Ministry of Health, Kenya National roadmap on utilization of multi-disease Point-of-Care testing for HIV,TB and HPV in Kenya Dorcus Abuya

EID AND VIRAL LOAD TESTING IN KENYA; Situational Analysis SOC Opportunities for POC The map on the left shows the 8 viral load and EID testing labs in Kenya, shown by the red circles. The regions colored on the Kenyan map are networked around these 8 labs. For example- the region highlighted light blue- take their samples to the KEMRI-lab in Nairobi. With the Standard of Care (SOC) system illustrated here, and as far as the UNAIDS 90-90-90 targets is concerned, Kenya has attained only 74% of the 1st 90 UNAIDS target (diagnosis). Meaning there is a gap of about 26% to enable Kenya attain the desired 90%. 80% of the target has been attained for ART coverage wit 70% viral load suppression at community level. While the routine viral load uptake has tremendously improved with the current SOC in place, there still remain missed opportunities in meeting the 3rd 90 targets Additionally, with the change of EID guidelines that now requires two additional PCR test at 6 and 12 months, coupled with the introduction of birth testing by PCR, it is expected that the number of EID tests will escalate to over 250000 tests. It is therefore evident that the SOC doesn’t meet the country’s demand for HIV testing and introduction of POC is therefore expected to complement the SOC. Over 250000 EID tests annually

POC multi-disease implementation document The NPHLS through partner and stakeholder involvement developed the utilization of multi-disease testing platforms for optimizing EID in Kenya guidelines. PLHIV The process has taken into consideration PLHIV or at risk of HIV (HEI) as the central beneficiaries of POC.

Key pillars anchoring the POC implementation documents Strategic information Leadership and Governance 1 3 4 POC business plan Quality Management system 7 2 Regulatory approvals 6 Advocacy 5 Product and site selection & Integrated specimen and referral system Capacity Building

Leadership & Governance 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. Transformational leadership Coordinated and responsive partnerships Evidence-informed implementation strategies Regulatory approvals Support Device Evaluation Registration of the POC device Post Market Surveillance

NASCOP/NTLP/NPHL/DRH County POCT Mentors County TOTs NASCOP/NTLP/NPHL/DRH National POCT TWG National POCT Coordinator COUNTY Health Management Organs County POCT TWG County POCT Coordinator Manufacturer Application Trainers Master Trainers Facility Health Management Organs Facility POCT Committee POCT Supervisor POCT SDPP

Product and site selection Strategies integrated mapping of facilities and site selection across all disease programsMapping Identify appropriate products for deployment for POCT Sample prioritization Documented criteria set up by all disease programs will be considered for deployment of POCT devices across the sites Integrated Sample referral networking A robust TB/HIV point of care (POC) specimen referral network laboratory handbook that serve as a guide to all HCW Regular meetings by the county TWGs to review re-networking Product and site selection Capacity building Implement training material for Super and End-User training Establish and integrate support supervision of POCT Recertification of end users

Quality Management System Strategic information 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 PT plan for all the test analytes supported by POCService contracts of the POC devices Lot to lot performance during PT assessment Regular on-site supervision for corrective action Quality indicator monitoring 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

ROADMAP TO IMPLEMENTATION OF MULTI-DISEASE POC TECHNOLOGIES 2014 2015 Development of POC policies and guidelines National launch of POC policies and guidelines 2016 Success story Development of POC implementation plan and utilization of multi- disease testing plan 2017 2017 Scale up of POCT at identified facilities National launch of POC business plan and multi-disease testing plan Dec-2018 Piloting of the POC in selected facilities

CONCLUSION The newly developed utilization of multi-disease platforms to optimize EID testing in Kenya document is a promising government initiative by providing universal access to PLHIV but in addition, improving health systems to support the service provision, provide significant system efficiencies and cost savings and increase patient access at county level. .

DISCLAIMER ACKNOWLEDGEMENTS No conflict of interest by all contributing authors ACKNOWLEDGEMENTS Ministry of Health National Public Health Laboratories National AIDS and STI Control Program CDC EGPAF Kenya Medical Lab Technicians and Technologists Board UNICEF CHAI

National Public Health Laboratory Services Ministry of Health National Public Health Laboratory Services Thank You