Tools for Viral Load Implementation

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? • Helpsidentify 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

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 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 • 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 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 Pu Purpose: • 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

19. High Viral Load Register Section of High VL Register High VL Cascade Analysis • 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

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 chaincolleagues across all phases of planning, implementation, monitoring and program improvement.

22. Resources • Viral Load Scale Up Tools: ASLM and CDC collaboration http://www.aslm.org/hiv-viral-load-testing/hiv-viral-load-scale-tools/ • VL/IVT Laboratory Scorecard • Training videos on DBS collection for VL testing • Viral Load Toolkit: ICAP and CDC collaboration https://icap.columbia.edu/tools_resources/viral-load-toolkit-english/ • VL Facility Assessment Tool • High VL Register • Enhanced Adherence Counseling flipcharts • National Viral Load Dashboards • Kenya: https://viralload.nascop.org/ • Uganda: https://vldash.cphluganda.org/

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!