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A.A. Onasanya

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Outcome of a preliminary quasi-experimental study for microfilaria detection using a novel diagnostic device in Nigeria

Journal article (2024) - Adeola Onasanya, Temitope Agbana, Opeyemi Oladunni, Jo Van Engelen, Oladimeji Oladepo, Jan Carel Diehl
Background: Lymphatic filariasis (LF) is a Neglected Tropical Disease (NTD) with high morbidity. Tools for detecting LF are either not readily available or used by Community Health Extension Workers (CHEWs) at Primary Health Centers. A newly developed diagnostic device, the AiDx Assist, is targeted for use by CHEWs.

Objective: The study aims to determine the efficiency (speed) and effectiveness (diagnostic capacity) of CHEWs compared to laboratory scientists for detecting LF with the new device, using the World Health Organization’s Target Product Profile (TPP) for LF diagnostics as a guide.

Methods: This study utilized a Quasi-experimental design. 7 students undergoing the CHEW program (intervention group) were randomly selected while 2 laboratory scientists (control group) were purposively recruited and were trained to use the device. Thereafter, both groups were tested based on 64 sample slides provided.

Results: The intervention group’s efficiency (speed) was similar to the control group. Computed Effectiveness (diagnostic capacity ) parameters for the intervention group demonstrated a sensitivity of 85.7% and a specificity of 82.5%.

Conclusion: Given this preliminary result, task shifting to CHEWs for the diagnosis of LF is highly likely to be successful, thereby reducing the prevalence of LF in low-resource settings. ...

User Experience of a New Digital Diagnostic Device in Low-Income Settings

Journal article (2023) - A.A. Onasanya, Michel Bengtson, T.E. Agbana, Opeyemi Oladunni, J.M.L. van Engelen, Oladimeji Oladepo, J.C. Diehl
Designing new and inclusive diagnostic tools to detect Neglected Tropical Diseases (NTDs) to achieve rational disease control requires a co-design process where end-users’ input is important. Failure to involve all potential end-users in new diagnostics for NTDs can result in low use and adoption failure, leading to persistent infection hot spots and ineffective disease control. There are different categories of potential end-users of new diagnostic tools for NTD control, and it is unclear if there are differences between the user efficiency, effectiveness, perception, and acceptability across these end-user categories. This study evaluated the usability, user perception, contextual factors affecting the user’s experience, and acceptability of a new digital optical diagnostic device for NTDs across three types of potential end users. A total of 21 participants were tested. Laboratory scientists, technicians, and Community Health Extension Workers (CHEWs) in training achieved similar scores on the usability and user perception questionnaires with no statistically significant difference between end-user categories. All participants also have high scores for the user perception domains which strongly correlate with the acceptability of the AiDx NTDx Assist device. This study indicates that, by providing digital diagnostic tools in combination with minimal training and support, CHEWs undergoing training and, by extension, CHEWs post-training, can be involved in the diagnoses of NTDs, potentially enhancing a community’s capabilities to diagnose, treat, and control NTDs. ...
Doctoral thesis (2023) - A.A. Onasanya, J.C. Diehl, J.M.L. van Engelen, A.A. Oladepo
Neglected Tropical Diseases (NTDs) affect more than two billion people worldwide and cause significant morbidity and mortality. Despite their impact, these diseases receive limited attention in the development of diagnostics, medicines, and vaccines. For many parasitic NTDs, microscopy remains the primary diagnostic tool, yet it is often unavailable or requires expertise that is lacking in primary healthcare settings. Digital optical diagnostics could provide affordable, user-friendly alternatives that support diagnosis, treatment, and monitoring. However, designing such devices requires a strong understanding of the social and healthcare context in which they will be used, as well as close collaboration with stakeholders. The main objective of this thesis is to investigate how smart optical diagnostics for NTDs can be developed for endemic countries by integrating local knowledge and experience to support local adoption.

The thesis shows that the use context of digital diagnostics is complex and involves interactions between physical, social, cultural, and organizational factors. Healthcare policies, workflows, resources, and users all shape how a diagnostic device can be used. Social factors influence awareness of diseases, interest in prevention and treatment, and the availability, accessibility, affordability, and acceptability of diagnostic resources. Collaboration among stakeholders—including healthcare workers, communities, policymakers, and organizations—is therefore essential for successful device design and implementation.

To support this, the thesis presents a five-step iterative design process consisting of empathizing, defining, ideating, prototyping, and testing. Co-creation with stakeholders plays a central role throughout this process, helping to build shared understanding of disease challenges and opportunities for innovation. Methods such as stakeholder mapping, social network analysis, document reviews, interviews, and Q-methodology can be used to identify and involve relevant stakeholders in the design process.

The diagnostic device design itself also requires iterative collaboration. Five key design components are identified: the overall device concept and evaluation, the software system, the hardware system, the structural composition and style of the device, and the product documentation. Through this process, two categories of product specifications emerge: broad-based and context-based specifications. Broad-based specifications include technical, regulatory, and business requirements. Technical specifications cover manufacturing aspects and performance requirements such as sensitivity, specificity, and speed. Regulatory specifications involve compliance with standards from organizations such as ISO and WHO, while business specifications address financing and cost considerations. Context-based specifications relate to factors affecting usability, user experience, and acceptability within the local healthcare setting.

The interaction between these specifications leads to different product use scenarios for NTD diagnostics. In the Nigerian context, three potential scenarios are identified: screening programs, monitoring and evaluation of interventions, and point-of-care testing.

Finally, the thesis highlights that adopting new NTD diagnostics is a complex, multi-stage process involving research, training, implementation, monitoring, maintenance, and scale-up. Adoption can be hindered by limited resources, infrastructure gaps, political instability, and cultural differences. Successful implementation therefore requires early needs assessment, stakeholder involvement, regulatory alignment, training of healthcare workers, and continuous monitoring.

Overall, the thesis demonstrates that developing and implementing digital diagnostics for NTDs requires a systemic design approach that integrates context, stakeholder collaboration, and technological development to ensure that new diagnostic tools are usable, acceptable, and effective in endemic settings. ...
Journal article (2023) - Adeola Onasanya, Jo van Engelen, Opeyemi Oladunni, Oladimeji Oladepo, Jan Carel Diehl
BACKGROUND: Schistosomiasis is one of the neglected tropical diseases targeted for elimination by 2030. Achieving disease elimination requires collaboration between stakeholders, country ownership and the involvement of community-level stakeholders. The state of stakeholder relationship determines the ease and timeliness of meeting disease elimination targets. Mapping stakeholder relationships is critical for assessing gaps in the schistosomiasis control program implementation, and providing a roadmap for improved stakeholder cohesion. The study aimed to measure the cohesiveness of the contact, collaboration and resource-sharing networks, across 2 local government areas in Oyo state, Nigeria. MATERIALS AND METHODS: This study used a Network Representative design for Social Network Analysis (SNA). The study was conducted within Oyo state, Nigeria using 2 Local Government Areas (LGAs): Ibadan North (urban) and Akinyele (rural). Stakeholders were identified using a link-tracing approach. Data was collected using Qualtrics software from stakeholders across the state, local government, healthcare, academia, and non-governmental organizations. Data was analysed using Gephi software for network cohesion across the three networks. RESULTS: The social network analysis revealed high clustering and low density across the three networks implying low cohesion across multiple stakeholder categories. The contact and collaborative networks were the most active with the lowest level of cohesion seen in the resource-sharing network. Stakeholders were more active in the rural LGA than the urban, and stakeholders within the organized governance and public health system were the dominant actors in the schistosomiasis control program. CONCLUSION: The low cohesion, high clustering and low network density among stakeholders within the schistosomiasis control program should be addressed in other to drive innovation and meet the WHO schistosomiasis elimination target. ...

A need for guidance via target product profiles

Journal article (2023) - Adeola Onasanya, Michel Bengtson, Ludo de Goeje, Jo van Engelen, Jan-Carel Diehl, Lisette van Lieshout
IntroductionThe INSPIRED project aims to develop inclusive Digital Optical Diagnostic Devices (DODDs) for schistosomiasis, to support disease management by enabling rapid diagnostic results, to improve efficient data management to guide decision-making and to provide healthcare workers with critical health information to facilitate follow-up action. Due to the non-availability of Target Product Profiles (TPPs) for guiding the development of digital diagnostics for schistosomiasis, we explored existing diagnostic TPPs.MethodsUsing a curated open access database (Notion database), we studied a selection of TPPs for diagnosing infectious diseases, focusing on specifications related to digital health products for Neglected Tropical Diseases (NTDs).ResultsEighteen TPPs originating from 12 documents, covering 13 specific diseases, were selected and their characteristics were labeled and entered into the database. Further exploration of the database revealed several gaps, including a lack of stakeholder input, sustainability, and TPP availability. Other significant gaps related to digital health platform interconnectivity and data stewardship specifically in relation to digital diagnostics, including DODDs.DiscussionThese findings reflect two possible scenarios: (1) there is currently no need for digital diagnostic devices for schistosomiasis and, by extension for other NTDs; or (2) those needs are not yet covered by TPPs. Therefore, we recommend that digital health diagnostics are included in the use cases for schistosomiasis control and elimination, at least in the ideal/desirable scenario, as this will guide research and incentivize investment in digital health diagnostics for schistosomiasis. ...
Conference paper (2022) - M.L. Bengtson, A.A. Onasanya, P.O. Oyibo, Brice Meulah, K.T. Samenjo, I.G. Braakman, Wellington Oyibo Andi, J.C. Diehl
Schistosomiasis is a neglected tropical disease thatis predominantly diagnosed by conventional microscopy in Sub-Saharan Africa. However, effective diagnosis by conventional microscopy is limited by multiple technical and logistic barriers.Alternative diagnostic techniques are needed. The Schistoscope is a digital optical device that has been designed to support microscopists for the detection of schistosomiasis in endemic resource-limited settings. Aim: A user-centered design approachwas used to assess the usability and user-acceptance of the Schistoscope compared to conventional microscopy in the Federal Capital Territory, Abuja, Nigeria. In this study, usability and acceptance are defined as being easy-to-use, efficient, and suitable in the daily workflow by end-users. Methods: Using a qualitative conventional context analysis approach, a mixedmethods questionnaire was used to elucidate themes related to the usability and user-acceptance of the device. Participants included trained microscopists and university students (n=17). Results: Participants answered both ranked and open questions. Overall the device’s use was considered to be easy and acceptable
in the routine workflow of a microscopist. The auto-scan feature was considered to have added value. Critical feedback regarding aesthetics of the device, particularly related to size, was noted by the participants. Conclusion: The usability approach used in this study elucidated valuable insights of end-users. The Schistoscope was very well perceived by both medical students and trained microscopists. Critical feedback will be used to further improve the next iterative design of the device. ...
Journal article (2022) - K.T. Samenjo, Michel Bengtson, A.A. Onasanya, Juan Carlo Intriago Zambrano, Opeyemi Oladunni, Oladimeji Oladepo, J.M.L. van Engelen, J.C. Diehl
Urinary schistosomiasis is a waterborne parasitic infection caused by Schistosoma haematobium that affects approximately 30 million people annually in Nigeria. Treatment and eradication of this infection require effective diagnostics. However, current diagnostic tests have critical shortcomings and consequently are of limited value to stakeholders throughout the health care system who are involved in targeting the diagnosis and subsequent control of schistosomiasis. New diagnostic devices that fit the local health care infrastructure and support the different stakeholder diagnostic strategies remain a critical need. This study focuses on understanding, by means of Q-methodology, the context of use and application of a new diagnostic device that is needed to effectively diagnose urinary schistosomiasis in Oyo State, Nigeria. Q-methodology is a technique that investigates subjectivity by exploring how stakeholders rank-order opinion statements about a phenomenon. In this study, 40 statements were administered to evaluate stakeholder perspectives on the context of use and application of potential new diagnostic devices and how these perspectives or viewpoints are shared with other stakeholders. Potential new diagnostic devices will need to be deployable to remote or distant communities, be affordable, identify and confirm infection status before treatment in patients whose diagnosis of urinary schistosomiasis is based on self-reporting, and equip health care facilities with diagnostic devices optimized for the local setting while requiring local minimal infrastructural settings. Similarly, the context of use and application of a potential new diagnostic device for urinary schistosomiasis is primarily associated with the tasks stakeholders throughout the health care system perform or procedures employed. These findings will guide the development of new diagnostic devices for schistosomiasis that match the contextual landscape and diagnostic strategies in Oyo. ...
Journal article (2021) - A.A. Onasanya, M.L. Bengtson, Oladimeji Oladepo, J.M.L. van Engelen, J.C. Diehl
The control and elimination of schistosomiasis have over the last two decades involved several strategies, with the current strategy by the World Health Organization (WHO)
focusing mainly on treatment with praziquantel during mass drug administration (MDA). However, the disease context is complex with an interplay of social, economic, political, and cultural factors that may affect achieving the goals of the Neglected Tropical Disease (NTD) 2021-2030 Roadmap. There is a need to revisit the current top-down and reactive approach to schistosomiasis control among sub-Saharan African countries and advocate for a dynamic and diversified approach. This paper highlights the challenges of praziquantel-focused policy for schistosomiasis control and new ways to move from schistosomiasis control to elimination in sub-Saharan Africa. We will also discuss an alternative and diversified approach that consists of a Systems Thinking Framework that embraces intersectoral collaboration fully and includes co-creating locally relevant strategies with affected communities.We propose that achieving the goals for control and elimination of schistosomiasis requires a bottom-up and pro-active approach involving multiple stakeholders. Such a pro-active integrated approach will pave the way for achieving the goals of the NTD 2021-2030 roadmap for schistosomiasis, and ultimately
improve the wellbeing of those living in endemic areas. ...
Journal article (2020) - A.A. Onasanya, Maryam Keshinro, Oladimeji Oladepo, J.M.L. van Engelen, J.C. Diehl
Background: Schistosomiasis, one of the neglected tropical diseases, is a water-based parasitic disease of public health importance. Currently, tests for Schistosoma haematobium infection either demonstrate poor specificity, are expensive or too laborious for use in endemic countries, creating a need for more sensitive, cheaper, and easy to use devices for the diagnosis of schistosomiasis. To ensure engagement during the process of device development; and effective acceptance and use after the introduction of diagnostics devices for S. haematobium, there is a need to involve stakeholders with varying power, interest, and stakes in device co-creation, as well as those relevant for later use situation in the diagnostic landscape. The main goal of this study is to identify and analyze relevant stakeholders for co-creation using a power-interest matrix.

Materials and Methods: The study was based on an action research methodology using a case study approach. A contextual inquiry approach consisting of 2 stages: stakeholder identification and interview; and stakeholder analysis was used. The field part of the study was carried out in Oyo State, Nigeria using a multistage cluster purposive sampling technique based on the category of stakeholders to be interviewed predicated on the organizational structure within the state and communities. A mix of qualitative research techniques was used. Identified themes related to power and interest were mapped and analyzed.

Results: We identified 17 characteristics of stakeholders across 7 categories of stakeholders important for schistosomiasis diagnostics. Most of the stakeholders were important for both the co-creation and adoption phase of the device development for diagnostics. However, not all stakeholders were relevant to co-creation. Key Stakeholders relevant for diagnostics co-creation demonstrated significant social power, organization power, and legitimate power bases. Most of the stakeholders showed significant interest in the device to be created.

Discussion: The power and interest of these stakeholders reveal some insight into how each stakeholder may be engaged for both co-creation and device usage. The involvement of relevant actors who will also be important for co-creation and implementation, will simplify the engagement process for the critical stakeholders, increase the ability to manage the process, and increase diagnostic device acceptability. ...
Journal article (2020) - G. Young Van, Adeola Onasanya, Jo Van Engelen, Oladimeji Oladepo, Jan Carel Diehl
Schistosomiasis is one of the Neglected Tropical Diseases that affects over 200 million people worldwide, of which 29million people in Nigeria. The principal strategy for schistosomiasis in Nigeria is a control and elimination program which comprises a school-based Mass Drug Administration (MDA)with limitations of high re-infection rates and the exclusion of high-risk populations. TheWorld Health Organization (WHO) recommends guided case management of schistosomiasis (diagnostic tests or symptom-based detection plus treatment) at the Primary Health Care (PHC) level to ensure more comprehensive morbidity control. However, these require experienced personnel with sufficient knowledge of symptoms and functioning laboratory equipment. Little is known aboutwhere, bywhom and how diagnosis is performed at health facilities within the case management of schistosomiasis in Nigeria. Furthermore, there is a paucity of information on patients' health-seeking behaviour from the onset of disease symptoms until a cure is obtained. In this study, we describe both perspectives in Oyo state, Nigeria and address the barriers using adapted health-seeking stages and access framework. The opportunities for improving case management were identified, such as a prevalence study of high-risk groups, community education and screening, enhancing diagnostic capacity at the PHC through point-of-care diagnostics and strengthening the capability of health workers. ...
Conference paper (2020) - M.M. Sluiter, A.A. Onasanya, Oladimeji Oladepo, J.M.L. van Engelen, Myryam Keshinro, T.E. Agbana, G.Y. Van, J.C. Diehl
Schistosomiasis is a treatable and preventable neglected tropical disease of Public Health importance affecting over 200 million people worldwide while Nigeria is one of the high burden countries. Currently, available diagnostic tests are cumbersome, low in sensitivity and not field-adaptable given the high skills required that are not available in the rural settings where the diseases are majorly prevalent. There is an urgent need for an easy to use automated diagnostic device to replace the current gold standard, the human-operated microscope. Many promising automated diagnostic technologies are under development. However, a good understanding of the real needs within the local healthcare context is crucial in order to develop and implement a new health diagnostic device. Too often, there is a mismatch between what is needed and what is developed. A target product profile can guide the R&D process in matching with the needs in the local healthcare context. The goal of this project is to combine gaps in the healthcare system and needs from stakeholders with technological possibilities in order to develop a target product profile for a diagnostic device for S. haematobium for specific healthcare scenarios in Nigeria. ...