Accelerating Access to Innovative Point-of-Care HIV Diagnostics

This document was developed to compile knowledge, insights and recommendations from UNICEF focal points in country offices implementing a project aimed at introducing, scaling up, and integrating point-of-care (POC) diagnostics into national health systems.The project was implemented by UNICEF, CHAI and ASLM with funding from Unitaid in 10 sub-Saharan African countries between 2016-2020. As the project was winding down, we thought it was important to document the lessons learned from those with direct, hands-on experience in project implementation to offer guidance to other countries interested in adopting POC technologies to increase access to diagnostics.

Innovative POC diagnostics can be a game changer in health systems as it enables testing outside the laboratory and closer to patients, can be used for the diagnosis of multiple diseases, addresses key limitations of conventional laboratory networks, and significantly increases access to diagnostic testing in a decentralized fashion. Decentralization of testing also carries an additional benefit as it strengthens elements of the health system around diagnostics (e.g., supply chain management, quality management, connectivity and data management, waste management) that have a broader impact on the health system. The multi-disease testing capacity of POC devices also contributes to pandemic preparedness and response, as has been shown by its use in the Ebola outbreak in West Africa (2014-2016) as well as its widespread use during the COVID-19 pandemic.

The impact of POC diagnostic technologies cannot be overstated. This is particularly important in communities in low-resource settings with limited access to diagnostics as well as patients whose clinical management depends upon quick diagnostic test results – such as children infected with HIV. Without treatment, up to 50 per cent of children living with HIV die by their second birthday, with a peak mortality between two and three months of age. Thus, HIV-exposed infants need to be diagnosed before two months of age using molecular diagnostic methods until recently only available in conventional laboratories. However, such conventional laboratory systems carry inherent limitations that restrict their ability to provide timely results in various settings, particularly low-resource settings. It was this urgent need to diagnose HIV-positive infants and initiate them on treatment as soon as possible that motivated this project. POC diagnostics introduction and scale up allowed faster diagnosis, which in turn increased the number of HIV-infected children diagnosed and initiated on treatment within two months of age.

Although the project was focused on increasing access to early infant diagnosis of HIV through POC testing, it also demonstrated the cost-effectiveness of POC diagnostics and the benefits of multi-disease testing by integrating HIV viral load and TB testing on the same POC diagnostic platforms. In spite of the focus on HIV, the lessons reported here are broadly relevant for other disease programmes. These lessons are organized in seven main topics: (1) Leadership commitment and support; (2) Laboratories and the supply chain; (3) Engagement with civil society organizations(CSOs); (4) Diagnostics network optimization (DNO); (5) Innovative approaches; (6) Transition to national governments and other long-term funding partners; and (7) Grant design and management. These lessons build upon the 'Key Considerations for Introducing New HIV Point-of-Care Diagnostic Technologies in National Health Systems' published in 2017, and 'Lessons Learned from Integrating Point-of-Care testing Technologies for Early Infant Diagnosis of HIV into National Diagnostic Networks' published by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) in 2019. Together, these resources offer a comprehensive perspective on the strategies, challenges, and lessons learned in the course of integrating POC diagnostics into national health systems that countries should consider when introducing and/or scaling up POC diagnostics.

 

cover of poc lessons learned

Accelerating Access to Innovative Point-of-Care HIV Diagnostics

English - French

Nurturing care for children affected by HIV

In the early years, we lay down critical elements for health, well-being and productivity, which last throughout childhood, adolescence and adulthood. Failure to meet a child’s needs during this critical period limits the child’s ability to achieve their full developmental potential and threatens the future of human capital and society in general. This is particularly so for children affected by HIV who experience several interrelated factors that may hinder the achievement of a child’s full developmental potential.

This brief from UNICEF and WHO describes the specific nurturing care components for children affected by HIV as well as facility-level and community-level actions for early childhood development.

HIV Pediatrics 2020 Workshop Report

The International Workshop on HIV & Pediatrics 2020 took place virtually on 16-17 November. It provided a global update on paediatric HIV and explored pertinent issues through dedicated plenary and oral abstract sessions on prevention of mother-to-child transmission of HIV, paediatric treatment and care, and adolescents and HIV. It also included sessions on COVID-19 in children.

UNICEF and Virology Education have developed a workshop report that summarises highlights and learnings from each session.

Presentations and webcasts (provided speaker's consent) are also publicly available and can be accessed here.

Strengthening Paediatric TB and HIV Case Finding at the Frontline: TB/HIV Integrated Community Case Management (iCCM)

Community and primary health facility platforms have been recognized as important, but under-utilized entry points to address the large prevention, case detection and treatment gaps faced by young children with TB and/or HIV. In 2014, WHO and UNICEF revised community health worker packages for integrated community case management (iCCM) targeting children under five years of age, to include screening and referral for TB and HIV (TB/HIV iCCM). As part of an integrated, child-centered approach, TB/HIV iCCM is recommended for use in high TB and HIV burden settings.

Developed by UNICEF and Save the Children, Lessons from the Field (Uganda, Nigeria, Malawi) and Guidance (under development) are available for download.

Going the 'Last Mile' to EMTCT: A road map for ending the HIV epidemic in children

The 'Last Mile' road map draws on the latest scientific research and programmatic evidence to describe and recommend strategies to achieve the elimination of mother-to-child transmission of HIV (EMTCT). It includes a synthesis of evidence and country experiences for reaching EMTCT and recommends clear strategies that can improve the coverage, effectiveness and quality of national programmes for the prevention of mother-to-child transmission (PMTCT). The goal of this document is to provide guidelines for coordinated action so that national programmes address local priority areas to achieve EMTCT in an effective, people-centred, efficient and directed manner.

This document was conceptualized by the United Nations Children’s Fund (UNICEF) and partners including the Start Free working group, the Joint United Nations Programme for HIV/AIDS (UNAIDS) and the World Health Organization (WHO), and it was validated by ministries of health of Botswana, Malawi, Seychelles, Uganda, Zambia and Zimbabwe.

Site Monitoring Guidance and Checklists

Regular monitoring of POC EID implementation sites is crucial for ensuring the quality and efficacy of site-level operations throughout the project. Site monitoring visits will provide essential insights into site-level issues related to human resources, patient flow, platform functioning, end user performance, specimen transport, data, data quality, and capacity building needs of site level staff.

Author: EGPAF

Year: 2017

Post-Market Surveillance

Post-market surveillance aims to ensure that IVDs continue to meet the same quality, safety and performance requirements as when they were initially placed on the market. WHO has developed normative guidance on post-market surveillance of in vitro diagnostics, emphasizing the importance of both reactive post-market surveillance and proactive post-market surveillance activities.

Reactive post-market surveillance refers to activities undertaken after an issue has occurred related to the IVD test (e.g., complaint reporting/monitoring; end user quality control programs, etc.), whereas proactive post-market surveillance refers to scans for potential issues related to the IVD (e.g., pre- and/or post-distribution lot testing). Lot testing involves testing samples from a manufacturing lot to ensure performance meets an acceptable standard.

For additional information on post-market surveillance, including sample reporting forms, see http://www.who.int/diagnostics_laboratory/postmarket/en/