pilot implementation of point-of-care cd4 counting in mozambique’s national health system
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Pilot Implementation of Point-Of-Care CD4 Counting in Mozambique’s National Health System. Ilesh V. Jani Instituto Nacional de Saúde Maputo, Mozambique. Acknowledgements. MISAU INS CHAI Provincial Health Authorities in Maputo City, Maputo Province, Gaza, Sofala and Niassa - PowerPoint PPT PresentationTRANSCRIPT
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.