FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States.

Diagnosing infectious diseases significantly influences patient care, aiding in outbreak identification, response, and public health monitoring. However, the range of FDA-approved molecular tests remains notably limited, especially concerning neglected tropical diseases (NTDs). Drawing upon our experience as one of the largest healthcare networks in the greater New York metropolitan area, this viewpoint manuscript aims to spotlight the existing diagnostic landscape and unmet clinical needs for 4 emerging NTDs increasingly prevalent in the United States, additionally, it delves into the possible adverse effects of the FDA's Proposed Rule on Laboratory-Developed Tests for these clinical conditions and the broader spectrum of NTDs.

Protocol for the crowdsourced image-based morbidity hotspot surveillance for neglected tropical diseases (CIMS-NTDs).

INTRODUCTION: Efficient NTDs elimination strategies require effective surveillance and targeted interventions. Traditional methods are costly and time-consuming, often failing to cover entire populations in case of movement restrictions. To address these challenges, a morbidity image-based surveillance system is being developed. This innovative approach which leverages the smartphone technology aims at simultaneous surveillance of multiple NTDs, enhancing cost-efficiency, reliability, and community involvement, particularly in areas with movement constraints. Moreover, it holds promise for post-elimination surveillance. METHODOLOGY: The pilot of this method will be conducted across three states in southern Nigeria. It will target people affected by Neglected Tropical Diseases and members of their communities. The new surveillance method will be introduced to target communities in the selected states through community stakeholder's advocacy meetings and awareness campaigns. The pilot which is set to span eighteen months, entails sensitizing NTDs-affected individuals and community members using signposts, posters, and handbills, to capture photos of NTDs manifestations upon notice using smartphones. These images, along with pertinent demographic information, will be transmitted to a dedicated server through WhatsApp or Telegram accounts. The received images will be reviewed and organized at backend and then forwarded to a panel of experts for identification and annotation to specific NTDs. Data generated, along with geocoordinate information, will be used to create NTDs morbidity hotspot maps using ArcGIS. Accompanying metadata will be used to generate geographic and demographic distributions of various NTDs identified. To protect privacy, people will be encouraged to send manifestation photos of the affected body part only without any identifiable features. EVALUATION PROTOCOL: NTDs prevalence data obtained using conventional surveillance methods from both the pilot and selected control states during the pilot period will be compared with data from the CIMS-NTDs method to determine its effectiveness. EXPECTED RESULTS AND CONCLUSION: It is expected that an effective, privacy-conscious, population inclusive new method for NTDs surveillance, with the potential to yield real-time data for the identification of morbidity hotspots and distribution patterns of NTDs will be established. The results will provide insights into the effectiveness of the new surveillance method in comparison to traditional approaches, potentially advancing NTDs elimination strategies.

Financial hardship among patients suffering from neglected tropical diseases: A systematic review and meta-analysis of global literature.

INTRODUCTION: Neglected tropical diseases (NTDs) mainly affect underprivileged populations, potentially resulting in catastrophic health spending (CHS) and impoverishment from out-of-pocket (OOP) costs. This systematic review aimed to summarize the financial hardship caused by NTDs. METHODS: We searched PubMed, EMBASE, EconLit, OpenGrey, and EBSCO Open Dissertations, for articles reporting financial hardship caused by NTDs from database inception to January 1, 2023. We summarized the study findings and methodological characteristics. Meta-analyses were performed to pool the prevalence of CHS. Heterogeneity was evaluated using the I2 statistic. RESULTS: Ten out of 1,768 studies were included, assessing CHS (n = 10) and impoverishment (n = 1) among 2,761 patients with six NTDs (Buruli ulcer, chikungunya, dengue, visceral leishmaniasis, leprosy, and lymphatic filariasis). CHS was defined differently across studies. Prevalence of CHS due to OOP costs was relatively low among patients with leprosy (0.0-11.0%), dengue (12.5%), and lymphatic filariasis (0.0-23.0%), and relatively high among patients with Buruli ulcers (45.6%). Prevalence of CHS varied widely among patients with chikungunya (11.9-99.3%) and visceral leishmaniasis (24.6-91.8%). Meta-analysis showed that the pooled prevalence of CHS due to OOP costs of visceral leishmaniasis was 73% (95% CI; 65-80%, n = 2, I2 = 0.00%). Costs of visceral leishmaniasis impoverished 20-26% of the 61 households investigated, depending on the costs captured. The reported costs did not capture the financial burden hidden by the abandonment of seeking healthcare. CONCLUSION: NTDs lead to a substantial number of households facing financial hardship. However, financial hardship caused by NTDs was not comprehensively evaluated in the literature. To develop evidence-informed strategies to minimize the financial hardship caused by NTDs, studies should evaluate the factors contributing to financial hardship across household characteristics, disease stages, and treatment-seeking behaviors.

The effects of selected neglected tropical diseases on economic performance at the macrolevel in Africa.

BACKGROUND: Neglected tropical diseases (NTDs) such as leprosy, lymphatic filariasis (LF), schistosomiasis and onchocerciasis are endemic in several African countries. These diseases can lead to severe pain and permanent disability, which can negatively affect the economic productivity of the affected person(s), and hence resulting into low economic performance at the macrolevel. Nonetheless, empirical evidence of the effects of these NTDs on economic performance at the macrolevel is sparse. This study therefore investigates the effects of the above-mentioned NTDs on economic performance at the macrolevel in Africa. METHODS: The study employs a panel design with data comprising 24 to 45 African countries depending on the NTD in question, over the period, 2002 to 2019. Gross domestic product (GDP) is used as the proxy for economic performance (Dependent variable) and the prevalence of the above-mentioned NTDs are used as the main independent variables. The random effects (RE), fixed effects (FE) and the instrumental variable fixed effects (IVFE) panel data regressions are used as estimation techniques. RESULTS: We find that, an increase in the prevalence of the selected NTDs is associated with a fall in economic performance in the selected African countries, irrespective of the estimation technique used. Specifically, using the IVFE regression estimates, we find that a percentage increase in the prevalence of leprosy, LF, schistosomiasis and onchocerciasis is associated with a reduction in economic performance by 0.43%, 0.24%, 0.28% and 0.36% respectively, at either 1% or 5% level of significance. CONCLUSION: The findings highlight the need to increase attention and bolster integrated efforts or measures towards tackling these diseases in order to curb their deleterious effects on economic performance. Such measures can include effective mass drug administration (MDA), enhancing access to basic drinking water and sanitation among others.

Privileged small molecules against neglected tropical diseases: A perspective from structure activity relationships.

Neglected tropical diseases (NTDs) comprise diverse infections with more incidence in tropical/sub-tropical areas. In spite of preventive and therapeutic achievements, NTDs are yet serious threats to the public health. Epidemiological reports of world health organization (WHO) indicate that more than 1.5 billion people are afflicted with at least one NTD type. Among NTDs, leishmaniasis, chagas disease (CD) and human African trypanosomiasis (HAT) result in substantial morbidity and death, particularly within impoverished countries. The statistical facts call for robust efforts to manage the NTDs. Currently, most of the anti-NTD drugs are engaged with drug resistance, lack of efficient vaccines, limited spectrum of pharmacological effect and adverse reactions. To circumvent the issue, numerous scientific efforts have been directed to the synthesis and pharmacological development of chemical compounds as anti-infectious agents. A survey of the anti-NTD agents reveals that the majority of them possess privileged nitrogen, sulfur and oxygen-based heterocyclic structures. In this review, recent achievements in anti-infective small molecules against parasitic NTDs are described, particularly from the SAR (Structure activity relationship) perspective. We also explore current advocating strategies to extend the scope of anti-NTD agents.

Characteristics of Polish travellers admitted at the University Centre of Maritime and Tropical Medicine in Poland, 2023.

BACKGROUND: After COVID-19 restrictions were lifted, people started to travel again. Each year, thousands of Poles travel internationally, and many travel to tropical or subtropical destinations in Asia, Africa or South America. The aim of this article was to describe the characteristics of Polish travellers based on the information from a retrospective 12-month review of the medical records of Polish patients seeking pre-travel advice at the largest diagnostic and treatment travel medicine centre in Poland in 2023. MATERIAL AND METHODS: The retrospective study was based on the analysis of medical records of 2,147 patients seeking pre-travel advice at the University Centre of Maritime and Tropical Medicine in Gdynia, Poland, between January and December 2023. The study focused on the analysis of the following patients' variables: age, sex, travel details (purpose of travel, length of travel, departure month, continents and countries to be visited). It also aimed to evaluate the range of prevention measures which were either recommended or administered to patients seeking pre-travel advice at the clinic (preventive vaccinations, chemoprophylaxis). In addition, it assessed the health status of the patients presenting at the travel medicine clinic; retrospective health assessments were based on the information from the interviews with the patients. RESULTS: Patients who sought pre-travel advice were mostly aged 36-65 years (49.5%), they were travelling for tourism purposes (78.3%), for a maximum period of 4 weeks (79.0%), mostly in November (15.2%) or in January (14.9%). Most travellers planned to visit Asia (55.5%) or Africa (29.0%); mainly Thailand (21.5%), Vietnam (8.5%), Kenya (8.3%) or India (8.2%). The most frequently administered immunoprophylaxis included vaccinations against typhoid fever and hepatitis A. Other commonly recommended/prescribed prevention measures included: insect repellents (69.3%), sunscreen (58.3%), antimalarials (35.8%), antithrombotic drugs (32.6%), and antidiarrheal drugs (25.6%). The analysis of patient interviews demonstrated that 61.8% of the travellers consulted at the clinic had no pre-existing medical conditions, while 38.2% required the use of chronic medications, mainly for allergies (14.3%), thyroid disorders (13.6%), cardiovascular diseases (9.3%), or psychiatric disorders (5.5%). CONCLUSIONS: A large number of Polish travellers visit destinations where the risk of infectious and non-infectious diseases is high. Providing patients with professional advice during a pre-travel consultation will help protect against travel-associated health problems.

New Tools and Nuanced Interventions to Accelerate Achievement of the 2030 Roadmap for Neglected Tropical Diseases.

The World Health Organization roadmap for neglected tropical diseases (NTDs) sets out ambitious targets for disease control and elimination by 2030, including 90% fewer people requiring interventions against NTDs and the elimination of at least 1 NTD in 100 countries. Mathematical models are an important tool for understanding NTD dynamics, optimizing interventions, assessing the efficacy of new tools, and estimating the economic costs associated with control programs. As NTD control shifts to increased country ownership and programs progress toward disease elimination, tailored models that better incorporate local context and can help to address questions that are important for decision-making at the national level are gaining importance. In this introduction to the supplement, New Tools and Nuanced Interventions to Accelerate Achievement of the 2030 Roadmap for Neglected Tropical Diseases, we discuss current challenges in generating more locally relevant models and summarize how the articles in this supplement present novel ways in which NTD modeling can help to accelerate achievement and sustainability of the 2030 targets.

Accelerating Progress Towards the 2030 Neglected Tropical Diseases Targets: How Can Quantitative Modeling Support Programmatic Decisions?

Over the past decade, considerable progress has been made in the control, elimination, and eradication of neglected tropical diseases (NTDs). Despite these advances, most NTD programs have recently experienced important setbacks; for example, NTD interventions were some of the most frequently and severely impacted by service disruptions due to the coronavirus disease 2019 (COVID-19) pandemic. Mathematical modeling can help inform selection of interventions to meet the targets set out in the NTD road map 2021-2030, and such studies should prioritize questions that are relevant for decision-makers, especially those designing, implementing, and evaluating national and subnational programs. In September 2022, the World Health Organization hosted a stakeholder meeting to identify such priority modeling questions across a range of NTDs and to consider how modeling could inform local decision making. Here, we summarize the outputs of the meeting, highlight common themes in the questions being asked, and discuss how quantitative modeling can support programmatic decisions that may accelerate progress towards the 2030 targets.

Evaluating the World Health Organization's SkinNTDs App as a Training Tool for Skin Neglected Tropical Diseases in Ghana and Kenya: Cross-Sectional Study.

BACKGROUND: Neglected tropical diseases (NTDs) affect over 1.5 billion people worldwide, primarily impoverished populations in low- and middle-income countries. Skin NTDs, a significant subgroup, manifest primarily as skin lesions and require extensive diagnosis and treatment resources, including trained personnel and financial backing. The World Health Organization has introduced the SkinNTDs app, a mobile health tool designed to train and be used as a decision support tool for frontline health care workers. As most digital health guidelines prioritize the thorough evaluation of mobile health interventions, it is essential to conduct a rigorous and validated assessment of this app. OBJECTIVE: This study aims to assess the usability and user experience of World Health Organization SkinNTDs app (version 3) as a capacity-building tool and decision-support tool for frontline health care workers. METHODS: A cross-sectional study was conducted in Ghana and Kenya. Frontline health care workers dealing with skin NTDs were recruited through snowball sampling. They used the SkinNTDs app for at least 5 days before completing a web-based survey containing demographic variables and the user version of the Mobile Application Rating Scale (uMARS), a validated scale for assessing health apps. A smaller group of participants took part in semistructured interviews and one focus group. Quantitative data were analyzed using SPSS with a 95% CI and P≤.05 for statistical significance and qualitative data using ATLAS.ti to identify attributes, cluster themes, and code various dimensions that were explored. RESULTS: Overall, 60 participants participated in the quantitative phase and 17 in the qualitative phase. The SkinNTDs app scored highly on the uMARS questionnaire, with an app quality mean score of 4.02 (SD 0.47) of 5, a subjective quality score of 3.82 (SD 0.61) of 5, and a perceived impact of 4.47 (SD 0.56) of 5. There was no significant association between the app quality mean score and any of the categorical variables examined, according to Pearson correlation analysis; app quality mean score vs age (P=.37), sex (P=.70), type of health worker (P=.35), country (P=.94), work context (P=.17), frequency of dealing with skin NTDs (P=.09), and dermatology experience (P=.63). Qualitative results echoed the quantitative outcomes, highlighting the ease of use, the offline functionality, and the potential utility for frontline health care workers in remote and resource-constrained settings. Areas for improvement were identified, such as enhancing the signs and symptoms section. CONCLUSIONS: The SkinNTDs app demonstrates notable usability and user-friendliness. The results indicate that the app could play a crucial role in improving capacity building of frontline health care workers dealing with skin NTDs. It could be improved in the future by including new features such as epidemiological context and direct contact with experts. The possibility of using the app as a diagnostic tool should be considered. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/39393.

Using Passive Surveillance to Maintain Elimination as a Public Health Problem for Neglected Tropical Diseases: A Model-Based Exploration.

BACKGROUND: Great progress is being made toward the goal of elimination as a public health problem for neglected tropical diseases such as leprosy, human African trypanosomiasis, Buruli ulcer, and visceral leishmaniasis, which relies on intensified disease management and case finding. However, strategies for maintaining this goal are still under discussion. Passive surveillance is a core pillar of a long-term, sustainable surveillance program. METHODS: We use a generic model of disease transmission with slow epidemic growth rates and cases detected through severe symptoms and passive detection to evaluate under what circumstances passive detection alone can keep transmission under control. RESULTS: Reducing the period of infectiousness due to decreasing time to treatment has a small effect on reducing transmission. Therefore, to prevent resurgence, passive surveillance needs to be very efficient. For some diseases, the treatment time and level of passive detection needed to prevent resurgence is unlikely to be obtainable. CONCLUSIONS: The success of a passive surveillance program crucially depends on what proportion of cases are detected, how much of their infectious period is reduced, and the underlying reproduction number of the disease. Modeling suggests that relying on passive detection alone is unlikely to be enough to maintain elimination goals.

Windows of opportunity in integrating mental health into care of neglected tropical diseases: the Nigeria experience.

In this invited commentary, the Mental Health and the Neglected Tropical Diseases(NTDs) Program leads in the Nigerian Federal Ministry of Health and Social Welfare share the opportunities that have arisen from recent global progress in normative guidance and political interest in the intersection of mental health and NTDs. They describe the new collaboration that has taken place between their programs, e.g. contributing to the World Health Organization Essential Care Package for Mental Health, Stigma and NTDs and integration of mental health for the first time into the new National NTD Masterplan.

Let them talk and we listen: what are diseases of neglected people?

This article is a reflection from a person with lived experience of leprosy, who has been working as a global advocate and champion for the rights of persons affected by neglected tropical diseases for the last decade. Synthesising learning from the collection of pieces included within this special supplement that are written from the perspective of people affected by neglected tropical diseases, I argue that it is time to centre the lived experiences of people affected by neglected tropical diseases. These are diseases of neglected people, and it is now time to let them talk while we listen.

Prevalence, assessment and correlates of mental health problems in neglected tropical diseases: a systematic review.

Neglected tropical diseases (NTDs) are a group of disease conditions that affect the world's poorest people in low- and middle-income countries. NTDs are associated with negative behavioural experiences, including discrimination, rejection and stigmatization, that predisposes those affected to mental health problems. Consequently, researchers have shown profound interest in elucidating the mental health burden associated with NTDs. To address pertinent issues in the burgeoning literature relating to the prevalence, assessment and correlates of mental health problems in NTDs, a systematic review methodology was used. Underpinned by the PRISMA guidelines, a search was conducted of electronic databases, individual journals and bibliographies for articles that were screened and subjected to predetermined inclusion and exclusion criteria. Sixteen articles from African, Asian and South American countries were included in the review. Depression was the most widely investigated mental health issue, followed by stress and anxiety, with prevalence estimates of 7-54%, 8-43% and 19-53%, respectively. The PHQ-9 and GAD-7 and Self-Reporting Questionnaire were the most widely administered mental health screening tools. The major correlates of mental health problems are lower education and economic status and female gender. We recommend multisectoral and multilayered mental health and related interventions to address the increasing burden of mental health in NTDs.

Imported infectious diseases in migrants from Latin America: A retrospective study from a referral centre for tropical diseases in Spain, 2017-2022.

INTRODUCTION: Detecting imported diseases by migrants and individuals visiting friends and relatives (VFR) is key in the prevention and management of emergent infectious diseases acquired abroad. METHODS: Retrospective descriptive study on migrants and VFR from Central and South America between 2017 and 2022 attended at a National Referral Centre for Tropical Diseases in Madrid, Spain. Demographic characteristics, syndromes and confirmed travel-related diagnoses were obtained from hospital patient medical records. RESULTS: 1654 cases were registered, median age of 42 years, 69.1% were female, and 55.2% were migrants. Most cases came from Bolivia (49.6%), followed by Ecuador (12.9%). Health screening while asymptomatic (31.6%) was the main reason for consultation, followed by Chagas disease follow-up (31%). Of those asymptomatic at screening, 47,2% were finally diagnosed of any disease, mainly Chagas disease (19,7%) and strongyloidiasis (10,2%) CONCLUSION: Our study emphasizes the importance of proactive health screening to detect asymptomatic conditions in migrants and VFR, enabling timely intervention and improved health outcomes. By understanding the unique health profiles of immigrant populations, targeted public health interventions can be devised to safeguard the well-being of these vulnerable groups.

Next-generation vaccines for tropical infectious diseases.

Tropical infectious diseases inflict an unacceptable burden of disease on humans living in developing countries. Although anti-pathogenic drugs have been widely used, they carry a constant threat of selecting for resistance. Vaccines offer a promising means by which to enhance the global control of tropical infectious diseases; however, these have been difficult to develop, mostly because of the complex nature of the pathogen lifecycles. Here, we present recently developed vaccine candidates for five tropical infectious diseases in the form of a catalog that have either entered clinical trials or have been licensed for use. We deliberate on recently licensed dengue vaccines, provide evidence why combination vaccination could have a synergistic impact on schistosomiasis, critically appraise the value of typhoid conjugate vaccines, and discuss the potential of vaccines in the efforts to eliminate vivax malaria and hookworms.

Original algorithms for the detection of cardiovascular involvement of neglected tropical diseases.

INTRODUCTION: Neglected tropical diseases (NTDs) introduce considerable morbidity and mortality on a global scale, directly impacting over 1 billion individuals as well as their families and communities. Afflicted individuals may have limited access to resources and care in these regions, contributing to a high proportion of chronic, progressive, and systemic disease. The cardiovascular system is at particular risk of demise for several NTDs, yet remains largely unstudied due in part to the lack of robust data collection mechanisms in the most impacted regions. AREAS COVERED: The present review is a part of the Neglected Tropical Diseases and other Infectious Diseases affecting the Heart (NET-Heart) Project, aiming at summarizing the current knowledge on cardiovascular implications of NTDs and providing diagnostic as well as management recommendations which can be tailored to low-resource settings. The diagnostic and management algorithms of 13 unique NTDs are presented and summarized. EXPERT OPINION: Recognizing cardiac manifestations of NTDs can significantly alter disease trajectory and all physicians benefit from improved knowledge about NTDs. Great potential exists to advance patient care by improving data collection, communication, and international collaboration.