UNITAID/EGPAF Project to Optimize Early Infant HIV Diagnosis through the Introduction of Point of Care Testing Optimization of EID networks through introduction of POC EID to increase the number of infants tested and initiated on ART: Creating a market for affordable, effective and equitable HIV testing of exposed infants

Gaps in Current Early Infant Diagnosis Cascade 51% 50% 8.9% 51% Challenge 1: Poor access to and delays in EID testing 51% of 1.2 million HIV-exposed African children had access to EID testing in 2014 Most HIV-exposed infants receive their first test at age 6 months or later (WHO recommends first test at 6 weeks) Challenge 2: Delays or no return of test results Median time of 30 to 90 days from sample to delivery of results Only 50% of children who are tested receive their test results Challenge 3: Poor initiation of HIV-positive infants on treatment SA study: 10 week delay between diagnosis and initiation of treatment Kenya study: 44% of HIV- positive infants never reached ART clinic Challenge 1: Poor access to and delays in EID testing 51% of 1.2 million HIV-exposed African children had access to EID testing in 2014 Most HIV-exposed infants receive their first test at age 6 months or later (WHO recommends first test at 6 weeks) Challenge 2: Delays or no return of test results Median time of 30 to 90 days from sample to delivery of results Only 50% of children who are tested receive their test results Challenge 3: Poor initiation of HIV-positive infants on treatment SA study: 10 week delay between diagnosis and initiation of treatment Kenya study: 44% of HIV- positive infants never reached ART clinic Source: On the Fast-Track to an AIDS-Free Generation, UNAIDS, 2016

Goal, Purpose, and Scale of the 4-Year Project Goal: to increase the number of HIV- positive infants whose HIV status is known and facilitate early ART initiation. Purpose: ensure that at-risk infants have timely access to HIV testing through scale-up of POC EID in the context of optimizing existing national EID networks Scale: 9 countries 4 years $63 million Estimated 297 POC EID platforms and up to 320,000 tests Goal: to increase the number of HIV- positive infants whose HIV status is known and facilitate early ART initiation. Purpose: ensure that at-risk infants have timely access to HIV testing through scale-up of POC EID in the context of optimizing existing national EID networks Scale: 9 countries 4 years $63 million Estimated 297 POC EID platforms and up to 320,000 tests

Five Project Outputs/Objectives 1.Put in place conditions necessary to introduce and scale up POC EID in each country 2.Procure POC EID platforms and tests 3.Place and scale-up POC EID according to the national EID network plan 4.Generate and share data and evidence on the impact of POC EID on pediatric HIV treatment cascade 5.Support the development, adoption and initial implementation of transition plans in each country

Output 1: Necessary Conditions in Place Key activities: Work with MOH TWG to map the EID network and develop national EID optimization plans Negotiate volume-based/pooled demand agreements with manufacturers for global procurement of platforms and test Ensure that POC EID is registered in the country Support controlled and closely- monitored introduction of suitable POC EID platforms, taking into consideration service delivery needs and product registration status EID network plans will identify the optimal combination of conventional EID, POC EID, and/or POC EID Hubs to increase access, decrease time for return of results, and allow for an expanded testing algorithm. Conventional EID POC EID Hub POC EID

Output 2: Procure POC EID Platforms and Tests Key activities: Phased, market-shaping procurement and closely-monitored use of platforms and tests in line with the joint procurement strategy with CHAI/UNICEF Deliver platforms and tests to each country Integrate POC EID products into current supply chain systems Develop and implement post-market surveillance, QA, and connectivity plans Review procurement strategy on an annual basis Phased Procurement and Roll-Out of POC EID Platforms Total Plat- forms Year 1 Pilots Year 2 Pilot + Scale up Year 3 Year 4 (Transi -tion) Cameroon Cote d'Ivoire Kenya Lesotho Mozambique Rwanda Swaziland Zambia Zimbabwe Total Platforms Procurement Estimates on 1 June 2016

Three POC EID products available in market with several others in the development pipeline /2017 Alere q Alere GeneXpert Cepheid LYNX HIV p24 Antigen NWGHF Micronics SAMBA EID DDU/Cambridge GeneXpert Omni Cepheid Results of CDC Evaluations

Product Selection Approach 1.Ensure product is “fit for purpose” for selected sites – Demand: supports national EID network plan; ease of installation and use; registered – Supply: Multi-functional platforms, production capacity; distribution capacity; ability to meet timelines; unit cost; warranty; freight and insurance; service and maintenance, availability of consumables; quality assurance (e.g. CE, WHO-PQ) 2.Country choice principle/responsive to country needs – Final decision rests with MOH, using validated decision tools, based on national EID network plan and, where relevant, results of evaluations and pilots 3.Pilot sites – Phased procurement and roll out: Platforms placed in selected sites in Year 1 to assess factors such as suitability, infrastructure support, number of tests performed, platform performance, health worker ability to use it 4.Routine use – Based on pilot phase results, revise the National EID Network Plan and scale up introduction in more settings

Quality Assurance Only products that are in compliance with UNITAID Quality Assurance Policy are eligible for procurement.

POC EID pricing Alere QCepheid GeneXpertSAMBA II Platform: $USD 25,000, includes battery, modem and printer (includes 1 yr warranty) GeneXpert-IV platform: $USD 17,500 incl. laptop, (includes 2-yr warranty) Platform: Assay Module= $26,750 including tablet, security system, printer & paper (includes 1-yr warranty) Cartridge: $25.00Cartridge: $USD 17.95Cartridges; $ % distribution margin NACost of gel battery (required): $2,500-4,000 Cost of battery and charger- inverter: TBD Extended warranty: $2,500/yearExtended warranty: $2,900 for each additional year, or $6,850 for 3 additional years if purchased with instrument, or $7,900 for 3-additional years if purchased after instrument purchase Extended warranty: 2-yr extended warranty for $3,250/ry or $6,500 for 2 yrs

Output 3: Introduce POC and Near POC Networks to Optimize EID Community- based Testing “Roving” POC Mobile Clinics Sample Transport POC EID Platforms

Output 3: Select Appropriate Entry Points for Point-of-Care EID testing 22.5%14.2% 2% 5% 3.3% Results of HIV testing among children under five in different service settings Source: Cohn J et al. Systematic literature review presented to the WHO guidelines committee, June 2015 (and submitted for publication).

Strategic placement within a single health facility to serve: Sick child clinic Maternity wards (testing at birth) Immunization clinics Pediatric TB clinics Nutrition ward Etc. Placement scenarios: One point-of-care device can serve multiple entry points within a single facility

Potential Scenarios: Achieving Key EID Objectives within Different Health System Contexts Regional Facilities District Facilities Clinics and Health Posts Scenario 1: Increase Access in Under-served Areas National Lab Low Through-Put POC EID High- Throughput POC EID Tertiary Facilities Regional Facilities District Facilities Clinics and Health Posts Scenario 2: Decrease Turn-Around Time In High-Volume Facilities High- Throughput POC EID or near POC EID Tertiary Facilities National Lab Regional Facilities District Facilities National Lab Mobile Comm- unity Health Posts Scenario 3: Maximize Access & Volume in Decentralized Areas With High-Throughput POC EID Hubs Tertiary Facilities

Medium Clinics District Hospital Regional/Provincial Hospitals Tertiary Hospitals Small Clinics Health Posts, Outreach, Mobile Clinics Test Volume Per Day < >16 Placement Scenarios: Volume of Tests and Levels of Health Facilities Possible Diagnostics Mix Conventional high throughput Mix of conventional and point-of-care Point-of-care Point-of-care hub for a network of clinics Portable point-of- care (not yet available)

Placement Must Ensure Strong Links to Care and Treatment: Availability of a Test is Not Sufficient Source: Beard S, CDC, Center for Global Health (2015)

Output 3: Implement the full national algorithm (pilot point-of-care testing at birth) New Kenya Testing Algorithm 6 months 18 months 6 weeks Birth Critical Mortality Period 6 weeks 9 months 18 months Old WHO/Kenya Testing Algorithm 12 months

Output 3: Maximize Platform Capacity to Increase Access to Viral Load Monitoring Joint EID and VL utilization may contribute to higher demand and improved maintenance, staffing, prioritization of platforms Creates and opportunity to significantly increase access to VL over next 4 years Challenge: Ensure priority for EID testing

Output 4: Generate and Share Evidence Key activities: Conduct studies to evaluate the impact of POC EID on EID testing coverage, turn-around time of test results, number and percentage of infants/caregiver receiving results, number of days from HIV diagnosis to ART initiation Perform a comprehensive comparative cost analysis of POC EID versus conventional EID (cost/test; cost/infection detected; cost/infant on ART) Agree on and apply mechanisms for the transparent sharing of data and evidence

Output 5: Transition the Project Key activities: Develop, adopt and implement transition plans for each country – Transition planning begins from the start of the project to ensure involvement and collaboration of Global Fund, PEPFAR, CIFF, UNITAID and other donors, and to build national capacity to ensure continuity of the project beyond UNITAID funding. – Goal is to ensure that financial resources are available to continue the program at the sites where it was initiated.

Intended Impact of the UNITAID Project

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