1. Integrated Testing on the GeneXpert
Optimizing utilization of existing GeneXpert devices in Zimbabwe to expand access to testing for EID, TB/MDR-TB and HIV Viral Load

2. The aim of the integration pilot is to determine the feasibility of providing high quality and timely EID, TB, and VL testing on the existing Xpert® devices
Goal
To demonstrate how spare capacity across existing Xpert® devices could be utilized by both HIV and TB programs to ensure improved access to TB testing, EID and HIV VL testing at health facilities and optimize workflow and device usage.
Expected Outcomes
Patient Impact Assessment
Feasibility Assessment
Acceptability Assessment
Objectives
Determine the feasibility of providing high quality and timely EID, TB and VL testing on existing Xpert® devices that are currently only being used for TB diagnosis at 10 health care facilities in Zimbabwe over 6 months.
Determine the optimal flow of patients, samples and results for integrated testing at health facilities included in the pilot..
Phase 1
Phase 2
Determine the acceptability of integrated testing on the 4X-Xpert® by clinicians and lab personnel in the 10 public health facilities.
Assess the patient impact of integrated testing on existing Xpert® platforms at the 10 health facilities over a period of 6months.

3. Site Selection Process1
Selection of 10 pilot sites by using existing available information from the programs
Existing sites (TB GX, EID, ART)
Patient volume
Access to regional labs
TB/HIV prevalence
ART coverage
Spare capacity
Primary Criteria:
Sites with:
High/moderate volume of TB suspects (>200 in 2015)
High volume of ART patients (>1500 patients on ART)
Sites with:
Existing access to conventional VL and EID testing at regional molecular labs
Long TAT (>4 weeks) for EID and VL
2015 Xpert® utilization rate < 35% 2
Assessment of sites to determine spare capacity
Xpert ®Testing Capacity
HIV Testing Need at the Facility
Annual TB testing volume
# Adults on ART (proxy for adult VL testing need)
Annual TB testing need
# Children on ART (proxy for children VL testing need)
Spare annual testing capacity which could be used for HIV testing
# Exposed infants (proxy for EID testing need)
Operating hours per day or days per month and device
downtime per month
Annual EID testing volume and VL testing volume
Data collected: 3
Other factors considered for site selection:
Willingness of facility to support implementation pilot and take ownership beyond pilot
Sites assessment outcome to confirm pilot sites

4. Preliminary pilot data provides evidence supporting feasibility of integrated testing on the GX1
TB testing patterns maintained:
TB samples were prioritized for testing over viral load specimens.
EID specimens prioritized over TB specimens due to the need to quickly initiate babies on ART and due the low volume of EID specimens, this prioritization schedule did not cause any significant disruptions to TB testing patterns 2
Device maximum utilization not fully reached:
Average utilization rate for the pilot sites was 12.7% prior to the pilot and this has increased to 31.1%.
With the change in the TB testing algorithm beginning this year, around 25% potential output can still be leveraged for HIV related tests while maintaining TB testing patterns. 3
Work flow models:
The flow of patients, samples and results is left to the discretion of the facility.
Nurses are responsible for deciding which patients were eligible for testing on the Xpert®.
The lab prioritizes the testing prioritizations.

5. EID TB VL Patient Population
Onsite EID testing for all infants between 6 weeks and 18months’ old requiring a test. TB
From September to December 2016, TB testing for HIV co-infected patients and DR-TB suspects.
Starting January 2017, due to change in national TB algorithm, sputum samples collected from all TB suspects for initial TB diagnosis VL
Onsite viral load testing initially targeted for pregnant and lactating mothers, children, treatment failure suspects and patients highly susceptible to LTFU (due to long traveling distances, financial constraints and other factors as determined by clinicians)

6. Integration Preliminary findings
Increase in utilization from 12.7% in 2015 to 31.1% during the pilot
Beginning 2017, national TB testing algorithm changed to recommend Xpert testing for all TB suspects for
initial diagnosis indications are that this will increase utilization to 65% for TB tests only , leaving 25% remaining
spare capacity for EID and VL tests.
Opportunity for placement of 16 module GX at high volume
Action Plan: In phase 2, testing for VL will focus on targeted patients and those for 2nd VL follow up.

7. Preliminary findings Reduced Turnaround time (TAT):
Turnaround time within the lab for all 3 sample types
Reduced Turnaround time (TAT):
Conventional lab average TAT is around 14 days for VL/EID but with integration to a near-POC , the in lab TAT was reduced:
68.2% of EID tests, 51.7% of TB tests and 28.1% of viral load tests run within 24hrs and all samples within 7 days.
Action Plan: Set TAT targets for actionable results; TAT from sample collection to result received by the clinician and acted upon.
Test volume increased, improved access
In total 2,975 samples (EID +VL) apart from the routine TB testing
Not all samples are onsite samples, 51% of samples were referred from surrounding health facilities.

8. Several key challenges still remain to be addressed for effective integration
Investment will need to be put in some of the to reduce downtown e.g. air conditioners to control temperature, extra fridges to stores samples, solar panels to provide power during times of power cuts.
Condition of infrastructure 1 2
Some of the current machines are older than 5 years, improved vigilance and better S&M services will reduce downtime due to breakdowns.
Service and maintenance 3
Routine Staff Rotation
Redeployment of lab staff trained in EID and VL testing on the GeneXpert results in testing downtime until new personnel can be trained hence the need to train larger pools of testing staff. 4
Waste Management
All the pilot facilities do not have incinerators which go up to the 1000°C required to safely dispose of used cartridges. Waste has to be moved to the health facilities with the capacity to incinerate. There is need for a more sustainable solution

9. Key Recommendations for successful integration moving forward
Policy
There is a need to revisit the use of GX devices in the country at a policy level if the HIV/AIDS Program is also to effectively utilize the same machines originally procured for TB testing only.
Effective policy will also enable the AIDS and TB programs to realize synergies through cost savings from shared costs like setup, S&M, supportive supervision, supply chain management and HR.
Infrastructure
Investment on infrastructural upgrade would need to be considered in the event of national scale up.
Service and Maintenance
New and innovative S&M services will be required to cover the increased usage and avoid frequent breakdown – considering the varying ages of the devices in country. Integration provides an opportunity to leverage volumes and funding across programs for better service provision.

10. In conclusion:
The next phase of the pilot will be looking to assess the patient impact and acceptability of integrated testing and continue to determine the optimal flow of patients, samples and results.
The key point here is to highlight the benefits to the patients:
Travelling shorter distances for VL - local facilities,
Reduced visits due to same day consultation
Viral load and EID faster results/shorter TAT
Using existing Genexpert is a great way to implement decentralized VL and EID testing to increase access to testing and meet 90x90x90 targets at reduced costs.