Real-Life Implementation Of A G6pd Deficiency Screening Qualitative Test Into Routine Vivax Malaria Diagnostic Units In The Brazilian Amazon (Safeprim Study)

Background Glucose-6-phosphate dehydrogenase (G6PD) deficiency greatly hinders Plasmodium vivax malaria radical cure and further elimination due to 8-aminoquinolines-associated hemolysis. Although the deleterious health effects of primaquine in G6PD deficient individuals have been known for over 50 years, G6PD testing is not routinely performed before primaquine treatment in most P. vivax endemic areas.Method/Principal findings The qualitative CareStart G6PD screening test was implemented in 12 malaria treatment units (MTUs) in the municipality of Rio Preto da Eva, Western Brazilian Amazon, a malaria endemic area, between February 2019 and early January 2020. Training materials were developed and validated; evaluations were conducted on the effectiveness of training health care professionals (HCPs) to perform the test, the interpretation and reliability of routine testing performed by HCPs, and perceptions of HCPs and patients. Most HCPs were unaware of G6PD deficiency and primaquine-related adverse effects. Most of 110 HCPs trained (86/110, 78%) were able to correctly perform the G6PD test after a single 4-hour training session. The test performed by HCPs during implementation showed 100.0% (4/4) sensitivity and 68.1% (62/91) specificity in identifying G6PD deficient patients as compared to a point-of-care quantitative test (Standard G6PD).Conclusions/Significance G6PD screening using the qualitative CareStart G6PD test performed by HCPs in MTUs of an endemic area showed high sensitivity and concerning low specificity. The amount of false G6PD deficiency detected led to substantial loss of opportunities for radical cure.Author summary Glucose 6-phosphate dehydrogenase deficiency (G6PDd) has greatly impacted the treatment of Plasmodium vivax malaria because of the red blood cell destruction in what is known as hemolysis. Primaquine, used to clear dormant liver parasites that cause relapses of the disease, is a well-known trigger that may lead to life-threatening complications in patients with this condition. Although there are several G6PDd diagnostic tests available to guide the decision of weekly or daily primaquine treatment, they are not yet routinely used: questions on how, when, where and who is going to perform the test remain unanswered. This study revealed that, although G6PDd was not previously known by most of the healthcare workers, they were able to perform the test after a single training session. The test performed well in the field, differentiating patients that cannot use daily primaquine from the others, but some expected limitations require further action to be taken into consideration. This research provides an important overall understanding that may aid policy makers in the process of recommending proven interventions, such as G6PDd screening, to implement them pragmatically.