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

Disclosure No conflicts of interest to declare

Viral Load Coverage, PEPFAR 2017 and 2019

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

Monitoring & Gap Identification Tools

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:

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

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

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

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

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

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

Tools to Support Implementation and Address Gaps

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

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

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

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

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 0.25025 26%

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

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

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.

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/

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.

Thank you!