Multi-disease diagnostic integration Optimizing utilization of existing devices in Zimbabwe to expand access to testing for HIV Viral Load

Background – Zimbabwe Country Situation Agenda Background – Zimbabwe Country Situation Integrated testing pilot – proof of concept Comprehensive VL Scale up plan

Background There are about 1.3M people living with HIV (PLHIV) in Zimbabwe HIV services are decentralized, however access to nucleic acid testing (NAT) for early infant diagnosis (EID), and viral load (VL) monitoring, are centralized. In 2017, the estimated VL coverage was 30% At the time, VL testing platform capacity was inadequate to meet programmatic VL demand There was a lack of systems to quickly deliver VL results back to health facilities within one week In 2016, Zimbabwe had 130 GeneXpert (Xpert) procured under the TB program, with an estimated overall device utilization of 27%, used only for TB testing Xpert EID and VL were approved for clinical use by the end of 2016 Note: The 2,880 is based on 16 TB tests per day (240 working days/year and 6 hours operation per day); MOHCC determined there was a need to increase coverage and quality of VL in the context of excess capacity on existing Xpert devices

Background – Zimbabwe Country Situation Agenda Background – Zimbabwe Country Situation Integrated testing pilot – proof of concept Comprehensive VL Scale up plan

MOHCC conducted an integration pilot to determine feasibility TB and HIV programs agreed to pilot integrated EID, targeted VL and TB testing on existing GeneXpert devices Duration 5 months (Oct ‘17 – Feb ‘18) Number of Health Facilities 8 urban health facilities: 4 EID/VL/TB & 4 VL/TB only (already had POC EID) Selection of facilities where projected TB demand, EID demand and VL demand could be accommodated Baseline EID/VL DBS to Central lab Pilot EID/VL Xpert placed in lab, operated by lab staff VL prioritization Pregnant and breastfeeding women Children and Adolescent Suspected failures

* Zimbabwe annual throughput GXIV: 2880 Adding HIV testing to existing GeneXpert devices demonstrated increased device utilization without exceeding machine capacity Device Utilization Across EID/TB/VL Target optimal utilization 75% Key = VL = EID = TB * Zimbabwe annual throughput GXIV: 2880 EID and targeted VL testing volumes can be accommodated on existing GeneXpert devices that are in operation in laboratories

Onsite VL was effectively targeted, improved quality of care for viremic clients, without compromising TB testing and clinical care On-site VL enabled faster EID and VL testing A greater proportion of patients with elevated VL received their results: 48% at baseline and 96% during the pilot A greater proportion of patients with elevated VL had a documented a clinical action (either EAC or 2L switch): 48% improved to 83% Timeliness of TB testing and treatment initiation for Mtb+ patients did not change with the additional HIV testing: Median 2 days (IQR:1-3) from sample collection to patient receipt of result both pre/post 47% treatment initiation in baseline and 48% during pilot Overall device utilization increased which may enable cost-efficiencies With appropriate planning, integrated HIV-TB testing was feasible, demonstrating synergies across the two programs

Background – Zimbabwe Country Situation Agenda Background – Zimbabwe Country Situation Integrated testing pilot – proof of concept Comprehensive VL Scale up plan

Zimbabwe has recently launched The Viral Load Scale Up Plan Road Map to guide VL testing scale-up in Zimbabwe from 30% (end of 2017) to >95% by the end of 2020 as follows: 2018 60% of those PLHIV on ART 2019 80% of those PLHIV on ART  2020 95% of those PLHIV on ART  Establish collaboration and coordination between government and partners as they provide VL testing services in the country Utilize Diagnostics Network Optimization for efficient integration of testing Provide clear direction on procurement and supply chain strategies for VL testing services to allow for improved and sustainable access GOAL: Expand clinical and laboratory capacity to conduct at least 1 million VL tests annually for routine VL monitoring for all PLHIV on ART by the end of 2019. Source: Zimbabwe Viral Load Scale up plan 2018-2020

There are 22 conventional instruments currently available and operational across the country with a capacity of 934,000 test per year currently Source: Zimbabwe Viral Load Scale up plan 2018-2020

GeneXpert platforms in the country provide an opportunity to expand access to VL Testing particularly for relevant key population VL Testing capacity plan POC VL could be particularly relevant in specific populations to reduce onward HIV transmission Population Reason Pregnant Women To ensure viral suppression to minimize MTCT and/or identify infants at high risk of infection who should be prioritized for enhanced ARV prophylaxis at birth. Lactating Mothers To ensure viral suppression to minimize MTCT Individuals in sero-discordant couples Ensuring viral suppression is important to reduce onward HIV transmission risk Children, adolescents, failure suspects, patients with advanced disease At higher risk of having elevated VL and would benefit from prompt EAC services or regimen switch Source: Zimbabwe Viral Load Scale up plan 2018-2020

Opportunities in Zimbabwe: VL testing landscape Through diagnostics network analysis utilizing existing 22 centralized NAT systems to design rational sample referral systems Currently of the 130 existing near POC GeneXpert devices, 41 are multiplexing TB, HIV and EID Consensus built between TB/HIV programs through the initial pilot The country has 57 mPima platforms: plans are already underway to evaluate the mPima for VL for multiplexing (already in use for EID) Through a blend of centralized, near POC and POC, Zimbabwe expects to reach its VL testing targets, leveraging integration

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