Utilization of digital tools to enhance COVID-19 and tuberculosis testing and linkage to care: A cross-sectional evaluation study among Bodaboda motorbike riders in the Nairobi Metropolis, Kenya.

Kenya has registered over 300,000 cases of COVID-19 and is a high-burden tuberculosis country. Tuberculosis diagnosis was significantly disrupted by the pandemic. Access to timely diagnosis, which is key to effective management of tuberculosis and COVID-19, can be expanded and made more efficient through integrated screening. Decentralized testing at community level further increases access, especially for underserved populations, and requires robust systems for data and process management. This study delivered integrated COVID-19 and tuberculosis testing to commercial motorbike (Bodaboda) riders, a population at increased risk of both diseases with limited access to services, in four counties: Nairobi, Kiambu, Machakos and Kajiado. Testing sheds were established where riders congregate, with demand creation carried out by the Bodaboda association. Integrated symptom screening for tuberculosis and COVID-19 was conducted through a digital questionnaire which automatically flagged participants who should be tested for either, or both, diseases. Rapid antigen-detecting tests (Ag-RDTs) for COVID-19 were conducted onsite, while sputum samples were collected and transported to laboratories for tuberculosis diagnosis. End-to-end patient data were captured using digital tools. 5663 participants enrolled in the study, 4946 of whom were tested for COVID-19. Ag-RDT positivity rate was 1% but fluctuated widely across counties in line with broader regional trends. Among a subset tested by PCR, positivity was greater in individuals flagged as high risk by the digital tool (8% compared with 4% overall). Of 355 participants tested for tuberculosis, 7 were positive, with the resulting prevalence rate higher than the national average. Over 40% of riders had elevated blood pressure or abnormal sugar levels. The digital tool successfully captured complete end-to-end data for 95% of all participants. This study revealed high rates of undetected disease among Bodaboda riders and demonstrated that integrated diagnosis can be delivered effectively in communities, with the support of digital tools, to maximize access.

Uptake and effectiveness of a mobile application for real-time reporting and quality assurance of decentralized SARS-CoV-2 testing in Uganda.

Background: Effective management of the COVID-19 pandemic required rapid expansion of diagnosis. The introduction of antigen tests presented an opportunity to decentralize testing, but raised challenges with ensuring accurate and timely reporting of testing data, which is essential to guide the response. Digital solutions can help address this challenge and provide more efficient means of monitoring and quality assurance. Methods: Uganda's existing laboratory investigation form was digitized in the form of an Android-based application, eLIF, which was developed by the Central Public Health Laboratory and implemented in 11 high-volume facilities between December 2021 and May 2022. The app enabled healthcare workers to report testing data via mobile phone or tablet. Uptake of the tool was monitored through a dashboard that enabled real-time visibility into data being transmitted from sites, as well as qualitative insights from site visits and online questionnaires. Results and discussion: A total of 15,351 tests were conducted at the 11 health facilities during the study period. Of these, 65% were reported through eLIF, while 12% were reported through preexisting Excel-based tools. However, 23% of tests were only captured in paper registers and not transmitted to the national database, illustrating the need for increased uptake of digital tools to ensure real-time data reporting. While data captured through eLIF were transmitted to the national database within 0-3 days (min, max), data transmitted through Excel were transmitted in within 0-37 days (min, max), and data for paper-based reporting took up to 3 months. The majority of healthcare workers interviewed in an endpoint questionnaire responded that eLIF improved timeliness of patient management, and reduced reporting time. However, some functions of the app were not successfully implemented, such as providing random selections of samples for external quality assurance and enabling seamless linkage of these data. Challenges arose from broader operational complexities, such as staff workload, frequent task-shifting and unexpected changes to facility workflows, which limited adherence to the envisioned study procedures. Ongoing improvements are needed to adjust to these realities, to strengthen the technology and support to healthcare workers using it, to optimize the impact of this digital intervention.

iCHECK-DH: Guidelines and Checklist for the Reporting on Digital Health Implementations.

BACKGROUND: Implementation of digital health technologies has grown rapidly, but many remain limited to pilot studies due to challenges, such as a lack of evidence or barriers to implementation. Overcoming these challenges requires learning from previous implementations and systematically documenting implementation processes to better understand the real-world impact of a technology and identify effective strategies for future implementation. OBJECTIVE: A group of global experts, facilitated by the Geneva Digital Health Hub, developed the Guidelines and Checklist for the Reporting on Digital Health Implementations (iCHECK-DH, pronounced "I checked") to improve the completeness of reporting on digital health implementations. METHODS: A guideline development group was convened to define key considerations and criteria for reporting on digital health implementations. To ensure the practicality and effectiveness of the checklist, it was pilot-tested by applying it to several real-world digital health implementations, and adjustments were made based on the feedback received. The guiding principle for the development of iCHECK-DH was to identify the minimum set of information needed to comprehensively define a digital health implementation, to support the identification of key factors for success and failure, and to enable others to replicate it in different settings. RESULTS: The result was a 20-item checklist with detailed explanations and examples in this paper. The authors anticipate that widespread adoption will standardize the quality of reporting and, indirectly, improve implementation standards and best practices. CONCLUSIONS: Guidelines for reporting on digital health implementations are important to ensure the accuracy, completeness, and consistency of reported information. This allows for meaningful comparison and evaluation of results, transparency, and accountability and informs stakeholder decision-making. i-CHECK-DH facilitates standardization of the way information is collected and reported, improving systematic documentation and knowledge transfer that can lead to the development of more effective digital health interventions and better health outcomes.

Correction: iCHECK-DH: Guidelines and Checklist for the Reporting on Digital Health Implementations.

[This corrects the article DOI: 10.2196/46694.].

Target product profile for readers of rapid diagnostic tests.

While equipment-free visual interpretation is a benefit of lateral-flow assays, automating the reading of rapid diagnostic tests promotes proper test performance, interpretation and reporting of the results. We have created a target product profile that describes the minimal and optimal characteristics of various rapid diagnostic test readers. The product profile is intended to promote the development of effective, useful, sustainable rapid diagnostic test readers in support of health programmes worldwide. These readers may be custom hardware or software-only running on a general-purpose mobile device, for professional or lay use, and for medical or non-medical purposes. During the development of the product profile, the World Health Organization and FIND convened a development group of 40 leading scientists, experts, public health officials and regulators. We held a public consultation to which 27 individuals or organizations responded. The product profile calls for rapid diagnostic test readers that at minimum should: (i) interpret colorimetric tests with at least 95% agreement with expert visual interpretation; and (ii) automatically report results and associated data for the health programme. Optimally, readers should: (i) provide at least 98% agreement; (ii) operate with multiple models of rapid diagnostic tests; (iii) assist the user in performing each rapid diagnostic test according to the test instructions; and (iv) offer multiple configurations, operating modes and languages to suit the needs of diverse users, settings and health programmes.

Bien que les tests à flux latéral possèdent l'avantage d'une interprétation visuelle sans nécessiter de matériel, automatiser la lecture des tests de diagnostic rapide favorise la bonne réalisation du test, mais aussi l'interprétation et la communication des résultats. Nous avons donc créé un profil de produit cible qui détaille les caractéristiques minimales et optimales de plusieurs lecteurs de tests de diagnostic rapide. Ce profil de produit vise à promouvoir le développement de lecteurs de tests de diagnostic rapide efficaces, utiles et durables, à même de contribuer aux programmes de santé à travers le monde. Il peut s'agir d'un dispositif logiciel ou matériel sur mesure, fonctionnant sur un appareil mobile ordinaire, à usage professionnel ou non professionnel, et à des fins médicales ou non médicales. Lors de la mise au point du profil de produit, l'Organisation mondiale de la Santé et la Fondation FIND ont réuni un groupe de développement composé de 40 éminents scientifiques, experts, régulateurs et responsables de la santé publique. Nous avons lancé une consultation publique, à laquelle 27 individus ou organisations ont donné suite. D'après le profil de produit, les lecteurs de tests de diagnostic rapide doivent au minimum: (i) interpréter les tests colorimétriques présentant au moins 95% de concordance avec l'interprétation visuelle des experts et (ii) communiquer automatiquement les résultats et les données associées au programme de santé. Idéalement, ces lecteurs doivent: (i) offrir un taux de concordance égal ou supérieur à 98%, (ii) être compatibles avec plusieurs modèles de tests de diagnostic rapide, (iii) aider l'utilisateur à mener chaque test de diagnostic rapide conformément aux instructions et enfin, (iv) proposer de multiples configurations, modes opératoires et langues afin de répondre aux besoins d'un large spectre d'utilisateurs, de lieux et de programmes de santé.

Mientras que la interpretación visual sin equipos es una ventaja de las pruebas inmunocromatográficas de flujo lateral, la automatización de la medición de las pruebas de diagnóstico rápido favorece la correcta realización, interpretación y comunicación de los resultados. Hemos creado un perfil de productos objetivo que describe las características mínimas y óptimas de diversos evaluadores de pruebas de diagnóstico rápido. El objetivo del perfil de producto es promover el desarrollo de evaluadores de pruebas de diagnóstico rápido eficaces, útiles y sostenibles en apoyo de los programas sanitarios de todo el mundo. Estos evaluadores pueden ser de equipo o de programas informáticos personalizados que funcionen en un dispositivo móvil de uso general, para uso profesional o no profesional, y con fines médicos o no médicos. Durante la elaboración del perfil de producto, la Organización Mundial de la Salud y FIND convocaron a un grupo de desarrollo integrado por 40 prestigiosos científicos, expertos, funcionarios de salud pública y reguladores. Celebramos una consulta pública a la que respondieron 27 personas u organizaciones. El perfil de producto exige evaluadores de pruebas de diagnóstico rápido que, como mínimo, deben: (i) interpretar las pruebas colorimétricas con una concordancia de al menos el 95% con la interpretación visual de expertos e (ii) informar automáticamente los resultados y los datos asociados para el programa sanitario. De manera óptima, los evaluadores deberían: (i) proporcionar una concordancia de al menos el 98%, (ii) funcionar con múltiples modelos de pruebas de diagnóstico rápido, (iii) ayudar al usuario a realizar cada prueba de diagnóstico rápido según las instrucciones de la prueba, y (iv) ofrecer múltiples configuraciones, modos de funcionamiento e idiomas para adaptarse a las necesidades de diversos usuarios, entornos y programas sanitarios.

Monitored Implementation of COVID-19 Rapid Antigen Screening at Taxi Ranks in Johannesburg, South Africa.

Digital tools can support community-based decentralized testing initiatives to broaden access to COVID-19 diagnosis, especially in high-transmission settings. This operational study investigated the use of antigen-detecting rapid diagnostic tests (Ag-RDTs) for COVID-19 combined with an end-to-end digital health solution, in three taxi ranks in Johannesburg, South Africa. Members of the public were eligible if they were aged ≥18 years, could read, and had a cellphone. Over 15,000 participants, enrolled between June and September 2021, were screened for COVID-19 risk factors. A digital risk questionnaire identified 2061 (13%) participants as moderate risk and 2987 (19%) as high risk, based on symptoms and/or recent exposure to a known case. Of this group referred for testing, 3997 (79%) received Ag-RDTs, with positivity rates of 5.1% in the "high-risk" group and 0.8% in the "moderate-risk" group. A subset of 569 randomly selected participants received additional PCR testing. Sensitivity of the Ag-RDT in this setting was 40% (95% CI: 30.3%, 50.3%); most false negatives had high cycle threshold values (>25), hence low viral loads. Over 80% of participants who tested positive completed a 2-week phone-based follow-up questionnaire. Overall, the digital tool combined with Ag-RDTs enhanced community-based decentralized COVID-19 testing service delivery, reporting and follow-up.

Field sales force model to increase adoption of a novel tuberculosis diagnostic test among private providers: evidence from India.

BACKGROUND: Impact of novel high-quality tuberculosis (TB) tests such as Xpert MTB/RIF has been limited due to low uptake among private providers in high-burden countries including India. Our objective was to assess the impact of a demand generation intervention comprising field sales force on the uptake of high-quality TB tests by providers and its financial sustainability for private labs in the long run. METHODS: We implemented a demand generation intervention across five Indian cities between October 2014 and June 2016 and compared the change in the quantity of Xpert cartridges ordered by labs in these cities from before (February 2013-September 2014) to after intervention (October 2014-December 2015) to corresponding change in labs in comparable non-intervention cities. We embedded this difference-in-differences estimate within a financial model to calculate the internal rate of return (IRR) if the labs were to invest in an Xpert machine with or without the demand generation intervention. RESULTS: The intervention resulted in an estimated 60 additional Xpert cartridges ordered per lab-month in the intervention group, which yielded an estimated increase of 11 500 tests over the post-intervention period, at an additional cost of US$13.3-US$17.63 per test. Further, we found that investing in this intervention would increase the IRR from 4.8% to 5.5% for hospital labs but yield a negative IRR for standalone labs. CONCLUSIONS: Field sales force model can generate additional demand for Xpert at private labs, but additional strategies may be needed to ensure its financial sustainability.

Target Product Profile for a mobile app to read rapid diagnostic tests to strengthen infectious disease surveillance.

The essential role of rapid diagnostic tests (RDTs) in disease control is compromised every time a test is not performed correctly or its result is not reported accurately and promptly. A mobile app that utilizes the camera and connectivity of a common smartphone can fill this role of supporting the test's proper execution and the automatic transmission of results. In a consensus process with 51 expert participants representing the needs of clinical users, healthcare programs, health information systems, surveillance systems, and global public health stakeholders, we developed a Target Product Profile describing the minimal and optimal characteristics of such an app. We collected feedback over two rounds and refined the characteristics to arrive at a preferred agreement level of greater than 75%, with an average of 92% agreement (range: 79-100%). As per this feedback, such an app should be compatible with many RDTs and mobile devices without needing accessories. The app should assist the user with RDT-specific instructions, include checks to facilitate quality control of the testing process and suggest results with ≥ 95% accuracy across common lighting conditions while allowing the user to determine the final result. Data from the app must be under the control of the health program that operates it, and the app should support at least one of the common data exchange formats HL7, FHIR, ASTM or JSON. The Target Product Profile also lays out the minimum data security and privacy requirements for the app.

Initiative for Promoting Affordable and Quality Tuberculosis Tests (IPAQT): a market-shaping intervention in India.

A majority of patients with tuberculosis (TB) in India are diagnosed and treated in the private sector. Yet, most private providers do not use most recent WHO-endorsed microbiological tests such as liquid cultures, line probe assays and Xpert MTB/RIF due to a combination of factors such as lack of awareness, misaligned incentives and high prices that are unaffordable for patients. We designed a market-based approach to transform a high-price, low-volume market equilibrium into a low-price, high-volume equilibrium to improve the uptake of these tests. Toward this end, a non-profit consortium of private laboratories, called Initiative for Promoting Affordable and Quality Tuberculosis Tests (IPAQT) was formed in India in March 2013. It negotiated lower pricing on equipment and reagents with manufacturers, closer to that offered to the public sector. In return, IPAQT assured that this discount was passed on to patients, who typically paid for these tests out of their pockets, through an informally agreed on retail ceiling price. IPAQT also invested in demand generation activities that complemented the supply-side effort. IPAQT membership grew from 56 laboratories in 2013 to 211 in 2018. During this period, the initiative resulted in a 10-fold increase in the uptake of Xpert and a 30%-50% reduction in price. This initiative is planned to be expanded to other South Asian countries with similar TB epidemic and private market structure and dynamics. However, long-term sustainability of the initiative would require developing more cost-effective marketing activities and integration with broader private sector engagement agenda of the national TB programme.