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Pilot Implementation of Point-Of-Care, CD4 Counting in Mozambique’s National Health System


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Presentation at the IAS 2011 conference on 18 July 2011 by Ilesh V. Jani, Instituto Nacional de Saúde, Mozambique.

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Pilot Implementation of Point-Of-Care, CD4 Counting in Mozambique’s National Health System

  1. 1. Pilot Implementation of Point-Of-Care CD4 Counting in Mozambique’s National Health System<br />Ilesh V. Jani<br />Instituto Nacional de Saúde<br />Maputo, Mozambique<br />
  2. 2. Acknowledgements<br /><ul><li>MISAU
  3. 3. INS
  4. 4. CHAI
  5. 5. Provincial Health Authorities in Maputo City, Maputo Province, Gaza, Sofala and Niassa
  6. 6. Implementing Health Centres
  7. 7. Anglican Church, Niassa Province
  8. 8. MSF-Belgium
  9. 9. MSF-Switzerland
  10. 10. ARK
  11. 11. UNITAID</li></li></ul><li>The Use of Rapid Tests Allowed Dramatic Scale Up of HIV Counselling and Testing<br />Source: Ministério da Saúde, Moçambique<br />
  12. 12. HIV Rapid Testing – Leaps and Hiccups?Proficiency Testing Programs Show That Error Rates Are High in Some Settings<br />% of Participating Institutions<br />Number of Participations in the EQA<br />Source: Instituto Nacional de Saúde, Moçambique<br />
  13. 13. Mozambique’s National Health System Adopted a Multi-Step Evaluation Process for Point-Of-Care Technologies<br />Technology Selection<br />Technical Evaluation<br />(Laboratory, Field)<br />Pilot Implementation<br />(Site, Province)<br />
  14. 14. How to Select Technologies to Evaluate?<br /><ul><li>Description of technology and parameters
  15. 15. Type of technology (disposable, handheld, tabletop)
  16. 16. Technical Sophistication
  17. 17. Mobility & Size
  18. 18. Routine Maintenance Requirements
  19. 19. Instrument Throughput
  20. 20. Power Source
  21. 21. Alternate Power Source Availability
  22. 22. Capital Cost of Equipment</li></ul>30 criteria across 4 categories<br />Technology<br />Attributes<br />30%<br /><ul><li>Heat and Humidity
  23. 23. Type of Sample Tubes
  24. 24. Need for Centrifuge
  25. 25. Reagent & Control Preparation
  26. 26. Expiration Period
  27. 27. Reagent and Consumable Cost</li></ul>Testing Method & Procedures<br />40%<br />Reagents, <br />Consumables &<br />Supplies<br />20%<br /><ul><li>Internal Quality Control
  28. 28. External Quality Control
  29. 29. Daily Calibration Requirements
  30. 30. Number of Steps in Procedure
  31. 31. Type of Sample Required
  32. 32. Precise Sample Measurement Requirements
  33. 33. Batching
  34. 34. Result Delivery
  35. 35. Result Storage
  36. 36. Instrument Connectivity
  37. 37. Waste Generation</li></ul>Other Company Information<br />10%<br /><ul><li>Service and Maintenance
  38. 38. Supply Chain and Distribution
  39. 39. Timing & Regulatory Status
  40. 40. Installation</li></li></ul><li>Primary Health Care Nurses Can Accurately Perform CD4 Counts and Toxicity Monitoring Using Point-Of-Care Devices<br />Alere PIMA (Lab Techs) vs. BD FACSCalibur<br />Alere PIMA (Nurses) vs. BD FACSCalibur<br />Limits of Agreement -249 to +148<br />Limits of Agreement -314 to +257<br />But training on capillary blood collection is critical!<br />Jani et al. AIDS (2011) <br />
  41. 41. Pilot Implementation Was Initially Done in Six Clinics and One Mobile Team<br /><ul><li>Six primary health care clinics in urban and rural settings
  42. 42. One mobile team in a remote rural area in the north of Mozambique
  43. 43. Chart review for data collection performed at baseline and post-implementation</li></li></ul><li>Point-Of-Care CD4 Counting Reduces Pre-Treatment Loss-To-Follow-Up<br />Percent Of Patients Receiving <br />CD4 Test Results<br />Percent Of Patients Returning<br />After Initial CD4<br />
  44. 44. A Mobile Team Successfully Operates in Northern Lake Niassa, Mozambique<br />Setting: population ~20,000, area 1,600 km2.<br />Strategy: Every 2 months, 2 community health workers, with no formal health qualifications, make a round trip of 220 km on foot or kayak, stopping at 8 health posts.<br />Cumberland et al. Poster TULBPE060; IAS 2011<br />
  45. 45. Sites with POC CD4 Perform Well in the National Proficiency Testing Program<br />Sites with <br />POC CD4<br />Sample QC49, <br />average absolute CD4 count=400 cells/mm3<br />Source: Instituto Nacional de Saúde, Moçambique<br />
  46. 46. A Pilot Implementation in Currently Ongoing in Mozambique’s Gaza Province<br />Main Objectives:<br />- Test an approach for the implementation of point-of-care CD4 counting from a health system perspective.<br />- Develop and validate tools to assist provincial authorities in scaling-up the implementation of point-of-care assays.<br />
  47. 47. Site Matrix<br />Preliminary site list generated from a site <br />selection matrix.<br />Nov <br />2010<br />Provincial Coordination<br />Provincial stakeholder meetings. Site list validated.<br />POC ToT<br />Central level team trains provincial trainers.<br />Dec <br />2010<br />Provincial trainers train and certify local POC <br />CD4 operators.<br />Train Sites<br />Site Introduction<br />Sites mentored. New patient flow diagrams <br />implemented. Sites begin to implement POC CD4.<br />Jan <br />2011<br />Joint Stakeholder evaluation meetings. Discussion <br />of lessons learnt. Road map for continuous <br />improvement. Validation of tools. <br />Periodic Evaluation<br />May <br />2011<br />
  48. 48. Expected Outputs of the<br />Provincial Pilot:<br /><ul><li>Site selection tool
  49. 49. Implementation process manual
  50. 50. Laboratory
  51. 51. Clinic
  52. 52. Logistics and supply chain
  53. 53. Quality assurance
  54. 54. Training curriculum
  55. 55. Recommendations for division of responsibilities (national, provincial, local)</li></li></ul><li> The Improvement of Access to CD4 Counting is Not Uniform Across All Clinics<br />NEW TECHNOLOGY IS NOT <br />THE SOLE SOLUTION<br />Limiting Factors:<br /><ul><li> Limited human resources - Change of culture
  56. 56. Patient overflow - Patient education
  57. 57. Clinic workflow</li></li></ul><li>Ultimately, sucessful implementation of point-of-care diagnostics will be about changing health systems, creating a new health care culture and shifting responsibilities to primary health care level.<br />In the coming years we will need to learn fast through implementation research.<br />OBRIGADO!<br />