1. Early Infant Diagnosis - Impact of the point-of-care testing approach with Alere(tm) q HIV-1/2 Detect
9th IAS Conférence on HIV Science (IAS 2017)
23-26 July 2017 | Paris, France
Palais des Congrès, 2 Place de la Porte Maillot, Paris
Reuben Mwenda: MSc (Med Micro), HDMLS, DMLS, CLT
ASLM Ambassador
Ministry of Health
Malawi
Government of Malawi

2. Presentation Outline Background information POC EID pilot1
Background information 2
POC EID pilot 3
Testing beyond the pilot 4
Differentiated care models for EID 5
Balancing POC and conventional testing 6
Operational challenges 7
Conclusion and way forward

3. Background Information: Malawi HIV Statistics1
Malawi has a population of 17,750,0001 2
Approximately 1.1 million people are living with HIV2 3
About 3,339,162 people were tested for HIV in 20163 4
There are 679,056 people alive and on ART3
Viral suppression rates among children (0-14 years) and adults (15+ years) is 62% and 90%, respectively3 5
Sources:
UN Data
UNAIDS Estimates
Malawi HIV Quarterly Reports for Q1, Q2, Q3 & Q4 of 2016

4. Background Information: Malawi EID Program1
Malawi has 671 health facilities that do HIV exposed child follow-up 2
Dried Blood Spot (DBS) sample collection for EID is done in all these sites 3
The country has 10 sites centralized molecular labs with conventional machines that provide EID testing 4
About 43,784 EID tests were done in 20161
Source: 1. LIMS Data accessed at on 14 July 2017 at 11:10 AM

5. POC EID Pilot: Loss to Follow Up (LTFU) of HIV Exposed Infants (HEI)
 In Malawi there was high LTFU of HEI before the implementation of POC EID
EID Program Snapshot, Q2 2015
~55% of expected HEI
~36% of results returned within 2 months
~57% of results returned to patients
~48% of infected infants initiated
ASLM Abstract Number: , Significantly improved Antiretroviral Therapy initiation rates after the implementation of Point Of Care Early Infant Diagnosis

6. POC EID Pilot: Design Objectives
To assess the operational characteristics of a POC device to inform an optimal national deployment strategy before scale up is done
To understand the patient impact of implementing POC EID technologies on test turnaround times, retention, and ART initiation
Methods
Period: from September 2015 to June 2016
Sites Selection: devices were placed at 7 sites
Baseline data: collected retrospectively for same number of months preceding EID POC implementation at POC sites
Study Population
Babies less than 12 months of age

7. POC EID Pilot: Site Selection
Inclusion criteria:
High burden: HIV prevalence among pregnant women >10% at each site
High volume: High EID volumes maximize patient impact based on 2014 LIMS data
Strong buy-in: Sites expressed interested in implementing POC EID
Patient / clinic flow: Facility-specific patient / clinic flow informed device placement strategies
Central
Hospital
District Hospital
Primary Health Centre 1 2 3
Device placement strategies within a facility
Testing at various entry points
In-patient testing
Testing from mother-infant-pair (MIP)clinic
Testing all HEIs in peripheral low volume sites
Device in a common lab
Device in pediatric ward
Device in MIP clinic
Device shared between 2 primary HCs or networked with peripheral sites 1 2 1 2 3 3

8. POC EID Pilot: Demographic Data
 The total number of infants tested was 1,752 (both POC and centralized testing)
Age of infants
<2 months
2-6 months
6-12 months
>12 months
Missing info
Proportion
56% (n=987)
31% (n=536)
11% (n=191) 1%
(n=21)
(n=17)
Sex
Male
Female
Missing info
Proportion
46%
(n=799)
50%
(n=870) 5%
(n=83)

9. POC EID Pilot: Device Utilization
 Device utilization: District hospitals appear to be the “sweet spot” for POC EID, while device sharing by rural health centres can maximize device utilization as well
Device utilization by type of facility during the study period
Facility Type by Device Placement
Number of POC Tests/Site
Proportion of Total Tests
ART clinic - Central Hospital
103
13%
Pediatric Ward -Central hospital 82
10%
Lab – District hospital
216
27%
Mother Infant Pair Clinic – District hospital
156
20%
Rural Health Centre 61 8%
Rural HC Sharing
171
22%
Total
789
100%

10. POC EID Pilot: Entry Point Deployment
 POC is likely to help find more HIV positive infants when deployed in the pediatric wards
Proportion of HIV Positive Infants by entry point
within a clinic during the study period
Entry Point
HIV Test Result
Total
Positive (%)
Positive
Negative
PMTCT/ART/MIP 17
677
694 2%
Pediatric Ward - Inpatient 22 23 45
49%
Pediatric Ward - Outpatient 6 44 50
12%
744
789 6%

11. POC EID Pilot: Patient Impact
 POC EID allows for significantly reduced test turnaround times along the testing and treatment cascade as well as improved ART initiation rates
Conventional
POC
TAT: sample collection to results received
56 days
Same day
TAT: sample collection to ART initiation (positive infants only)
38 days
Proportion of results received within 60 days
41%
100%
Proportion of HIV+ patients starting ART
45.8%
91.1%
ASLM Abstract Number: , Significantly improved Antiretroviral Therapy initiation rates after the implementation of Point Of Care Early Infant Diagnosis

12. Perceptions of Healthcare Workers
POC EID Pilot:
Perceptions of Healthcare Workers
A total of 32 healthcare workers were trained on how to operate Alere q
A sample of 20 healthcare workers were interviewed to get their perceptions on Alere q
Type of Cadre
Clinician 5
HSAs 3
HTC Counsellor 6
Lab Tech 1
Microscopist
Nurse/Midwife
Others-HDA
Total 20

13. POC EID Pilot: Perceptions of Healthcare Workers
HCW who found all aspects of running tests relatively easy
How easy is the test to perform?
Respondents: 20
Heel-stick
Cartridge filling
Inserting cartridge in the device
Ejecting the cartridge
Interpreting the results
Average 5%
Easy
30%
45%
35%
40%
Very easy
65%
Very easy
55%
60%
70%

14. POC EID Pilot: Perceptions of Healthcare Workers…
POC tests have helped facilities better treat and manage HIV+ infants
The POC test helped facility better treat and manage HIV+ infants
No. of HCW
Percentage No 1 5%
Yes 19
95%
Divided opinion on device portability
Portability of device
No. of HCWs
Percentage No 9
45%
Unsure 2
10%
Yes

15. POC EID Pilot: Perceptions of Healthcare Workers…
Non-lab staff are suitable to run tests
Non lab-staff suitable to run the test?
No. of HCWs
Percentage No 1 5%
Yes 19
95%
Test is suitable at all facility levels
At which facility level of care the test is suitable?
No. of HCWs
Percentage
All levels 11
55%
Central Hospitals 1 5%
Health center 8
40%

16. Testing Beyond the Pilot
 In Sep 2015-April 2017 a total of 2,542 EID tests were done
Total Tests
Positive Tests
Negative Tests
Totals
2,542
146
2,396
Percentage
100%
5.74%
94.26%

17. Differentiated Care Models for EID
Need to retain capacity to respond to patients who present with advanced disease, and are at heightened risk of morbidity and mortality4
Shorter TAT has a positive effect on provider initiated testing and counseling (PITC)5
“In generalized epidemic settings, infants and children with unknown HIV status who are admitted for inpatient care or attending malnutrition clinics should be routinely tested for HIV” 6
Generally expedited DNA PCR testing was used on conventional machines and TAT was more than 3 days
 Therefore, conventional EID testing would be more suitable for stable HIV exposed infants while unstable/sick HIV exposed infants would more likely require expedited model of testing
 Alere q has been used to provide a differentiated care model for patients needing expedited testing, same day results so that clinicians can decide the next course of action
4. Mortality of HIV-1-infected patients in the first year of ART: comparison between low-income and high-income countries..Lancet, 2006;367(9513):817–24;
5. McCollum et al, 2014; 6. Highlights: AIDS 2016 ASLM Satellite Session: Implementing POC for Early Infant Diagnosis Testing;

18. Differentiated Care Models for EID…
 POC EID minimizes loss to follow up by turning multiple clinic visits into one visit and by reducing the turnaround time to same day results
Same day
EID Test performed on site
Test result received, recorded
Enrollment of HEI to HIV care
Fill lab requisition for EID
HIV+ Mother and Infant 4 2 3 5 1
Same day
ART initiation
Clinical consultation 7 6

19. Balancing POC and Conventional Testing
Malawi has 10 centralized labs providing EID and VL testing
Based on POC mapping results, POC can cover 25% of national EID testing needs and conventional and near POC can cover 75% of the remaining need
 POC EID sites also rely on conventional laboratories for duplicate testing in EQA

20. Operational Challenges Challenges During Implementation of POC EID
Proposed Solutions
Tracking ART initiation of referrals
When infants are managed by a referring facility
Testing facility should initiate HIV positive infants on treatment and advise mothers to collect subsequent refills at the referring facility
Poor documentation and weak linkages
Children discharged/transferred out from inpatient care immediately after a test and before initiating treatment
Intensify training of healthcare workers on proper documentation
Institute electronic patient tracking systems
Device down times
Absence of a local service and maintenance point
Build and strengthen local capacity

21. Operational Challenges Challenges During Implementation of POC EID
Proposed Solutions
Short shelf-life of test cartridges
Current shelf-life for POC cartridges is 9 months as compared to 18 months for HIV rapid test kits
Advocate for longer shelf-life (18 months)
Delayed in-patient initiation
Delayed initiation of treatment among HIV-positive infants receiving in-patient care due to unstable medical conditions
Strengthen follow up mechanism ts to make sure that there is no delay in initiation of treatment as soon as the patient gets stable

22. Conclusion and Way Forward
ART initiation rates were significantly improved with the implementation of POC EID testing compared to conventional laboratory-based testing
Turnaround time has greatly improved
Testing infants in pediatric wards yielded significant positive results therefore placement of the devices in these sites is vital
Clinical management of infants found outside of PMTCT is critical and needs to be thought through to ensure they are linked to care accordingly
Wider decentralization of POC EID would allow for wider access to EID testing, support increased ART initiation, and improve patient outcomes
Non-laboratory staff can successfully implement POC EID
National deployment strategy for POC is important; MOH is in the process
Overall, this is great input to the attainment of global targets

23. UNITAID UNICEF CHAI CDC/PEPFAR URC USAID ASLM MSF EGPAF
Acknowledgements
UNITAID
UNICEF
CHAI
CDC/PEPFAR
URC
USAID
ASLM
MSF
EGPAF

24. Feedback? Questions?
Agenda
Zikomo!
Thank You!
Government of Malawi