1. Pilot Implementation of Point-Of-Care CD4 Counting in Mozambique’s National Health System Ilesh V. Jani Instituto Nacional de Saúde Maputo, Mozambique

2. Acknowledgements MISAU INS CHAI Provincial Health Authorities in Maputo City, Maputo Province, Gaza, Sofala and Niassa Implementing Health Centres Anglican Church, Niassa Province MSF-Belgium MSF-Switzerland ARK UNITAID

3. The Use of Rapid Tests Allowed Dramatic Scale Up of HIV Counselling and Testing Source: Ministério da Saúde, Moçambique

4. HIV Rapid Testing – Leaps and Hiccups? Proficiency Testing Programs Show That Error Rates Are High in Some Settings % of Participating Institutions Number of Participations in the EQA Source: Instituto Nacional de Saúde, Moçambique

5. Mozambique’s National Health System Adopted a Multi-Step Evaluation Process for Point-Of-Care Technologies Technology Selection Technical Evaluation (Laboratory, Field) Pilot Implementation (Site, Province)

6. Other Company Information 10% Testing Method & Procedures 40% Reagents, Consumables & Supplies 20% Technology Attributes 30% Heat and Humidity Type of Sample Tubes Need for Centrifuge Reagent & Control Preparation Expiration Period Reagent and Consumable Cost Internal Quality Control External Quality Control Daily Calibration Requirements Number of Steps in Procedure Type of Sample Required Precise Sample Measurement Requirements Batching Result Delivery Result Storage Instrument Connectivity Waste Generation Service and Maintenance Supply Chain and Distribution Timing & Regulatory Status Installation Description of technology and parameters Type of technology (disposable, handheld, tabletop) Technical Sophistication Mobility & Size Routine Maintenance Requirements Instrument Throughput Power Source Alternate Power Source Availability Capital Cost of Equipment 30 criteria across 4 categories How to Select Technologies to Evaluate?

7. Primary Health Care Nurses Can Accurately Perform CD4 Counts and Toxicity Monitoring Using Point-Of-Care Devices Alere PIMA (Lab Techs) vs. BD FACSCaliburAlere PIMA (Nurses) vs. BD FACSCalibur Limits of Agreement -314 to +257 Limits of Agreement -249 to +148 But training on capillary blood collection is critical! Jani et al. AIDS (2011)

8. Pilot Implementation Was Initially Done in Six Clinics and One Mobile Team Six primary health care clinics in urban and rural settings One mobile team in a remote rural area in the north of Mozambique Chart review for data collection performed at baseline and post- implementation

9. Point-Of-Care CD4 Counting Reduces Pre-Treatment Loss-To-Follow-Up Percent Of Patients Receiving CD4 Test Results Percent Of Patients Returning After Initial CD4

10. A Mobile Team Successfully Operates in Northern Lake Niassa, Mozambique Setting: population ~20,000, area 1,600 km 2. 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. Cumberland et al. Poster TULBPE060; IAS 2011

11. Sites with POC CD4 Perform Well in the National Proficiency Testing Program Sites with POC CD4 Sample QC49, average absolute CD4 count=400 cells/mm 3 Source: Instituto Nacional de Saúde, Moçambique

12. A Pilot Implementation in Currently Ongoing in Mozambique’s Gaza Province Main Objectives: - Test an approach for the implementation of point-of-care CD4 counting from a health system perspective. - Develop and validate tools to assist provincial authorities in scaling-up the implementation of point-of-care assays.

13. Provincial Coordination Site Matrix POC ToT Train Sites Site Introduction Periodic Evaluation Nov 2010 Dec 2010 Jan 2011 May 2011 Preliminary site list generated from a site selection matrix. Provincial stakeholder meetings. Site list validated. Central level team trains provincial trainers. Provincial trainers train and certify local POC CD4 operators. Sites mentored. New patient flow diagrams implemented. Sites begin to implement POC CD4. Joint Stakeholder evaluation meetings. Discussion of lessons learnt. Road map for continuous improvement. Validation of tools.

14. Expected Outputs of the Provincial Pilot: Site selection tool Implementation process manual –Laboratory –Clinic –Logistics and supply chain –Quality assurance Training curriculum Recommendations for division of responsibilities (national, provincial, local)

15. The Improvement of Access to CD4 Counting is Not Uniform Across All Clinics NEW TECHNOLOGY IS NOT THE SOLE SOLUTION Limiting Factors: - Limited human resources- Change of culture - Patient overflow- Patient education - Clinic workflow

16. OBRIGADO! 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. In the coming years we will need to learn fast through implementation research.