDS Drug Assistance Program (ADAP) of the Ryan White Comprehensive AIDS Resources Emergency Act.  Source of prescription drugs for people with HIV/AIDS with limited or no insurance.  More than one-third of all people with HIV in care.  Nationally: has grown from 183,299 persons in 2007 to 213,764 in 2010  Budget: ~$1.4 billion in 2007 - ~$1.8 billion in 2010  DC ADAP (2007-2010) enrolled about 2,500 clients and provided service to about 1,700 clients either by paying for all HIV drugs or with insurance help (Co-pay, Premium) NASTAD. National ADAP Monitoring Report. 2006-2011
  • 3. ENROLLED CLIENTS VS SERVED CLIENTS 2007 to 2011 3,000 Total Enrolled Total Served 2,500 2,000 1,500 1,000 500 0 2007 2008 2009 2010 2011 AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
  • 4. National HIV/AIDS Strategy (NHAS) One of the primary goals: • Increase access to care and optimize health outcomes for people living with HIV. • “Clinical care providers should ensure that all eligible HIV-positive persons have access to antiretroviral therapy.” The White House, National HIV/AIDS Strategy for the United States 2010
  • 5. Objective  The objective of this analysis was to assess how well the Washington DC AIDS Drug Assistance Program (ADAP) identified clients in need of antiretroviral therapy and the rate and rapidity with which they started therapy.
  • 6. DC DOH & CDC Collaboration  In 2008, the Senior Deputy Director (Dr. Hader) of the HIV/AIDS Administration of the Washington DC Department of Health identified ADAP for review to better utilize routine information.  CDC’s rapid analysis of program data determined feasibility of linking available databases with the goal to produce routine reports to improve performance of the ADAP program.  2008- 2009: DC DOH had more complete laboratory records and transitioned to E-HARS for HIV reporting.  2009-2010: CDC provided TA to develop a Microsoft Application that linked ADAP enrollment data, service utilization claims data and health outcome databases and generated ADAP program evaluation reports
  • 7. Methods Microsoft Access application that merged data from three primary sources:  Service utilization database for client characteristics  Data from Pharmacy Benefit Management System managed by Emdeon  Enrollment data managed by DC ADAP  HIV/AIDS Reporting System (HARS) – laboratory values for viral load and CD4 cell count.  Name-based since November 2006  Electronic HARS in 2009 which facilitated the transfer of laboratory values  Prescription claims data from pharmacy benefit management system in the DC ADAP program.
  • 8. Characterization of Laboratory Values  CD4 and Viral Load characterized in clinically relevant strata.  CD4 categories (cells/µL):  0 – 49  50 – 199  200 – 349  350 – 499  > 500  Viral load categories (copies/ml):  < 400  401 – 999  1,000 – 9,999  10,000 – 99,999  > 100,000
  • 9. Identified Clients ‘at Risk’  CD4 count < 350 cells/mm3  Viral load > 1,000 copies/ml or missing  Not on antiretroviral therapy in ADAP at time of laboratory testing *US DHHS guidelines consistently recommended to start ART for clients with CD4 count <350 cells/mm3 between 2007 – 2010. *Clients not on antiretroviral therapy in ADAP with viral load <1,000 copies/ml considered to likely be taking therapy from another source.
  • 10. Results Identify Clients with Indication for Antiretroviral Therapy and Quantify Time to Start Therapy
  • 11. Washington DC Dept of Health ADAP Volume of Laboratory Tests for Analysis Year 2007 2008 2009 2010 ADAP Eligible Clients (n) 2022 2403 3212 3359 Viral load test done at least once, n (%) 801 (40) 980 (41) 1298 (40) 2157 (64) CD4 test done at least once, n (%) 790 (39) 574 (24) 1212 (38) 2266 (67) *Laboratory tests reflect those available in the database. Other laboratory tests may have been completed, but not available to this analysis AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
  • 12. Quantify CD4 Counts among those in ADAP – 2007 to 2010 n = 394 n = 799 100% 90% 80% 70% CD4 cells/mm3 60% >/=500 350-499 50% 200-349 50-199 40% 0-49 30% 20% 10% 0% 2007 2008 2009 2010 2007 2008 2009 2010 (n=552) (n=321) (n=837) (n=1719) (n=315) (n=286) (n=451) (n=1051) On ART in ADAP Not on ART in ADAP ART = antiretroviral therapy AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
  • 13. Identify those not on ART in ADAP and ‘at Risk’ - 2010 Viral Load Tests done while NOT on ART in ADAP Viral Load Total At Risk CD4 count (cells/mm3) <= 400 401 - 999 1000 - 9999 10000 - 99999 >= 100000 Missing 0 – 49 4 1 3 7 17 26 58 53 50 – 199 75 2 16 25 12 34 164 87 200 – 349 121 9 11 25 11 27 204 74 350 – 499 133 2 13 30 5 34 217 >= 500 305 9 21 20 2 51 408 Missing 25 2 8 5 5 0 45 Total 663 25 72 112 52 172 1096 214 ART = antiretroviral therapy AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
  • 14. Patients in ADAP not on ART & ‘at Risk’ 2007-2010 CD4 cell count (cells/mm3) Number of people at 0 – 49 50 – 199 200 – 349 Risk 2007 34 46 28 108 2008 45 61 17 123 2009 42 73 44 159 2010 53 87 74 214 Total 174 267 163 604 A person was considered ‘at risk’ if: •VL ≥ 1000 copies/ml •CD4+ <350 cells/mm3 •Not on ART prior to lab test AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
  • 15. Time from CD4 Count until Initiation of ART in ADAP for ‘at Risk’ Patients - 2007-2010 Year Eligible to Started start ART ART in Time from CD4 cell count until Started ART in ADAP (Days) ADAP N (%) Median IQR Range <30 31 – 60 > 60 2007 108 67 (62) 8 0-28.5 0-197 52 9 6 2008 123 47 (38) 14 5-46 0-309 31 7 9 2009 159 81 (51) 11 1-21.5 0-119 67 10 4 2010 214 106 (50) 10 0-21 0-167 96 4 6 Total 604 301 (50) 208 30 25 ART = antiretroviral therapy IQR = interquartile range AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
  • 16. Strata of CD4 cell count who Initiated ART in ADAP for ‘at Risk’ Patients - 2007-2010 CD4 count Eligible to start Started ART in ADAP (cells/mm3) ART N (%) (n) 0 – 49 174 78 (45) 50 – 199 267 135 (51) 200 – 349 163 88 (54) Total 604 301 (50) P = 0.12 for comparison of starting ART if CD4 count 0 – 49 vs 50 – 349 ART = antiretroviral therapy AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
  • 17. ‘At Risk’ Patients not Started on ART in ADAP - 2007-2010 Year Eligible to Not Started Pending2 Time from CD4 cell count until end date start ART on ART in (<30 days) of eligibility in calendar year (Days) ADAP1 N (%) N (%) Median IQR Range 2007 108 35 (32) 6 (6) 102 52-193 32-278 2008 123 71 (58) 5 (4) 138 80.5-201 30-364 2009 159 58 (36) 20 (13) 112 68-218 30-360 2010 214 87 (41) 21 (10) 149 75.5-254 31-357 Total 604 251 (42) 52 (9) 1Clients‘not started on antiretroviral therapy in ADAP’ may have received antiretroviral therapy from other sources not captured in this analysis. 2Pending – Clients who had a CD4 cell count in December of the year, but had not started ART by December 31 of that year. ART = antiretroviral therapy IQR = interquartile range AIDS Drug Assistance Program, Washington DC Dept of Health, 2007 - 2010
  • 18. Limitations • Clients ‘not started on antiretroviral therapy in ADAP’ may have received antiretroviral therapy from other sources not captured in this analysis. • Clients in ‘pending status’ to start ART may have started ART in the next year. • A small percentage of insurance clients who receive premium assistance only, not copay assistance, is unlikely to use DC ADAP network pharmacies and therefore, their claims do not exist in the claims data.
  • 19. Conclusions • Between 2007 – 2010, many ADAP clients eligible for antiretroviral therapy started therapy in ADAP documenting the utility of this essential public drug assistance program (ADAP).
  • 20. Recommendation • To improve utilization of antiretroviral therapy within ADAP, barriers to starting antiretroviral therapy for clients with low CD4 cell counts and effective means to overcome them, such as outreach services by case management services or providers for access and linkage to care, should be explored and programmatically addressed.
  • 21. Acknowledgements Washington DC Department of Health Centers for Disease Control and Preveniton Nnemdi Kamanu-Elias Paul J Weidle Sonya Bayone David Fluker Gunther Freehill A Danielle Iuliano Angelique Griffin Siva Rangarajan Damber Kumar Gurung Neha Shah Tiffany Ojo-West Rowena Samala Charles Wu Shannon Hader