Point-Of-Care CD4 Testing to Improve Patient-Important Outcomes: a Health System Perspective

Ilesh V. Jani, MD PhDInstituto 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)

2009 2010 2011

• Technical protocols• Selection of

technologies• Technical and field

evaluations• Pilot design

• Pilot in 7 health facilities

• Impact evaluation

2012

• National scale-up• 110 health facilities

in 2013• 25% of ART patients

with access to POC CD4

• Implementation in one province

• Strategy for national scale-up

2013 2014 2015

• 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

• 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

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Effective Implementation of POC Testing Requires Coordination

Provincial Implementati

on

INS

MOH Prov. Gov.

Prov. Partne

rs

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 CD4National 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

utilizationManagers target

facilities for remote and on-site follow-up

Follow-ups help minimize errors and

downtime

Follow-up triggers:

High Error Rates

Low Utilizati

on

Device Not

Operating

User Not

Certified

Not Running Controls

External Quality Assessment Helps to Identify Sites with Potential Problems

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5.0CD4 Absoluto

SDI

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 Areas Key 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

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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