Catalyzing Expanded Access to Early Testing, Care and Treatment among HIV-Exposed Infants
About the Project
Globally, more than 1.8 million children are living with HIV. Peak mortality for infants with HIV occurs between 6 and 8 weeks. While the World Health Organization (WHO) recommends that all children exposed to HIV get tested within the first two months of life, only half of the infants exposed to HIV have access to early infant HIV diagnostic (EID) screening. Fifty percent of infants who are tested never receive their results and therefore unable to access lifesaving treatment. Without treatment, 80% of all children living with HIV die before the age of 5.
In collaboration with Unitaid, and other stakeholders, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) developed a flexible and country-driven approach to ensure successful implementation of a complex and ambitious project to expand access to early diagnosis and treatment for HIV-infected infants. This four-year, US $63 million project is funded and supported by Unitaid and aims to increase the number of HIV-positive infants whose HIV status is known in order to facilitate early antiretroviral treatment (ART) initiation. The project will achieve this through the strategic placement of point-of-care (POC) EID technology in nine countries: Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland, Zambia, and Zimbabwe.
Through this project, EGPAF will increase the number and percentage of infants and caregivers receiving HIV test results; decrease the turn-around time of results from test to return of result to caregiver; decrease the number of days from HIV diagnosis to ART initiation for HIV-infected infants; and increase the number of children on life-saving treatment.
This project takes a four-step phased implementation approach both at global and country level. The preparation phase is a crucial period where the necessary conditions for placing POC EID in the sites are assessed. This includes gaining an in-depth understanding of where POC instruments can be best placed to fill gaps within the conventional laboratory network to optimize the use and clinical impact of EID testing. The identification of potential POC EID sites is based on an analysis of historical site-level data such as testing volume, positivity rates, turnaround time from sample collection to return of results, sample transportation networks, and geographic proximity or referral models to expand the access to EID testing (using hub [major testing centers] and spoke [smaller, community health settings] models). The analysis of potential POC EID sites, and the most adequate platform for each site, is presented and discussed with each ministry of health and national technical working groups. Subsequently the adequate POC EID technology is procured and POC platforms are placed in selected sites under the direction of the ministry of health.
During the pilot phase, sites are enrolled in phases to implement the POC EID testing devices. This phased approach allows to document and share lessons learned before scaling up to full implementation in all selected sites across nine countries.
Throughout the whole project, but especially in the transition phase, the project team will be working closely with ministries of health, other implementers and funders to develop and implement transition plans in each country to ensure a seamless transition of the project to national authorities and thus ensure the sustainability of this work. Working hand in hand with the ministries of health, EGPAF will generate and share data and lessons learned through routine project monitoring and formal evaluation studies with the World Health Organization and other partners.
This initiative aims to increase EID testing coverage in the nine project countries. It will increase the POC EID market share and decrease the cost of EID testing within each of these countries (making HIV testing and diagnosis of infants more accessible). During the four-year project period (August 2015 through July 2019), EGPAF anticipates testing over 250,000 infants and identifying 14,600 HIV-positive infants. With the assumption that 90% of HIV-positive infants will be initiated on ART and 90% will be virally suppressed, 13,000 HIV-positive infants will be initiated on ART. Through rigorous ongoing evaluation activities, the project will produce and share valuable evidence with the global HIV community regarding the feasibility, utility, and cost of utilizing POC technology for EID.
- Fact Sheet: Catalyzing Expanded Access to Early Testing, Care and Treatment for HIV-Exposed Infants
- Fact Sheet (French):Accroitre l’acces aux depistage precoce, soins et traitement des nourrissons exposes au VIH
- Fact Sheet: Catalyzing Expanded Access to Early testing and treatment in Lesotho
- Press Release: Unitaid and Elizabeth Glaser Pediatric AIDS Foundation Launch Initiative to Significantly Scale Up HIV Diagnosis Among Infants in Africa
- Media Advisory: The Elizabeth Glaser Pediatric AIDS Foundation and Unitaid Release Promising Results from the Use of Innovative Point-of-Care Early Infant Diagnosis of HIV
- Issue Brief: Quality Products to Deliver Quality Care: Monitoring the Performance of Point-of-Care Nucleic Acid Testing Manufacturers
- Issue Brief: Doing more, faster: Results from the routine use of innovative point-of-care technologies for early infant diagnosis in eight sub-Saharan African countries
- Issue Brief: Catalyzing Expanded Access to Early Testing, Care, and Treatment for HIV-exposed Infants in Kenya
- IAS 2017 Media Note: Promising Results from the Use of Innovative Point-of-care Early Infant Diagnosis of HIV
- ICASA 2017 Media Note: Routine use of Point-of-care Early Infant Diagnosis of HIV: Promising results
- Journal Article: Clinical effect and cost-effectiveness of incorporation of point-of-care assays into early infant HIV diagnosis programmes in Zimbabwe
A modelling study
- Integrating New Point-of-Care Technologies into National Early Infant Diagnostic Network
- Early Infant Diagnosis in Lesotho: Bringing the Test to the Baby
- Point-of-Care Early Infant Diagnosis of HIV: Moving from Successful Field Evaluations to Routine Use
- Lancet Global Health Blog: Using innovative technology to optimise early testing, care, and treatment for HIV-exposed infants
- Point-of-Care HIV Diagnostics: A ‘Game Changer’ for Saving the Lives of HIV-Exposed Infants
- Ending Pediatric AIDS: The Role of Innovative Diagnostics and Child-friendly Treatments
- African Society for Laboratory Medicine Conference (ASLM) 2016 (December 3-8, 2016)
- International AIDS Conference (IAS) 2016 (July 18-22, 2016)
- The 18th ICASA Conference on AIDS and STIs in Africa (November 29-December 4, 2015)
- International AIDS Conference (IAS) 2017 (July 23-26, 2017)
- International AIDS Conference (IAS) 2018 (July 23-27, 2018)