Pilot Implementation of Point-Of-Care CD4 Counting in Mozambique’s

National Health System

Ilesh V. JaniInstituto Nacional de Saúde

Maputo, Mozambique

Acknowledgements

• MISAU• INS• CHAI• Provincial Health Authorities in Maputo City, Maputo

Province, Gaza, Sofala and Niassa• Implementing Health Centres• Anglican Church, Niassa Province• MSF-Belgium• MSF-Switzerland• ARK• UNITAID

The Use of Rapid Tests Allowed Dramatic Scale Up of HIV Counselling and Testing

2003 2004 2009 20100

200

400

600

800

1000

1200

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

3,500,000

Number of Sites

Year

Num

ber o

f Tes

ting

Site

s

Num

ber o

f Tes

ted

Clie

nts

Source: Ministério da Saúde, Moçambique

HIV Rapid Testing – Leaps and Hiccups?Proficiency Testing Programs Show That Error Rates Are

High in Some Settings

1 2 3 40.0%

5.0%

10.0%

15.0%

20.0%

25.0% False Positives and False Negatives

Errors in Final Result

% o

f Par

ticip

ating

Insti

tutio

ns

Number of Participations in the EQASource: Instituto Nacional de Saúde, Moçambique

Mozambique’s National Health System Adopted a Multi-Step Evaluation Process

for Point-Of-Care Technologies

Technology Selection

Technical Evaluation(Laboratory, Field)

Pilot Implementation(Site, Province)

Other Company Information

10%

Testing Method & Procedures

40%

Reagents, Consumables &

Supplies20%

TechnologyAttributes

30%

• Heat and Humidity• Type of Sample Tubes• Need for Centrifuge• Reagent & Control Preparation• Expiration Period• Reagent and Consumable Cost• Internal Quality Control

• External Quality Control• Daily Calibration Requirements• Number of Steps in Procedure• Type of Sample Required• Precise Sample Measurement

Requirements• Batching• Result Delivery• Result Storage• Instrument Connectivity• Waste Generation

• Service and Maintenance• Supply Chain and Distribution• Timing & Regulatory Status• Installation

• Description of technology and parameters

• Type of technology (disposable, handheld, tabletop)

• Technical Sophistication• Mobility & Size• Routine Maintenance Requirements

• Instrument Throughput• Power Source• Alternate Power Source Availability• Capital Cost of Equipment

30 criteria across 4

categories

How to Select Technologies to Evaluate?

Primary Health Care Nurses Can Accurately Perform CD4 Counts and Toxicity Monitoring Using Point-Of-Care Devices

Alere PIMA (Lab Techs) vs. BD FACSCalibur Alere PIMA (Nurses) vs. BD FACSCalibur

Limits of Agreement -314 to +257 Limits of Agreement -249 to +148

But training on capillary blood collection is critical!Jani et al. AIDS (2011)

Pilot Implementation Was Initially Done in Six Clinics and One Mobile Team

• Six primary health care clinics in urban and rural settings

• One mobile team in a remote rural area in the north of Mozambique

• Chart review for data collection performed at baseline and post-implementation

Point-Of-Care CD4 Counting Reduces Pre-Treatment Loss-To-Follow-Up

Baselin

e _x000d_(N

ov 2009)

Post-Pilo

t _x0

00d_(Mar 2

010)0%

20%

40%

60%

80%

100%

55.2%

92.9%

44.8%

7.1%

Access to CD4 No Access to CD4

Percent Of Patients Receiving CD4 Test Results

Baselin

e _x000d_(N

ov 2009)

Post-Pilo

t _x0

00d_(Mar 2

010)0%

20%

40%

60%

80%

100%

28.4%

79.4%

71.6%

20.6%

Return After CD4 No Return After CD4

Percent Of Patients ReturningAfter Initial CD4

A Mobile Team Successfully Operates in Northern Lake Niassa, Mozambique

Setting: population ~20,000, area 1,600 km2.

Strategy: Every 2 months, 2 community health workers, with no formal health qualifications, make a round trip of 220 km on foot or kayak, stopping at 8 health posts.

Cumberland et al. Poster TULBPE060; IAS 2011

Sites with POC CD4 Perform Well in the National Proficiency Testing Program

1 2 3 4 5 6 7 8 9 101112131415161718192021222325262728293031323334353638394041424345464748

-6.0-5.0-4.0-3.0-2.0-1.00.01.02.03.04.05.06.0

CD4 AbsolutoCD4 Percentual

SD

I

Sites with POC CD4

Sample QC49, average absolute CD4 count=400 cells/mm3

Source: Instituto Nacional de Saúde, Moçambique

A Pilot Implementation in Currently Ongoing in Mozambique’s Gaza Province

Main Objectives:

- Test an approach for the implementation of point-of-care CD4 counting from a health system perspective.

- Develop and validate tools to assist provincial authorities in scaling-up the implementation of point-of-care assays.

Provincial Coordinatio

n

Site Matrix

POC ToT

Train Sites

Site Introduction

Periodic Evaluation

Nov 2010

Dec 2010

Jan 2011

May 2011

Preliminary site list generated from a site selection matrix.

Provincial stakeholder meetings. Site list validated.

Central level team trains provincial trainers.

Provincial trainers train and certify local POC CD4 operators.

Sites mentored. New patient flow diagrams implemented. Sites begin to implement POC CD4.

Joint Stakeholder evaluation meetings. Discussion of lessons learnt. Road map for continuous improvement. Validation of tools.

Expected Outputs of theProvincial Pilot:

• Site selection tool• Implementation

process manual– Laboratory– Clinic– Logistics and supply

chain– Quality assurance

• Training curriculum• Recommendations

for division of responsibilities (national, provincial, local)

The Improvement of Access to CD4 Counting is Not Uniform Across All Clinics

NEW TECHNOLOGY IS NOT THE SOLE SOLUTION

Limiting Factors:- Limited human resources - Change of culture- Patient overflow - Patient education- Clinic workflow

93%

4% 3%

Matola Clinic

CD4 Result on timeNo CD4 resultTransferred with outdated CD4 result

76%

24%

Machava Clinic

OBRIGADO!

Ultimately, sucessful implementation of point-of-care diagnostics will be about changing health systems, creating a new health care culture and shifting responsibilities to primary health care level.

In the coming years we will need to learn fast through implementation research.