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

Presentation Outline Background information POC EID pilot 1 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

Background Information: Malawi HIV Statistics 1 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 http://data.un.org/CountryProfile.aspx?crName=malawi UNAIDS Estimates http://www.unaids.org/en/regionscountries/countries/malawi Malawi HIV Quarterly Reports for Q1, Q2, Q3 & Q4 of 2016

Background Information: Malawi EID Program 1 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 www.eidmalawi.org on 14 July 2017 at 11:10 AM

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: 2605753, Significantly improved Antiretroviral Therapy initiation rates after the implementation of Point Of Care Early Infant Diagnosis

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

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

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)

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%

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%

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: 2605753, Significantly improved Antiretroviral Therapy initiation rates after the implementation of Point Of Care Early Infant Diagnosis

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

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%

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

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%

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%

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;

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

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

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

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

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 90-90-90 targets

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

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