Background In sub-Saharan Africa, the material and human capacity to diagnose patients reporting with fever to healthcare providers is largely insufficient. Febrile patients are typically treated presumptively with antimalarials and/or antibiotics. Such over-prescription can lead to drug resistance and involves unnecessary costs to the health system. International funding for malaria is currently not sufficient to control malaria. Transition to domestic funding is challenged by UHC efforts and recent COVID-19 outbreak. Herewith we present a digital approach to improve efficiencies in diagnosis and treatment of malaria in endemic Kisumu, Kenya: Connected Diagnostics. The objective of this study is to evaluate the feasibility, user experience and clinical performance of this approach in Kisumu. Methods Our intervention was performed Oct 2017–Dec 2018 across five private providers in Kisumu. Patients were enrolled on M-TIBA platform, diagnostic test results digitized, and only positive patients were digitally entitled to malaria treatment. Data on socio-demographics, healthcare transactions and medical outcomes were analysed using standard descriptive quantitative statistics. Provider perspectives were gathered by 19 semi-structured interviews. Results In total 11,689 febrile patients were digitally tested through five private providers. Malaria positivity ranged from 7.4 to 30.2% between providers, significantly more amongst the poor (p < 0.05). Prescription of antimalarials was substantially aberrant from National Guidelines, with 28% over-prescription (4.6–63.3% per provider) and prescription of branded versus generic antimalarials differing amongst facilities and correlating with the socioeconomic status of clients. Challenges were encountered transitioning from microscopy to RDT. Conclusion We provide full proof-of-concept of innovative Connected Diagnostics to use digitized malaria diagnostics to earmark digital entitlements for correct malaria treatment of patients. This approach has large cost-saving and quality improvement potential.

Background Low- and middle-income countries (LMICs) are increasingly adopting low-cost Coronavirus disease 2019 (COVID-19) rapid antigen tests to meet the high demand for SARS-CoV-2 testing. Whilst testing using real-time polymerase chain reaction (RT-PCR) is the current gold standard, its widespread use in LMICs is limited by high costs, turnaround times and is not readily available in most places. COVID-19 antigen tests (Ag-RDT) provide a suitable alternative due to their low cost, rapid turnaround time and easy to set up and use. This study aimed to assess the field performance of the NowCheck COVID-19 antigen kit (Ag-RDT) as a point of care test (POCT) in select healthcare facilities in western Kenya. Methods We conducted a prospective multi-facility field evaluation study of the NowCheck COVID-19 rapid antigen test (Ag-RDT) compared to SARS-CoV-2 RT-PCR (RT-PCR). After obtaining informed consent, trained laboratory technicians collected two pairs of oropharyngeal and nasopharyngeal swabs, both antigen and RT-PCR testing, first for Ag-RDT and next for RT-PCR. We performed Ag-RDTs on-site and shared the results with both the study participants and their healthcare providers within 15-30 minutes. We carried out all RT-PCR tests in a central referral laboratory. The turnaround time for RT-PCR results was typically 24-48 hours. We captured the results of both methods using an electronic digital application. Findings Between December 2020 and March 2021, we enrolled 997 participants who met the Kenyan Ministry of Health COVID-19 case definition. The median age of study participants was 39 years (range one to 80 years), with 54% male. Ag-RDT had a sensitivity of 84.5% (76.0-90.8) and a specificity of 94.4% (95% CI: 92.7-95.8) with an accuracy of 94.2% (92.5- 95.6) when a cycle threshold value (Ct value) of ≤35 was used. The highest sensitivity of 87.7% (77.2-94.5) was observed in samples with Ct values ≤ 30 and the highest specificity of 97.5% (96.2-98.5) at Ct value of <40. Interpretation The NowCheck COVID-19 Ag-RDT showed good performance in field evaluation in multiple healthcare facilities in a developing country. The sensitivity of the kit exceeded the minimum recommended cut-off of 80% as recommended by WHO1. The high specificity of this kit at 94.4% at Ct values ≤33 and 97.5% at Ct values <40 matched that of real-time PCR, making it a good rule-out test for symptomatic patients with COVID-19- like symptoms. The faster turnaround time to results, lower cost, simple analytical steps requiring no equipment or infrastructure makes antigen testing an attractive field-screening method to meet the high demand for COVID-19 testing.

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In low-and middle-income countries, achieving universal health coverage remains challenging due to insufficient, temporary and fragmented funding as well as limited accessibility to quality healthcare. Leveraging a mobile health platform can be a powerful tool to address these problems. This paper demonstrates how analysing data collected from a mobile health platform helps optimize healthcare provider networks, monitor patient flows and assess the quality and equitability of access to care. The COVID-19 pandemic reinforces the importance of real-time data on health-seeking behaviour. Between 2018 and 2019, as a Kenyan universal health coverage pilot was being planned, Kisumu County, with support from PharmAccess Foundation, implemented household-level digital registration for healthcare and collected socio-economic and healthcare claims data using the M-TIBA platform. In total, 273,350 Kisumu households enrolled. The claims data showed many patients visit higher-level facilities for ailments, that can be treated at primary care levels, unnecessarily. High-level estimate of the disease burden at participating facilities revealed rampant overprescription of pertinent medicines for highly prevalent malaria and respiratory tract infections, exemplifying clinical management deficiencies. M-TIBA data allowed tracking of individual patient trajectories. Analyses of data are shown at the aggregate level. The paper shows how mobile health platforms can be used to generate valuable insights into access to and quality of care. Funding for healthcare can be united through mobile health platforms, limiting the fragmentation in funding. They can be useful for funders, health managers and policymakers to improve the implementation of universal health coverage programs in low-and middle-income countries.

Abstract Background: In sub-Saharan Africa, the material and human capacity to diagnose patients reporting with fever to healthcare providers is largely insufficient. Febrile patients are typically treated presumptively with antimalarials and/or antibiotics. Such over-prescription can lead to drug resistance and involves unnecessary costs to the health system. International funding for malaria is decreasing and transition to domestic funding is challenged by UHC efforts and recent COVID-19 outbreak. Herewith we present a digital approach to markedly improve efficiencies in diagnosis and treatment of malaria in endemic Kisumu, Kenya. The objective of this study is to evaluate feasibility, user experience, clinical performance and of Connected Diagnostics in Kisumu and to assess over-prescription of antimalarials. Methods: Our intervention was performed Oct 2017 – Dec 2018 across seven providers in Kisumu. Patients were enrolled on M-TIBA platform, diagnostic test results digitized, and only positive patients were digitally entitled for malaria treatment. Data on socio-demographics, healthcare transactions and medical outcomes were analysed using standard descriptive quantitative statistics. Provider perspectives were gathered by 19 semi-structured interviews. Results: In total 11,689 febrile patients were tested. Malaria positivity rates ranged from 7.4% to 30.2% between providers, with significantly more positive cases amongst the poor (p< 0.05). Over-prescription of antimalarials was 28%, fluctuating between 4.6% to 63.3% per provider. Prescription of branded versus generic antimalarials was dichotomous. Challenges were encountered transitioning from microscopy to RDT. Conclusion: We provide full proof-of-concept of innovative Connected Diagnostics to use digitized malaria diagnostics to earmark digital entitlements for correct malaria treatment of patients. This approach has large cost-saving and quality improving potential.