Point-Of-Care CD4 Testing to Improve Patient-Important Outcomes: a Health System Perspective Ilesh V. Jani, MD PhD Instituto Nacional de Saúde Maputo, Mozambique
After Introduction of POC CD4 LTFU before CD4 staging dropped from 57% to 21% • Observational cohort study in 4 primary health care facilities in Mozambique • Comparison of before and after implementation of POC CD4 counting From: Jani (2011)
After Introduction of POC CD4 ART Initiation Rate Increased from 12% to 22% From: Jani (2011)
After Introduction of POC CD4 Time to ART Initiation Reduced from 48 to 20 Days From: Jani (2011)
Timeline for Evaluation and Implementation of POC CD4 in Mozambique • Technical protocols • Selection of technologies • Technical and field evaluations • Pilot design • National scale-up • 110 health facilities in 2013 • 25% of ART patients with access to POC CD4 • Pilot in 7 health facilities • Impact evaluation • Evaluation of other technologies • Implementation research • Planning of implementation • Implementation in one province • Strategy for national scale-up 2011 2010 2015 2012 2013 2009 2014
Where and How to Implement POC CD4? • Co-existence of POC and conventional instruments in the same network • Development of a tool that considers 7 objective criteria for CD4 POC deployment • Implementation based on lessons learned during a provincial pilot • Operational issues (training, quality control, supervision) are key • Clinic workflow and health system issues are a significant challenge
Point-Of-Care Testing Is Not Error Proof From: Plebani (2009)
Implementation of Point-Of-Care Tests Is Not Always Done Efficiently From: Jani (2011)
National Scale-Up of POC CD4 11 9 • 2011: Pilot in 1 province • 2012-2013: 110 health facilities nationally • 2013: ~25% of patients in care with access to POC CD4, >400,000 POC CD4 tests • Multiple partner effort and cooperation with COORDINATION AT NATIONAL LEVEL 14 15 11 8 13 12 9 2011 2012 9 2013
Effective Implementation of POC Testing Requires Coordination
Site Matrix Preliminary site list is generated from matrix tool. Provincial Coordination Provincial stakeholder meetings, site list is validated. POC ToT Central team trains provincial trainers. Train Sites Provincial trainers train and certify POC operators. Site Introduction Sites are mentored. New patient flow diagrams implemented and sites begin to apply POC. Continuous Monitoring EQA, site supervision, remote monitoring.
Combined Off-site Regional Training with an On-site Workshop for POC CD4 • National master trainers from the INS led a regional training-of-trainers in each province • 4-8 regional trainers were trained per province • Regional trainers led several 5-day off-site operator trainings in their respective provinces • Following the operator trainings, trainers conducted a one-day on-site workshop at each site receiving a POC device POC testing extends laboratory services to non-classical settings - the laboratory perspective is critical!
National Managers Monitor Real-time Utilization Data Modems transmit data daily on device utilization Managers target facilities for remote and on-site follow-up Follow-ups help minimize errors and downtime Follow-up triggers: High Error Rates Low Utilization Device Not Operating User Not Certified Not Running Controls
External Quality Assessment Helps to Identify Sites with Potential Problems Data from Mozambique’s National EQA for CD4 Counting
Final Considerations • POC tests have an important role in increasing access to health care and improving patient-important outcomes • Evaluations and implementation should be conducted under a health system perspective (and not a given health facility or specific NGO in mind) • Smart partnerships and strong coordination are strategic to the success of POC diagnostics • The final impact of POC assays will be shaped by various factors, especially by weaknesses of health systems
Targeted Improvements Necessary to Address the Challenges for Expanded Testing Focus Areas Key Improvements 1 Revise policy and normative guidance • Cost and cost-effectiveness of POC testing • Testing guidelines • Clinical algorithms • Decentralization of services 2 Improve operational systems • Product regulation • Supply chain • Training • Quality Assurance 3 Drive streamlined clinic services • New staff cadres and shifts • Patient scheduling • Bundled procedures • Improved medical records 4 Decentralization and retention Initiatives • Community-based testing • Linkage to care • Integrated services • Adherence tools From: Jani & Peter (2013)
The Access to Quality Testing in Hard-To-Reach Areas Is Possible Setting: 20,000 pop. in the shores of Lake Niassa. Strategy: Each 2 months, 2 community workers, without formal health qualifications, perform a circuit of 220km on foot and/or kayak to serve 8 villages.