As newly developed G6PD diagnostics advanced toward commercialization and adoption in malaria-endemic regions, PATH recognized the need for programs, researchers, manufacturers, and institutions across the world to collaborate, share findings, and research methods.
Market Research & Commercialization
The unique biology of the Plasmodium vivax (P. vivax) parasite makes it the most challenging type of malaria to cure. The parasite hides in the liver and can cause illness—and infectivity—long after the first infection. Up to 2.8 billion people are at risk of disease. But it is not as simple as diagnosing P. vivax and administering the cure. Patients deficient in the glucose-6-phosphate dehydrogenase (G6PD) enzyme are at risk of severe anemia when treated with 8-aminoquinoline drugs (primaquine and newly introduced tafenoquine) used to kill the malaria parasites that lie dormant in the liver. This is known as a “radical cure.” As a result, the World Health Organization recommends conducting a G6PD test before initiating radical cure treatment. A simple point-of-care test for G6PD deficiency would enable wide-scale radical cure treatment of patients with P. vivax malaria and accelerate the elimination of the disease. However, essential tools for point-of-care G6PD testing were not available until recently.
Changing diagnostic and treatment algorithms and ensuring that health care providers can readily adhere to changing guidance is often challenging. Many years of conducting useability studies for diagnostic products with end users in malaria control and elimination settings have highlighted the need for robust user research to identify, and address, the challenges inherent in integrating new tests into routine care. When PATH began supporting the development of point-of-care G6PD diagnostic tests to be sustainably integrated into malaria case management, consideration of use case scenarios, training requirements, and user pain points was an integral part of PATH’s work.
As newly developed G6PD diagnostics advanced toward commercialization and adoption in malaria-endemic regions, PATH recognized the potential for programs, researchers, manufacturers, and institutions across the world to collaborate, share findings, and research methods. A robust operations research collaboration would help to build consensus and partnerships to ensure new tests were implemented based on best practices and evidence. This soon evolved into a “community of practice,” a global collaboration of scientists, researchers, and end users to share materials, methods, and resources to support the introduction and scale-up of G6PD diagnostics.
The G6PD Operations Research Community of Practice (GORCoP) evolved as a means of convening a global network of researchers, organizations, malaria control programs, and clinicians to share user research and findings on the introduction and scale up of G6PD diagnostics. First convened in 2019, the GORCoP aimed to build consensus and partnerships to ensure that new tests were implemented based on best practices and evidence by amplifying participants’ expertise in diagnostic introduction, operations research, implementation science, quality assurance, and training.
The GORCoP invites members to share their experiences via quarterly live webinar presentations on the latest developments on G6PD operational research. With over 13 archived presentations to date highlighting lessons learned during training, research, and implementation and sharing best practices related to ethics and quality assurance for point-of-care testing, the GORCoP has supported the advancement of G6PD diagnostics by aligning and amplifying important implementation evidence.
Popular presentations on local and global health introduction and scale-up challenges have included webinars sharing early experiences with G6PD point-of-care testing in malaria-endemic regions, interpreting quantitative tests, training health care workers in the Amazon, communicating results and counseling, and sharing tools for cost-effectiveness of radical cure options. The GORCoP also maintains a digital library of G6PD diagnostics training and quality assurance resources that include sample protocols, training, quality assurance, and patient education materials to support further collaboration and information sharing between national malaria control programs, researchers, and institutions working to advance the use of G6PD tests at the point of care.
The impact of using human-centered design
Since its inception in 2019, the GORCoP has become a successful platform for sharing best practices and user research findings in support of the rapid adoption of G6PD diagnostics. It has accelerated the adoption of a radical cure for P. vivax malaria by:
- Providing a platform to encourage collaboration between national malaria control programs, researchers, and institutions working to advance the use of G6PD tests at the point of care.
- Harmonizing the outcomes of operations research studies by sharing flexible and adaptable research plans with prioritized research questions, potential methods, and measures and indicators of success.
- Allowing for the co-creation and dissemination of resources and tools, such as training materials, patient education materials, and sample protocols to facilitate G6PD test introduction.
Now with more than 200 members and drawing from over 100 different organizations worldwide, the GORCoP has been a valuable means of supporting the introduction and adoption of G6PD diagnostics.
“The GORCoP has been as useful as the willingness of our partners and early adopters to share experiences and lessons learned, for which we are extremely grateful.”— Gonzalo Domingo, Senior Scientific Director, PATH Diagnostics