Key Considerations in Implementing HIV Point-of-Care testing in Kenya

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1 Ministry of Health, Kenya 1. National Public Health Laboratories 2. National AIDS & STI Control Program Key Considerations in Implementing HIV Point-of-Care testing in Kenya Nancy Bowen 1 Dr. Rose Wafula 2 Dorcus Abuya 1 Mamo Umuro 1

2 EID AND VIRAL LOAD TESTING IN KENYA; Situational Analysis SOC CASCADE Reached Unreached A LHIV KENYA D IAGNOSED A RT V IRAL SUPPRESSION % % % Opportunities for POC By October 2016; UNAIDS report Over EID tests annually

3 POLICIES AND GUIDELINES Several policy documents that acknowledge and recommend the use of POCT in HIV diagnostics

4 First things first; Development of National POC Implementation plan n While Kenya has a robust HIV lab network POCT has been identified to address her unmet needs of HIV EID and Viral load testing. Health care providers The NPHLS through partner and stakeholder involvement developed the Key Considerations in Implementing Point of Care in Kenya guidelines. national and county health policy makers laboratory service providers [CATEGORY NAME] Users PLHIV program managers development partners implementing partners investors

5 Key pillars anchoring the POC business plan c Quality Management system Advocacy Strategic information 1 POC business plan Leadership and Governance 2 Regulatory approvals Service Delivery Capacity Building

6 Strategies Leadership & Governance Ensure national inclusion of POC in national plans, policies and guidelines Establish national and county committees for inclusion of POC in national response. Adapt and Operationalize SOPS Regulatory approvals Support Device Evaluation Registration of the POC device Post Market Surveillance

7 Strategies Service Delivery Identify appropriate products for deployment for POCT Develop service agreement to support reagent rental for POCT Harmonize Procurement and Distribution of POCT Establish sample and result delivery referral network Establish a Roving mechanism of POC devices to improve access to testing Capacity building Implement training material for Super and End-User training Establish and integrate support supervision of POCT

8 Strategies Advocacy Demand creation to ensure leadership buy in at the County level and engaging communities of PLHIV Sensitization of community health workers and CSO networks communities on POC vis a vis test and treat Sustaining the POC foothold Quality Management System Establish a QA scheme for POC Service contracts of the POC devices Accreditation of POC Strategic information Enhance system capacity to meet lab and program data demand, and transmit quality data. High quality strategic information used for public health action

9 Barriers to implementation of POCs Verification verses full technical validation Registration process Costs, TAT, Post market surveillance Frequent policy guideline changes Devolution and Different Implementation structures Parallel programming POC Partner coordination Logistics flow Specimen referral logistics Bottleneck on dissemination of POC policies and guidelines Lack of technical support from in country vendors/companies Unclear technical support mechanism High turn over increasing investment needs for capacity building Lack of established EQA program for POC Poor connectivity which limits application of data to inform policy and guidelines

10 ROADMAP TO IMPLEMENTATION OF POC TECHNOLOGIES 2014 Development of POC policies and guidelines 2016 Development of POC implementation plan 2015 National launch of POC policies and guidelines 2017 National launch of POC business plan Success story Implementing POCT at identified facilities Dec- 2017

11 CONCLUSION The newly developed national Point of Care implementation plan is a promising government initiative will better treatment outcomes to PLWHAs with the overall goal in using innovative technology to attain the KASF targets.

12 ACKNOWLEDGEMENTS Ministry of Health (NPHLS,NASCOP,KMLTTB,NHRL) EGPAF UNICEF CHAI CDC USAID MSF Disclosure The author of this presentation is a representative of the MoH, Kenya. Terms and conditions have been reviewed. This plan was funded by the MoH Kenya with support from partners