1. Tools for Viral Load Implementation
Michele Montandon, MD
U.S. Centers for Disease Control and Prevention
Monday, July 22, 2019

2. Disclosure
No conflicts of interest to declare

3. Viral Load Coverage, PEPFAR 2017 and 2019

4. Overview of Tools
Tools to Monitor the HIV Viral Load Cascade & Identify Gaps
PEPFAR Viral Load Summary Dashboard
Viral Load Implementation Monitoring Tool
Viral Load/Infant Virologic Testing Laboratory Scorecard
Clinical Viral Load Service Quality Tool
Tools to Support Implementation & Address Gaps
Laboratory Network Optimization strategy and tools
High Viral Load Register
Enhanced Adherence Counseling flipcharts
Training videos for DBS collection for Viral Load

5. Monitoring & Gap Identification Tools

6. PEPFAR Viral Load Summary Dashboard
Purpose
To provide visualizations of standard PEPFAR VL quarterly indicators at national, subnational and site levels
Why is it useful?
Allows for identification of gaps in VL coverage and suppression
Based on required indicators  data available for all PEPFAR countries
Example country:

7. VL Implementation Monitoring Tool
Purpose
To highlight indicators across the HIV VL cascade that can be used to monitor leaks across the cascade and turnaround time
Why is it useful?
Helps identify clinics, labs, or regions identify bottlenecks and target interventions to improve access to and quality of VL testing
Indicators can be incorporated into national monitoring tools and/or dashboards

8. VL Implementation Monitoring Tool: Turnaround Time (TAT)
Nine indicators and eight TATs allow identification of specific gaps
# of VL tests requested
TAT 1
# of patients with sample collected for VL testing
TAT 2
# of VL specimens received at the lab
TAT 3
# of VL samples tested
TAT 4
# of VL results released from lab
TAT 5
# of VL results received at the clinic
TAT 6
# of VL results entered into medical record
TAT 7
# of patients notified VL result is ready
TAT 8
# of VL results returned to patient

9. Utilizing Detailed Setting-Specific Data for Real-Time Program Improvement

10. Viral Load/Infant Virologic Testing Laboratory Scorecard
Purpose:
To monitor the quality of viral load testing across nine different domains
Why is it useful?
This scored checklist identifies gaps, tracks improvement and remediation, and measures efficiencies in viral load laboratories

11. Laboratory Scorecard Sections#
SECTION
TOTAL POSSIBLE POINTS
Pre-testing 1
Personnel 11 2
Physical Facility / Environment 14 3
Safety / Waste Management 12 4
Purchasing / Inventory 8 5
Sample Management
Testing 6
Equipment 7
Process Controls 21
Post-testing
Documents/Records - Results 19 9
Internal Quality Audits – Quality Indicators – Continual Improvement
OVERALL SCORE
106
Example: National Public Health Laboratory

12. Clinical Viral Load Service Quality Tool
Purpose
Focused assessment of critical steps in the VL cascade, including the laboratory-clinic interface, documentation of VL results in patient files, and management of non- suppressed VL results
Why is it useful?
Can be used on initial and follow-up visits to clinical facilities
Site-specific findings and observations used to develop a VL service quality improvement plan
Sections
VL testing status and lab-clinic interface
Eligible patients have documented VL testing and results
Steps in VL process: VL requisition form completion, VL sample collection, Clinic VL results receipt and documentation
High VL results management

13. Tools to Support Implementation and Address Gaps

14. Laboratory Network Optimization
The process of making something (such as a design, system, or decision) as fully perfect, functional, and effective as possible
Why do we need laboratory network optimization?
Despite an excess in laboratory and POC instrument capacity, we still see low viral load testing coverage and long turnaround times across the viral load cascade

15. Basic Laboratory Network Optimization Strategy
Purpose: To identify strengths and gaps in the current laboratory network and to ensure a robust and efficient network for viral load and EID testing
Capacity
Efficiency
Integration
Assess whether there is sufficient instrument capacity in place to meet the current and future testing demands
Identify areas within the current network that are not working optimally (e.g. long turnaround times, backlogs and cost inefficiencies)  develop targeted solutions
Examine opportunities for integration, e.g. HIV EID and TB

16. Basic Laboratory Network Optimization: Associated Tools
Viral Load Instrument Capacity Calculator
LabEQIP is a GIS-based solution that helps
improve laboratory network efficiency &
advance quality service delivery through
data-driven optimization.
Step-Wise Guide to Plan for POC Integration

17. Step-wise Guide to Plan for POC Integration
Purpose: Pu
To provide an approach for integrating near-POC and POC testing for EID into existing HIV and/or TB laboratory-clinic networks
Why is it useful?
Uses setting-specific data to assess linkages and opportunities for integration at PMTCT/ART facilities
Helps decision makers assess the need and readiness of their clinic-laboratory systems for TB/POC EID integration
Can easily be adapted in future to incorporate POC VL

18. Setting-specific data to examine integration potential
Clinic Data
Facility
HIV+ Pregnant Women PMTCT_STAT_POS
# of infants tested w/in 2 mo of birth PMTCT_EID
Infant HIV Testing Gap
# of infants w/ pos result PMTCT_EID_POS
# of infants w/ unknown result PMTCT_EID Unknown
Enter facility name
Enter raw numbers from 2018
Automatic calculation: PMTCT_STAT_POS - PMTCT_EID
2522
165
151 14 1 84
1295 97 54
1184
260
109 43
1125
291
141
150 41
737
106 77 29 30
2153
212
127 85 3 27
929 64
100
-36 18
1116
455
462 -7 6 15 17 47
134
-87 8
4503 32 71
-39 12
1304 86 76 10
Laboratory at site
High Throughput VL testing
High Throughput EID testing
TB Xpert
EID Xpert
VL Xpert
GeneXpert Testing Volume
GeneXpert Testing Capacity
Current GeneXpert Utilization
Theoretical GeneXpert Utilization
Enter "Yes" or "No" for current testing ongoing
Enter total tests run in 2018
Enter total number of tests possible per day (assuming a 4-module GeneXpert running for 8 hrs efficiently can run a max of 12 tests).
Automatic calculation: current testing volume/instrument capacity
Automatic calculation: (# of HIV-positive pregnant women + current GeneXpert testing volume) /Current GeneXpert instrument capacity No
Yes NA
#VALUE!
3000
4000
0.75
77%
1750
0.4375
51%
46%
1250
31%
37%
1000
0.25
27%
1001
26%

19. High Viral Load Register
Purpose
To track patients with non-suppressed VL and document enhanced adherence counseling sessions, follow-up VL test results, changes in ART regimen and outcomes
To provide the data for high VL cascade analysis with identification of facility-level gaps
Section of High VL Register
High VL Cascade Analysis

20. Enhanced Adherence Counseling Flipcharts
Purpose
To provide patients with information about the meaning and significance of VL results
To help patients with non-suppressed VL identify and address adherence barriers
To support different cadres of health care workers in the utilization of VL results to optimize patient management

21. Lessons learned and recommendations
Monitoring tools are critical to ensure data-driven site and program level improvements towards the achievement of goals.
Tools are iterative and adaptable: Many were developed from country experience and continue to be further adapted.
Standardized PEPFAR tools and locally adapted tools complement one another
VL optimization should be considered within the broader context of the health system and laboratory network.
Improving VL coverage and quality is a multi-disciplinary effort involving laboratory, clinical, strategic information, and supply chain colleagues across all phases of planning, implementation, monitoring and program improvement.

22. Resources Viral Load Scale Up Tools: ASLM and CDC collaboration
VL/IVT Laboratory Scorecard
Training videos on DBS collection for VL testing
Viral Load Toolkit: ICAP and CDC collaboration
VL Facility Assessment Tool
High VL Register
Enhanced Adherence Counseling flipcharts
National Viral Load Dashboards
Kenya:
Uganda:

23. Acknowledgements CDC-Atlanta
Heather Alexander
Erin Rottinghaus
Dennis Ellenberger
Helen Chun
Mackenzie Hurlston
Rituparna Pati
Spencer Lloyd
Kiren Mitruka
Nadia Solehdin
Niko Gaffga
Stephanie Hackett
Laura Viens
Office of the Global AIDS Coordinator (OGAC)
George Alemnji
PEPFAR Interagency Collaborative for Program Improvement (ICPI)
Yaa Obeng-Aduasare
Michele Sherlock-Williams
USAID
Ministries of Health and PEPFAR country teams
ASLM
ICAP
This project has been supported by the Centers for Disease Control and Prevention (CDC). The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the CDC.

24. Thank you!