Viral load monitoring

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.

 

Accelerating Access to Innovative Point-of-Care HIV Diagnostics

English - French

In 2019 it was estimated that 1.2 million children (0-14) were living with HIV in Eastern and Southern Africa, yet more than a half million of these children (504,000) were not receiving lifesaving treatment. Children with HIV need to achieve viral load suppression if they are to lead long and healthy lives. Population-based surveys in Malawi, Uganda and Zimbabwe found that children on treatment fare worse in achieving viral load suppression compared to adults; 42 per cent vs 67 per cent, 39 per cent vs 84 per cent and 47 per cent vs 86 per cent respectively. Ending AIDS will not be possible without accelerating progress for children.

UNICEF, in collaboration with governments and partners, supported a mixed method study that included literature review, assessment of laboratory data in Malawi, Uganda and Zimbabwe and interviews with health workers and caregivers in Malawi to find out what is behind these low rates. The study found that one out of every three children who had a viral load test had not achieved viral load suppression. Support networks for caregivers and children improved adherence and made a difference towards outcome. The full report describes the methodology, key findings, challenges and proposes concrete recommendations to improve treatment outcomes for children with HIV. The accompanying advocacy brief summarizes the key findings and provides action-oriented next steps

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.

This brief summarizes lessons learned from Zimbabwe’s pilot implementation of integrated or multi-disease testing. Partnerships in the country focused on leveraging existing GeneXpert platforms for both TB and HIV testing to improve access to early infant HIV diagnosis and viral load testing. These findings describe the benefits of integrated testing for clients, health providers and the health system and are a resource for other countries scaling up point-of-care integrated testing.

The strategic plan focuses on preventing new HIV infections in order to maintain a low HIV prevalence in the next six years. The NSP aims to reduce new HIV infections by 50% by 2020; intensify the provision of quality and accessible HIV prevention information and services for key populations; and also accelerate actions to eliminate mother-to-child transmission of HIV by 2020, including placing positive mothers on lifelong antiretroviral therapy (Option B+) as the preferred regime of treatment for HIV positive pregnant women.

Appel pour l’accélération de l’élimination de la transmission mère-enfant du VIH et le traitement antirétroviral chez l’enfant en Afrique de l’ouest et du centre d’ici 2020

Call for the acceleration of the elimination of mother-to-child HIV transmission and antiretroviral treatment for children in West and Central Africa by 2020

In June 2016, ICAP and partners convened a three-day, PEPFAR-supported meeting to explore the practical challenges of scaling up routine viral load testing in sub-Saharan Africa. The meeting took place in Ezulwini, Swaziland and brought together over 150 public health experts from 15 countries. This meeting report provides a comprehensive summary of the convening.