1. Comparing Conventional to Point-of-Care (POC) Early Infant Diagnosis (EID): Pre and post intervention data from a multi-country evaluation.
Flavia Bianchi, Valery Nzima, Addmore Chadambuka, Anafi Mataka, Gcinile Nyoni, Gilles Ndayisaba, Patricia Fassinou, Rhoderick Machekano, Emma Sacks, Rebecca Bailey, Rebecca Alban, Jean-François Lemaire, Jennifer Cohn
IAS Satellite Session
Paris, France
July 25, 2017

2. The authors have no conflicts to declare.

3. Overview Background and rationale for POC EID project
Baseline data (6 countries)
Interim data from POC use (6 countries)
Comparing conventional and POC EID on key service delivery indicators
Conclusions

4. Background
Survival of HIV-infected infants depends on a robust early infant diagnosis (EID) system
Turnaround time for conventional EID is typically between days
HIV infected, untreated infants have rapid disease progression and high mortality
Half of HIV-infected infants will die by age 2 if untreated
Integration of point-of-care (POC) EID testing into a country’s existing laboratory network could improve EID system functioning.

5. Goal and Purpose of the EGPAF POC EID Project
Goal: to increase the number of HIV-positive infants whose HIV status is known and facilitate early ART initiation.
Purpose: ensure that at-risk infants have timely access to HIV testing through scale-up of POC EID in the context of optimizing existing national EID networks
Working in 9 countries / 2015 – 2019

6. Description of EGPAF POC EID Project
Sites selected for programmatic purposes
Majority of sites EGPAF-supported
Site selection based on criteria agreed by MOH and EGPAF: Sites with ART access, consideration of access to conventional EID, platform placement at sites with EID demand >0.5/day
Hub-and-spoke model adopted or planned for 8 countries
Platform (either AlereQ or Cepheid Xpert) matched to site
Phased and monitored implementation: Initial phase of 6 months
First multi-country evaluation of key clinical and service delivery outcomes comparing routine POC EID to conventional EID.
Interim POC EID data from 6 countries: Cameroon, Côte d’Ivoire, Lesotho, Rwanda, Swaziland, Zimbabwe.

7. POC EID Placement Models
Stand-Alone Model
Hub-and-Spoke Model
Hub testing sites: provide testing for patients
at that site and for spoke sites
Spoke sites: regularly send samples to the hub
sites for POC EID testing
Stand-alone testing sites (without spokes): Receive samples directly from clients and perform POC EID tests on site

8. Optimizing Access and Platform Throughput Capacity

9. Monitoring and Evaluation Methods
Pre-intervention data (conventional EID) were retrospectively collected from facility registers from a sub-set of intervention sites
Purposive sampling of sites selected for intervention
10-20 sites per country
In each site, data retrospectively extracted from registers for 30 consecutive HEI who had a sample collected for EID
Intervention data (POC EID) were collected prospectively in all POC EID sites using a newly introduced POC EID Testing Form.

10. Conventional Laboratory EID Results for Primary Evaluation Outcomes
Country (number of conventional tests)
% Results received by Infant Caregiver
Median number of days [range] from blood collection to return of results to caregiver *
# of HIV-infected infants initiated on ART
Median number of days [range] between receipt of results by caregiver and initiation on treatment of HIV-infected infant
Cameroon (n= 240)
49%
35 days [9-381]
10/14
0 days [0-22]
CDI (n= 315)
64%
81 days [2-234]
4/5
0 days [0-32]
Lesotho (n= 269)
82%
63 days [13-410]
7/8
0 days [0-0]
Rwanda (n=600)
93%
34 days [3-366]
8/9
27 days [0-75]
Swaziland (n= 180)
61%
31 days [9-104]
0/2
N/A
Zimbabwe (n = 606)
83%
61 days [16-438]
21/31
0 days [0-6]
Total (n= 2210 at 73 sites)
77.4%
53 days
[2-438]
72.4% (50/69)
0 days
[0-75]
*Tests for which no date for caregiver result return was recorded were censored and not included in calculation of turn-around-time.

11. POC EID Results at Pilot Sites for Primary Evaluation Outcomes
Country (number of POC EID tests)
% Results received by Infant Caregiver
Median number of days [range] between blood sample collection and return of results to caregiver *
# of HIV-infected infants initiated on ART
Median number of days [range] between receipt of results by caregiver and initiation on treatment of HIV-infected infant
Cameroon (n= 666)
98.9%
0 days [0 – 33]
59/66
0 days [0 – 28]
CDI (n= 284)
99.6%
0 days [0 – 12]
8/10
0 days [0 – 4]
Lesotho (n= 803)
100%
0 days [0 – 38]
14/14
0 days [0 -7]
Rwanda (n=60)
0 days [0 – 35]
1/1
0 days (N/A)
Swaziland (n= 21)
0 days [0 – 0]
0/1
(N/A)
Zimbabwe (n= 940)
99.7%
0 days [0 – 31]
44/53
0 days [0 -6]
Total (n= 2774 at 95 sites)
0 days
[0 – 38]
86.8%
(126/145)
[0- 28] .
*Tests for which no date for caregiver result return was recorded were censored and not included in calculation of turn-around-time.

12. POC EID Placement Models
Stand-Alone Model
Hub-and-Spoke Model
Hub testing sites: provide testing for patients
at that site and for spoke sites
Spoke sites: regularly send samples to the hub
sites for POC EID testing
Stand-alone testing sites (without spokes): Receive samples directly from clients and perform POC EID tests on site

13. Comparing Testing and Spoke Sites
 Indicator
Testing Sites
(n = 28 sites)
Spoke Sites
(n = 67 sites)
% of results returned to caregiver
99.5%
99.9%
Median turnaround time from blood sampling to caregiver receipt of results
0 days (range: 0-33 days)
2 days (range: 0-38 days)
Median turnaround time from receipt of results to initiation on treatment
0 days (range: 0-28 days)
0 days (range: 0-7 days)
% HIV-Infected children initiated on treatment
88.5%
80.6%

14. Comparing Key Service Delivery Indicators:
What is the impact of POC EID?
Indicator
Conventional
Point-of-Care
% Reaching Caregiver:
77.4%
99.6%
TAT: Blood sample to receipt of results
53 days [2-438]
0 days [0 – 38]
TAT: Receipt of results to initiation
0 [0-75]
0 days [0 – 28]
% initiation on treatment
72.4%
86.8%
TAT: Blood sample collection to initiation on ART
51.5 [range 17 – 156]
0 [range ]
Cost per test result returned to caregiver*
$ USD
$ USD
*Based on The Global Fund’s total cost of ownership estimates reported in the April 2017 HIV Viral Load and EID Selection and Procurement Information Tool, and adjusted for a 77.4% return rate for conventional and a 99.6% return rate for point-of-care

15. Cost Per Test Returned
The price of diagnostic technologies for EID – both conventional and POC – should be a key consideration
Currently, the individual test price is higher for POC EID than for conventional EID
However, it is important to not only consider the cost of the test itself but also comprehensive operating costs of delivering EID testing services, as well as the rate of results return to caregivers
Cost per test result received may be considered a closer measure of the true value of a diagnostic
Cost per test result received are estimated to be approximately $ USD and $ USD for conventional and POC, respectively.

16. Limitations
We rely on routinely collected data; baseline data was pre-existing data…data quality remains an issue. But very invested in data quality assurance…watch this space.
The majority of sites are EGPAF sites, potential for bias.
Sampling of baseline sites was purposive…considered size of facility, volume, urban/rural.
Impact evaluation is forthcoming to help address some of these barriers.

17. Conclusions
POC EID shows improvement over conventional centralized testing on service delivery outcomes such as:
A greater proportion of infants obtained their results
Infants receive their results on the same day, rather than waiting 53 days
A higher proportion of HIV+ infants get started on ART
Same day ART initiation still observed (no delay)
Sample transportation over small distances (from spoke to hub sites) allows for similar performance than when patient is seen at testing site, and may be considered to increase access to EID
Cost per test result received by caregiver is similar between POC and conventional testing
HIV programs should consider use of POC EID to improve EID outcomes. 

18. Thank you