Technical and Operational Considerations for Scaling Up HIV Viral Load Testing John Nkengasong, PhD Associate Director for Laboratory Sciences & Chief, International Laboratory Branch Division of Global HIV/AIDS CDC , Atlanta, Georgia Center for Global Health Division of Global HIV/AIDS

Phased Implementation of Viral Load Testing Phase I: Planning Policies and Leadership Harmonization Algorithm Mapping and Forecasting Assess Capacity Costing Specimen and Product Selection Equipment Procurement Phase II: Scale Up Phase In Human Resources Training and Supervision Quality Management System Phase III: Sustainability Partner Harmonization M&E Data Collection Operational Research

Phase I: Planning Policies and Leadership Harmonization Algorithm Mapping and Forecasting Assess Capacity Costing Specimen and Product Selection Equipment Procurement

Developing an Algorithm for Monitoring Viral Load • Frequency of viral load testing • Definition of viral failure • Repeat testing with viral failure • Specimen type • Population-specific testing algorithms • Projected number of people on ART

Framework for Developing a Sustainable Viral Load Network Specimen Referral Key Elements for Viral Load Networks Sustain Program Implementation Equipment Information Management Systems Quality Management Systems M & E Technology Evaluation Policy & Strategic Planning and Coverage Impact on Patient Monitoring, Treatment Adherence, and Viral Load Suppression

Performance Characteristics of DBS Viral Load Testing by Different Platforms [at 1000 Copies/mL] VIRAL LOAD ASSAY Sensitivity (mean %) Specificity (mean %) n Abbott Molecular: Abbott RealTime HIV-1 (manual, m24sp and m2000sp) assays with m2000rt platform 95 92 1529 Biocentric: Generic HIV Charge Virale 55 531 bioMérieux: NucliSENS EasyQ® HIV-1 v2.0 84 1062 Roche Molecular Systems: COBAS® AmpliPrep/Taqman® HIV-1 Test, Version 2.0 [free virus elution protocol] 81 97 229 Siemens VERSANT® HIV-1 RNA 1.0 Assay (kPCR) 91 88 144

Advantage of Using Plasma or DBS for Viral Load Testing Plasma Specimens Gold standard to determine viral failure Requires stringent processing and storage conditions Accurate on all platforms DBS Specimens Easy preparation using whole blood Minimal transportation requirements; not considered biohazardous Not as time and temperature sensitive as whole blood or plasma

Technologies for Scaling Up Viral Load Networks Key Messages Options for viral load scale up Selection criteria Impact of point-of-care technologies Dried blood spots Centralized platforms Point of care

Phase II: Scale Up Phase In Human Resources Training and Supervision Quality Management System

Quality Management System for Viral Load Networks Proficiency testing and quality control Continual training and competence assessment Quality managers Data quality checks Monitoring and evaluation system

Phase III: Sustainability Partner Harmonization M&E Data Collection Operational Research

Harmonization Among Partners Coordination among all stakeholders Harmonize existing capacity Streamlined efforts Joint targeted support

Concluding Remarks Developing a robust and sustainable HIV viral load testing network involves: Leadership of Ministries of Health Systematic approach for implementing viral load networks (Phases I-III) Critical role of partnerships A sustainable viral load network improves: patient outcome, treatment adherence, and viral load suppression.