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

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

3. 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

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

5. 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

6. * 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

7. 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

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

9. 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:
% of those PLHIV on ART
% of those PLHIV on ART 
% 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

10. 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

11. 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

12. 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

13. Questions?