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)

Technical protocols Selection of technologies Technical and field evaluations Pilot design Technical protocols Selection of technologies Technical and field evaluations Pilot design Pilot in 7 health facilities Impact evaluation Pilot in 7 health facilities Impact evaluation 2012 National scale-up 110 health facilities in % of ART patients with access to POC CD4 National scale-up 110 health facilities in % of ART patients with access to POC CD4 Implementation in one province Strategy for national scale-up Implementation in one province Strategy for national scale-up Evaluation of other technologies Implementation research Planning of implementation Evaluation of other technologies Implementation research Planning of implementation Timeline for Evaluation and Implementation of POC CD4 in Mozambique

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 2011: Pilot in 1 province : 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

Effective Implementation of POC Testing Requires Coordination Provincial Implementation INSMOH Prov. Gov. Prov. Partners

Provincial Coordination Site Matrix POC ToT Train Sites Site Introduction Continuous Monitoring Preliminary site list is generated from matrix tool. Provincial stakeholder meetings, site list is validated. Central team trains provincial trainers. Provincial trainers train and certify POC operators. Sites are mentored. New patient flow diagrams implemented and sites begin to apply POC. 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 Utilizatio n 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 Revise policy and normative guidance Cost and cost-effectiveness of POC testing Testing guidelines Clinical algorithms Decentralization of services Focus AreasKey Improvements Improve operational systems Product regulation Supply chain Training Quality Assurance Drive streamlined clinic services New staff cadres and shifts Patient scheduling Bundled procedures Improved medical records Decentralization and retention Initiatives Community-based testing Linkage to care Integrated services Adherence tools From: Jani & Peter (2013)

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. The Access to Quality Testing in Hard-To- Reach Areas Is Possible