During the last few years, the continuous emergence of new psychoactive substances (NPS) has become an important public health challenge. The use of NPS has been rising in two different ways: buying and consuming NPS knowingly and the presence of NPS in traditional drugs as adulterants. The rise of NPS use is increasing the number of different substances in the market to an extent impossible to study with current scientific methodologies. This has caused a remarkable absence of necessary information about newer drug effects on people who use drugs, mental health professionals, and policy makers. Current scientific methodologies have failed to provide enough data in the timeframe when critical decisions must be made, being not only too slow but also too square. Last but not least, they dramatically lack the high resolution of phenomenological details.This study aims to characterize a population of e-psychonauts and the subjective effects of the NPS they used during the study period using a new, internet-based, fast, and inexpensive methodology. This will allow bridging an evidence gap between online surveys, which do not provide substance confirmation, and clinical trials, which are too slow and expensive to keep up with the new substances appearing every week.To cover this purpose, we designed a highly personalized, observational longitudinal study methodology. Participants will be recruited from online communities of people who use NPS, and they will be followed online by means of a continuous objective and qualitative evaluation lasting for at least 1 year. In addition, participants will send samples of the substances they intend to use during that period, so they can be analyzed and matched with the effects they report on the questionnaires.The research protocol was approved by the Institutional Review Board of the Hospital del Mar Research Institute on December 11, 2018. Data collection started in August 2019 and was still ongoing when the protocol was submitted (September 2020). The first data collection period of the study ended in October 2020. Data analysis began in November 2020, and it is still ongoing. The authors expect to submit the first results for publication by the end of 2021. A preliminary analysis was conducted when the manuscript was submitted and was reviewed after it was accepted in February 2021.It is possible to conduct an institutional review board–approved study using this new methodology and collect the expected data. However, the meaning and usefulness of these data are still unknown.DERR1-10.2196/24433 To date, new psychoactive substances (NPS) still represent a very important challenge to legislate, monitor, study, and develop health interventions. The understanding of use patterns remains poor, with most information being based on populations and settings where problems have already occurred .The ever-increasing number of psychoactive substances used nowadays represents a new challenge for psychiatry, as the pharmacodynamics and pharmacokinetics of many NPS are not yet thoroughly understood . In addiThis new phenomenon represents an unprecedented challenge in the field of drug use as well as a fast-growing problem from social, cultural, legal, and political perspectives .designer drugs, legal highs, herbal highs, bath salts and research chemicals. Moreover, the term new does not necessarily refer to new inventions but to substances that have recently emerged on the market [new can include a failed pharmaceutical or an old patent that has been rediscovered for recreational substance [NPS are substances of abuse, either in a pure form or a preparation, that are not controlled by the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances but which may pose a public health threat. It is important to note that different authors have previously referred to them as e market . Hence, ubstance .Another distinction being made is between NPS and emerging psychoactive substances, where the latter term captures all NPS as well as drugs that may not be newly invented but have recently experienced a resurgence of, or increase in, use . HoweverBetween 2009 and 2017, 803 NPS were reported in 111 countries or territories . In the There is an ongoing debate on the scale of challenges posed by NPS, as the evidence on the prevalence of NPS use is scarce. For example, general population surveys suggest that the prevalence of NPS use is relatively low, with the best estimates found in the scientific literature being between 1% and 2% in the United Kingdom. However, the speed of technological innovation and the ease of synthesizing NPS present substantial challenges to regulatory authorities, researchers, and clinicians ,8.NPS may now pose a big challenge due to several factors:NPS consist of several different classes of substances, which vary in their psychological and physiological effects. Treatment is often difficult because of the young age of most users and the possibility of concurrent polysubstance use. The pattern of use is often intermittent in social settings, so it may be perceived as less of a problem .NPS appear into—and sometimes disappear from—the market very quickly, and as such, they are not significantly impacted by regulatory efforts. Currently, new substances are identified in Europe at a rate of one or more per week . Severalstreet to a web market [dark net [NPS are mainly distributed through the internet in a transnational market without solid information about their effects and risks . During b market . The incdark net .NPS can substitute traditional drugs in times when their availability is restricted . This coThere is a concerted effort to grapple with the challenges of researching NPS, as traditional methodologies are too slow and expensive to generate relevant and timely data on the effects of NPS .Clinicians are not usually able to identify a potential NPS user, and NPS usually produce negative results to traditional drug tests, which are designed to assess a very limited number of traditional substances . On the gaps in our understanding of the phenomena. From the evidence map about the NPS research performed by Mdege et al [Despite the high number of publications about NPS during the last 20 years, especially after a sharp increase in 2010, there are still concerning ge et al , 2 thinglow rates of studies coming from the internet population . In addition, these studies mainly reported severe intoxication or other acute NPS-related problems.First, most of the studies were performed in a general hospital population  or specialist settings , with relatively Second, the most frequent study design reported in the indexed peer-reviewed literature was case series and/or reports (n=367), followed by the literature review (n=243), the survey (n=130), and the secondary quantitative data analysis (n=99), with only 13 existing randomized controlled trials, 6 prospective cohort studies, and 1 case-control study ,8.specific limitations to the research performed till date. Although the most robust and representative data on NPS use are for mephedrone (surveys have been conducted in the United Kingdom since 2010), Mdege et al [there is no analytical confirmation of the true compound that was taken. Therefore, there is inherent uncertainty in the reported use of a particular NPS.There are also some ge et al  acknowleThe same authors also reported that sentinel populations are likely to be at a greater risk of NPS use. However, it remains mostly limited to attendees of nightclubs where different sexual orientations are accepted. Other authors have also remarked that only a handful of studies have moved beyond prevalence to explore subjective user experiences and motivations .Currently, the potential data sources that can provide some information on the acute effects of NPS consumption are as follows: (1) user self-reports on internet discussion forums, (2) surveys answered by users, and (3) fatal and nonfatal case reports.Self-reports and surveys are mostly based on self-reported use rather than the analytical confirmation of the substances used. In contrast, case reports are usually generated from hospital settings in the context of an intoxication or overdose with multiple substances involved, so there is analytical confirmation of the substance but no self-reported effects. Unsurprisingly, the literature is dominated by studies investigating the problems associated with NPS . Therefore, caution is required when interpreting these data because of the following limitations:Users will report what they believe they have used, rather than whatever substance is actually taken .Intoxications with multiple substances in hospital settings do not target the information on psychopharmacological effects of a particular NPS ,8.In their empirical and conceptual review to produce research recommendations, Mdege et al  provide The need to be aware of innovation opportunities, such as testing emerging NPS brands online as they become available.Using cohort study designs to better understand the determinants of NPS use and related physical and mental health, psychosocial problems, and how patterns of involvement and consequences change over time.What are the prevalence and patterns of NPS use in the general UK population and do they differ between subgroups of the population?Are there sentinel populations capable of being monitored to provide early warnings of new trends?Which acute intoxication problems are associated with NPS use?Which promising approaches are currently available or can be made available in the United Kingdom for intervening with NPS use?Finally, they concluded that there is a need for a major research effort to be directed at NPS, which should address NPS together with other forms of licit and illicit drug use ,8.necessity of conducting a longitudinal study in a specific and potential sentinel population, such as internet NPS–consuming communities. This would allow for early assessments of the effects of recently emerged drugs and to study the patterns of consumption, harm reduction strategies, and long-term drug-related problems.Both the limitations and recommendations stated above lead to the Available data on sentinel populations are growing. For example, several studies of attendees of gay-friendly night clubs suggest that the trend in reduction of mephedrone witnessed nationally may also occur in this subgroup. However, the study of this sentinel population has failed to predict future harms and trends in the global NPS market .Conversely, data on another sentinel population, namely, e-psychonauts, have been able to predict future NPS-related harms occurring in more general settings .e-psychonauts has been considered by several authors as potentially useful in identifying NPS availability, market, and diffusion in advance. This population is believed to be responsible for shaping and influencing the drug scenarios of the future [In fact, the sentinel population of e future . In addie future  providednormal, everyday settings with the intention of subjectively exploring their effects.The term psychonaut was first described by Newcombe  as an adcyber-psychonauts to refer to their sample composed predominantly of NPS consumers. Cyber-psychonauts are further defined by their commitment to harm reduction, to using NPS safely and responsibly, and to purchasing chemicals online [Some years later, O’Brien et al  coined ts online .experts in using NPS, providing a contrasting narrative around drug use and risk to that established by the scientific community. A brief perusal of relevant websites confirms the existence of a great number of NPS-related discussion threads, suggesting the existence of an online community of more discerning NPS users [Tackett-Gibson  also docPS users .educated and informed users within web-based drug forum communities, who can provide reliable information on psychoactive compounds. They refer to these users as e-psychonauts, providing the best characterization of the population to date [soul; high standards of knowledge about drugs’ chemical and pharmacological issues; and high levels of both technology-related skills. They are meant to have a wide vocabulary to define their own on drug experiences in the most subtle and precise way possible.Orsolini et al  also ref to date . The e-pAmong this population, the frequency of NPS use is high, with one-third of the participants reporting its use in the last week. They view themselves as knowledgeable consumers who use the internet to accumulate information about NPS and share their own experiences, informing fellow users of potential harms. However, other studies  reportedon drug experience report is arguably the trait d’union of all e-psychonauts, considering the intention behind using a substance is the most significant difference between a psychonaut and a typical drug user. O’Brien et al [This community may have some other distinct characteristics. A minority of the sample reported that an NPS was the first drug that they had ever taken. Of those who ceased using NPS, majority found it either easy or very easy to stop. Most commonly, cessation was due to the side effects of NPS . They alen et al  also ideSeveral authors have tried to engage cyber-psychonauts as research participants. Mdege et al  found diDifferent authors believe that these internet communities are a huge opportunity for researchers. The qualitative analysis of how different groups interact with online communities may help to systematize and codify needs, values, and preferences that are relevant to the group . In inteSome authors even consider cyber-psychonauts to be ideally placed to become involved in the actual implementation of innovative responses to the increasing prominence of NPS markets, as it is difficult to imagine a more efficient method for the rapid dissemination of new information about things such as the adverse effects of new products to consumers .The recent alarm related to the growth of the NPS market and the gradual shift from the street to the cyber-drug market may call for the implementation of preventive tools and practices tailored to these new drug users’ characteristics .Finally, in their empirical and conceptual revision of the NPS research field, Mdege et al  concludeIt is clear then that this sentinel population might be difficult to reach and retain in a highly structured study protocol ,18,21,25X study participants and engage them in the old trial machinery, drug X has already become obsolete and has been replaced by Y and—possibly—even Z drugs.In summary, NPS pose a public health threat at different levels, and there is a lack of research on the effects of the emerging substances as well as on which ones are appearing now. In addition, the research conducted to date has been unable to cover important gaps, such as studying relevant sentinel populations of e-psychonauts using new technologies, involving them in the research, and obtaining confirmatory analytical data of the substances studied. Old methodologies repeatedly fail to reach the skyrocketing turnover pace of newer NPS in the e-market. By the time old trials recruit the necessary drug This study aims to bridge the abovementioned evidence gaps. To do so, a naturalistic, observational, and longitudinal design has been adopted, recruiting e-psychonauts to gather information on their characteristics and the substances that they might be using before their popularization. This has been possible thanks to the development of a new online ad hoc tool designed for this project: an online platform thought to enhance communication with the e-psychonauts and allow community building. In addition, subjective effects on these substances have been studied, allowing the participants to send samples to a partner laboratory with gas chromatography (GC)/mass spectrometry (MS) in Barcelona and administering drug effect questionnaires in the most resembling way possible to the drug laboratory studies.This design has resulted in the first internet-based, multinational study on a key sentinel population with laboratory confirmation on the composition of the reported samples.The study has been designed to answer 3 main research questions:Who are the people who first try the new substances when they emerge in the market?What are the substances emerging right now and their subjective effects?Is it possible to collect reliable data to answer these questions using a low-budget internet platform and the design used in this study?The researchers’ initial hypotheses are as follows:The population of e-psychonauts will be made up of functional and educated people who use drugs mainly in a recreational way.During the study period, we will be able to identify a wide variety of different substances, some of which have never been reported before in the scientific literature or by the organizations aimed at controlling illicit drug supply.The study design and implementation will attract enough research participants with sufficient commitment to provide valuable, reliable, and meaningful data to generate quality evidence.This study aims to discover the characteristics of the e-psychonaut population and the effects of the NPS they use, with a longitudinal design and no control group. The study is conducted online, recruiting participants using an innovative and specifically developed platform as part of the study project: Global Research and Analysis of New Substances Project (GRASP).The study has been designed and will be reported using the Checklist for Reporting Results of Internet E-Surveys  and the The study protocol was submitted in October 2018 and was approved by the Clinical Research Ethics Committee  in January 2019. The study was conducted according to the Declaration of Helsinki recommendations and the emerging recommendations for online research on sensible topics ,25. All The study is conducted mainly though internet, using 3 main tools:The specifically designed GRASP platformQualtrics survey service licensed though Columbia UniversityThe The Google Suite platform as an email service to contact candidates and attend to the private questions and concerns of the study participants.In addition, the samples were received through traditional mail in the EC Headquarters in Barcelona, where they were initially processed and identified. The samples were then transported to the EC laboratory at the Hospital del Mar Research Institute (IMIM), second floor, to be analyzed using the techniques described below. The research team worked at both the EC headquarters and the IMIM laboratories. During the COVID-related lockdown that was established in Spain in March 2020, the laboratory analysis was interrupted for 3 months.sending an email with a specific link to a questionnaire, and the logic pathways (adaptive questioning) and validation requirements used in the Qualtrics questionnaires were systematically tested by the research team. A checklist of all possible scenarios was devised, and they were all executed by a blind research team member and the principal investigator. Once errors were identified, they were corrected, and the process was repeated from the beginning. In addition, participants were encouraged to report any problems or ideas to improve the procedures, so changes could be implemented when needed during the study.The usability of the platform and the multiple automated processes, such as IMIM, Barcelona. The cost of this service is US $110 if contracted independently through the EC International Drug Checking Service.All the participants were correctly and fully informed by writing , except the following:Previous participation in forums has been assessed by self-report and exclusive advertisement of the study on these forums.Difficulties in using new technologies have been assessed by the steps required to complete the screening process, such as sending an IC form in a particular format, registering to the platform, and following the instructions there to introduce themselves to the research team and other participants.Difficulties in communicating in English and the presence of potential psychopathological impairments have also been evaluated by the principal investigator, assessing the answers to long and elaborate open questions in the screening questionnaire (Q0) and in the written introductions to the online platform.The potential of being pregnant was assessed by indirect questioning using the same screening questionnaire (Q0) questionnaire.Recruitment ads were sent to the moderators of the selected online communities after establishing bilateral communication with them, mainly to ask permission and explain the goals of the project. To maximize interest in participating in the study, the only focus was on establishing rapport with community leaders, as if they share their interest in the study, they will be able to transfer it to the rest of the community . Each coThe operational definition for online communities of people who use NPS has been adapted from the study by Barratt :Surface websites with at least 5 years of existencePresence of participation forums dedicated to discussing the use of NPSAt least weekly activity on the community forumThe use of pseudo-anonymity by community members to identify themselvesThe presence of official and analytical drug checking services in the community.When the study design was completed (October 2018), there were 4 communities meeting the previously stated criteria :Bluelight [luelight : Establiluelight . RegistrReddit [Reddit : EstabliDrugs-forum [gs-forum : EstabliDNstarsVIP: Established after discussing about NPS sources was banned on the reddit community, DNstars is a strongly emerging community with approximately 2000 users. Registration is required to access the content.The main communities that were assessed and excluded were as follows:Legal-highs forum: excluded because of the lack of weekly interactions, technical website problems, and impossibility to contact community managers.Erowid: excluded because of the lack of an active forum.Psychonaut wiki: excluded because of the lack of an active forum.Tripsit: excluded because of the lack of an active forum, although there was an internet relay chat–supported chatroom.Dimethyltriptamine-nexus: excluded because of the lack of a specific NPS subsection.Ecstasy data: excluded because of the lack of an active forum and the lack of a specific NPS subsection.Shroomery: Excluded because of the lack of a specific NPS subsection.bluelight, drugs-forum, and legal-highs forum as the top 3 communities. However, they did not consider collaboration with drug checking organizations to be a relevant factor. Moreover, as stated above, these rankings are expected to change over relatively short periods [To the best of the authors’ knowledge, the selected communities were the main ones at the moment when the selection occurred (October 2018), although it has to be acknowledged that this is a rapidly changing scenario; in a few years, this same process might produce different outcomes. At that moment, the authors were unable to find any contradicting information with that assumption. Soussan et al  referred periods .The GRASP platform, which allowed for interaction among participants themselves and with the research team, was the main tool to promote participant engagement and minimize dropout rates.In the most recent review consulted by the authors, the sample sizes reached with web-based questionnaires in people who use illicit drugs ranged from 80 to 9867 . The expinformation for candidates’ sheet to their email . This questionnaire was available to each participant through a participant-specific link, which was sent by email once they were accepted. After that, participants were asked to fill the sample submission questionnaire (Q2), where information about the sample they intended to consume was asked. This questionnaire was then reviewed by the principal investigator and approved if the substance met the study criteria of being a new psychoactive substance. The samples that did not meet the inclusion criteria were not accepted, and the participant was notified by email. The sample submission questionnaire (Q2) was available to all accepted participants as a link on the platform. All the questionnaire answers were reviewed weekly by a member of the research team to communicate to the participant the acceptance of the sample and to mark them as valid or invalid data for later analysis.If the sample was approved, the participant received a specifically generated sample code with the instructions to send a small amount of the sample  via traditional mail to the laboratory at the IMIM. The sample was analyzed there, and the result was sent back to the user, along with harm reduction advice when appropriate.Meanwhile, the users could consume the substance whenever they decided, as the study was intended to be observational. However, most of the participants waited until they had the result of the laboratory analysis to proceed with the self-administration trial. The self-administration trial started with the users filling the drug effect baseline questionnaire (Q3a), and then, they consumed the reported substance and filled the drug effect questionnaire (Q3b) 24 hours after filling the baseline questionnaire (Q3a). The links to these questionnaires were available for all participants in the forum, and the veracity of the information was ensured by asking information only available to each participant, such as the sample code of the reported sample.Study recruitment began in August 2019 and is still ongoing. In August 2020, the first participant concluded the 1-year follow-up.The protocol has been subjected to amendments twice, both approved by the IRB of the institution .The first amendment, submitted in January 2019, reported the following changes in the protocol:Minor changes in the study advertisement sheet, participant information sheet, and IC formThe assessment of inclusion criteria was no longer done by the community moderators and was entirely assessed by self-reporting on online questionnairesAn increase in the required sample quantity to be sent to the laboratory from 30 to 50 mg by default, accepting exceptions depending on the substance potencyAddition of a key measurement timepoint at baseline before ingesting the substance.The second amendment, submitted in November 2019, reported the following changes in the protocol:Unblinding of the research team to the participant behavior and participationAddition of an optional timepoint for data collection in the reporting of the subjective effects of the reported substancesExtension of the duration of the study from 6 months to 1 year for each participantReduction of the required age for inclusion from 21 to 18 years.The domains and measurements used in the study are based on previous laboratory studies, to maximize consistency in methodology and to eventually develop a validation study for this methodology. Multiple studies have shown that web-based data collection and traditional methods  result in equivalent conclusions, demonstrating the validity and reliability of online data collection for research ,38.Certain studies have been used as model references to select the measured outcomes -52. Howeualtrics license, a well-known questionnaire platform compliant with the guidelines to store sensible information about the research participants. The screening questionnaire (Q0) and the sociodemographic questionnaire (Q1) collected self-reported information about the participants’ medical and drug history, psychosocial situation, and beliefs and behaviors related to drugs.The study data were collected using a Columbia University QThe subjective effects of drugs were assessed via visual analog scales, using the same parameters used in most laboratory studies to determine the subjective effects of drugs. The main outcome was the difference in mm from the drug effect questionnaire (Q3b) at 24 hours (referring to the peak experience) and the baseline questionnaire (Q3a).Qualtrics database. There were no automated consistency or completeness checks before the questionnaire was submitted, other than the validation criteria for certain questions. For example, the question sample code reported could not be submitted if the answer was not a 5-digit number.Each questionnaire also had at least one validity entry to be filled by the researcher directly using the Qualtrics database according to the correct response provided by the participant using email or the platform’s private messaging system. If the changes were relevant, the researcher could mark the questionnaire as invalid and provide another link to the participant.The participants could go back through the questionnaire, but once submitted, they could not change their answers. A summary of the answers was not displayed either before or after submission. Two options were available to change the participants’ answers if they were incorrect according to the participant or not valid according to the researcher. If the change was small, the researcher could just edit the participant response in the Public links to copies of the used questionnaires can be found in the references cited below:Q0, screening questionnaire : containQ1, sociodemographic questionnaire : containQ2, sample submission questionnaire : containQ3a, baseline drug effect questionnaire : containQ3b, drug effect questionnaire given 24 hours after drug administration : containQ4, 1-year follow-up questionnaire : containQualtrics software and varied according to the screen size used to answer. The possibility to answer the questionnaires comfortably from the smartphone was assessed as an essential by the research team.The number of pages and items on each page were optimized automatically by Preliminary sample identification was performed by GC coupled to MS using an Agilent 7890B gas chromatograph coupled to a 5977A quadrupole mass spectrometer detector (Agilent). The gas chromatograph was fitted with a G4513A auto-sampler injector. Insert liners packed with salinized glasswool were used, and the injector and interface were operated at 280 °C. Samples were injected in split mode into a 0.25 mm film thickness (5% phenylmethylsilicone) column . Helium was used as the carrier gas at a flow rate of 1 mL/min. The oven temperature was initially maintained at 90 °C for 2 minutes and programmed to reach 320 °C at 20 °C/min. It was finally maintained at 320 °C for 9.5 minutes . The mass spectrometer was operated in the electron impact ionization mode at 70 eV. To confirm the mass spectra, 4 libraries were used: the NIST/EPA/NIH Mass Spectral Library, Data Version: NIST 14; Searchable Mass Spectral Library Version 2.3 ; and EC’discourse  account and the software used to build the platform. Qualtrics  data were downloaded for analysis, which was conducted using the institutionally licensed Microsoft Excel from the IMIM and R (R Core Team), which is a free software environment for statistical computing and graphics that does not require a license.Secondary data about the participants’ discussions on the study platform were supported by a licensed Qualtrics software and will only be used according to the goals of the study described in the protocol. Most of the data will be entered directly by the participants, and a researcher will screen every questionnaire filled for consistency and ask the participants for clarifications in case of suspected errors in data entry or reporting. The principal investigator (MG) and 3 more researchers  will have access to the complete data sets. Data on participant performance will be entered manually by one researcher in an internal Excel database. No personal information will be stored other than the safe email address asked in the study advertisement and the nickname the participant choses to use in the forum. This ensures the maintenance of pseudo-anonymity, as information about the online persona will be stored, but the link between the online identity and the real identity will not be impossible to establish with the collected information.Data will be stored in Qualtrics software and initially analyzed using Excel by the research team. At the same time, an independent statistician will use the same data from Qualtrics to perform a partially blind analysis using R. Only fully completed and valid questionnaires will be analyzed. The validity of the questionnaires will be assessed by a research team member based only on the consistency and completeness of the participants’ answers.Data will be managed and processed using As it is an exploratory study, the data analysis procedures will be mainly descriptive statistics, to maximize an adequate visualization of the data collected within the minimum space. In addition, as there is no control group, statistical tests will be limited to potential comparisons to assess bias on the results, such as comparing data from participants who complete the study with participants who drop out or are excluded. However, no statistical corrections will be applied to adjust the representativeness of the sample, as this validation will be done by comparing the sociodemographics of the study sample with the characteristics of the population of psychonauts widely reported in the literature. Statistical tests might also be used to compare information from the initial questionnaire Q1 and the data from the follow-up questionnaire Q4. The nonparametric Wilcoxon signed-rank analysis will be used to perform a mean comparison of the quantitative data and the chi-square test for qualitative data. In addition, factor analysis will be attempted to study the relationship between all the visual analog scales used to assess the subjective drug effects.The data analysis will focus on the outcomes of the participants who completed the study. Data entries containing evident errors or inconsistent information will be discarded, and the extent to which this might have impacted the results will be reported.This study was approved by the IRB of IMIM on December 11, 2018, after the first submission in October 2018, when clarifications were asked and delivered in November 2018.The study has been designed and is being executed according to the basic principles of rights and dignity of the human being, as stated in the Helsinki declaration, and this study complies with all the current regulations that apply, including institutional, local, national, and international regulations.All information is being handled confidentially according to the organic Spanish law 15/1999 and the European regulation 2016/679. The IRB has always granted access to any study information required.All participants will receive the participant information sheet and will be required to read and fill the IC form, which will be sent to admin@grasp.pw. The principal investigator will be responsible for reviewing all candidates’ IC forms and screening questionnaires for inclusion and exclusion criteria. All candidates and participants will have the opportunity to ask as many questions as needed before proceeding to any part of the study, both through the forum and through contacting the leading researcher email (admin@grasp.pw).Participants will not be required to sign IC forms to protect their anonymity and avoid sharing data that could be used to track their physical identity. The identity that will be protected by the researchers will be the online one, as no other information relatable to the real identities will be given. This procedure is consistent with the methodology of previous studies .The researchers will try their best to limit the influence of their interactions on the participants’ behavior, especially the ones targeted in the study. However, as recommended by previous research, the participants will be involved in discussing the study design and incentivized to share their opinions on how the study could be improved ,21.Protocol changes will be communicated to the participants through the online platform once they are approved.A more extensive ethical analysis by principles can be found in All individual and collective data, as well as all the results derived from the study, will be strictly protected and will only be published with the authorization of the principal investigator and the affected participants. All relevant findings will be sent for publication in suitable journals and submitted for presentation at relevant scientific meetings. The funding organizations will have no role in the publication process. In addition, data without identifiable information will be shared with study participants after assessment and approval by the research team. Finally, all results published in the scientific literature will also be made available in lay language to the communities of origin of the participants. Authorships in the publications will be determined by the amount of scientific and academic contributions of the members of the research team, including external collaborators. There are no plans to make the data sets publicly available.IMIM on December 11, 2018. Data collection started in August 2019 and was still ongoing when the protocol was submitted (September 2020), finalizing in October 2020.The research protocol was approved by the IRB of the Data analysis began in November 2020, and it is still ongoing. The authors expect to submit the first manuscript with preliminary results by the end of 2021.From a total of 182 screened candidates, only 17 (9.3%) completed at least one self-administration trial, resulting in a total number of 64 self-administration trials. From these, 40 different substances were analyzed.It is possible to conduct an IRB-approved study using this new methodology and collect the expected data. However, the meaning and usefulness of these data are still unknown.


Citrien Fund (CF) program eHealth; 29 eHealth projects with various subjects and themes were selected, supported, and evaluated. To determine the accomplishment of the 10 deliverables for the CF program eHealth and to contribute to the theory and practice of formative evaluation of eHealth in general, a comprehensive evaluation was deemed essential.A total of 8 Dutch university hospitals are at the forefront of contributing meaningfully to a future-proof health care system. To stimulate nationwide collaboration and knowledge-sharing on the topic of evidence-based eHealth, the Dutch university hospitals joined forces from 2016 to 2019 with the first CF program eHealth were accomplished. The second aim is to evaluate the progress of the 29 eHealth projects to determine the barriers to and facilitators of the development of the CF program eHealth projects.The first aim of this study is to evaluate whether the 10 deliverables of the To achieve the first aim of this study, an evaluation study was carried out using an adapted version of the Commonwealth Scientific and Industrial Research Organization framework. A mixed methods study, consisting of a 2-part questionnaire and semistructured interviews, was conducted to analyze the second aim of the study.CF program eHealth were successfully achieved. The program yielded 22 tangible eHealth solutions, and significant knowledge on the development and use of eHealth solutions. We have learned that the patient is enthusiastic about accessing and downloading their own medical data but the physicians are more cautious. It was not always possible to implement the Dutch set of standards for interoperability, owing to a lack of information technology (IT) capacities. In addition, more attention needed to be paid to patients with low eHealth skills, and education in such cases is important. The eHealth projects’ progress aspects such as planning, IT services, and legal played an important role in the success of the 29 projects. The in-depth interviews illustrated that a novel eHealth solution should fulfill a need, that partners already having the knowledge and means to accelerate development should be involved, that clear communication with IT developers and other stakeholders is crucial, and that having a dedicated project leader with sufficient time is of utmost importance for the success of a project.The 10 deliverables of the planning, IT services, and legal played an important role in the successful progress of the projects and should therefore be closely monitored when developing novel eHealth solutions.The 8 Dutch university hospitals were able to collaborate successfully and stimulate through a bottom-up approach, nationwide eHealth development and knowledge-sharing. In total, 22 tangible eHealth solutions were developed, and significant eHealth knowledge about their development and use was shared. The eHealth projects’ progress aspects such as RR2-10.1016/j.ceh.2020.12.002 The global population is increasing rapidly, and the number of people aged ≥60 years is expected to double by 2050 ,2. The deHealth may support the necessary reforms [fragmentation of eHealth initiation [Therefore, governments are increasingly debating which health care reforms are necessary to preserve the quality of our health care system and how to effectively deliver care from a distance. The concept of  reforms . By impl reforms -8. Moreo reforms ,10. In 2 reforms . The repitiation . In addiitiation  summarizitiation . Finallyitiation . They haCitrien Fund (CF) was established for the period of 2014 to 2018 by the government-funded Netherlands Organisation for Health Research and Development (in Dutch: ZonMw). The CF aims to contribute to a sustainable health care system by stimulating collaboration between 8 Dutch university hospitals, and between the university hospitals and other health care organizations. The CF supports 5 programs with different themes [CF program eHealth, which took place from 2016 until the beginning of 2019. This first nationwide university hospital eHealth collaboration mainly focused on the constitution of a strong collaborative framework to discuss present eHealth issues, on the development of a wide array of novel eHealth solutions—with the most successful being scaled in a subsequent program—and on sharing of eHealth knowledge. The overall aim of the CF program eHealth was to accomplish 11 predefined deliverables  to evaluate the progress of the 29 eHealth projects to determine the barriers to and facilitators of the development of the CF program eHealth projects.By conducting a comprehensive evaluation of the programs -19. SubsOne coordinating Dutch Federation of University Medical Centers vision on eHealth and eHealth road map .A virtual nationwide expertise center for eHealth.International positioning by promoting in journals and media and during the closure event.Conditions for downloading medical data described and, if possible, realized.Blueprint for interoperability between hospital information systems and electronic health records.Agreements and standards for data sharing between consumer and professional eHealth.A framework for regional collaboration for effective implementation of eHealth.Models that can strengthen the empowerment of the patient.A developed multidisciplinary infrastructure to stimulate the development of digital health.Development, evaluation, and implementation of eHealth instruments in collaboration with companies and start-ups.A blueprint for education in eHealth competencies and skills for health care professionals.CF program eHealth, each project leader drafted a detailed project plan describing which of the 10 program deliverables the project aimed to contribute, the project’s objectives, and a detailed timeline. The project plan was approved by the supervising steering committee, which consisted of 2 representatives of each university hospital. In a 3-month meeting, the steering committee monitored the progress of the projects and advised the project leaders. In addition, at the midterm (December 2017) and end-term (October 2018) of the program, the project leaders presented their projects’ progress to the steering committee, and a majority decision regarding the continuation of the project was made.As described in the previous study protocol, each of the 8 Dutch university hospitals was asked to propose 3 or 4 eHealth research projects to be carried out in their own university hospital. Although the university hospitals had a carte blanche for the projects they proposed, every project had to contribute to one or more of the 10 program deliverables. In total, 29 projects covering a wide array of eHealth themes were carried out from June 2016 to January 2019 [Commonwealth Scientific and Industrial Research Organization (CSIRO) framework for evaluating telehealth trials or programs  and part two at the end-term (55 questions) for each project. With this longitudinal aspect, we aimed to evaluate the change in magnitude of the eHealth project progress over time. The topics included respondent demographics and items related to eHealth project progress aspects. The questionnaire was completed using the web-based survey software SurveyMonkey  . The resCF program eHealth, one project leader from each university hospital was randomly selected by drawing lots and interviewed by the coordinating researcher (AR) for a more in-depth exploration of the role of the eHealth project progress aspects in their project. The semistructured interviews were held by telephone, following a previously composed interview guide , but physicians were more cautious, and it was not always possible to implement the Dutch set of standards for interoperability owing to a lack of information technology (IT) capacities (deliverable 5). We also learned that considerable attention should be paid to eHealth literacy when developing novel eHealth solutions (deliverable 4). Furthermore, the establishment of alternative communication infrastructures (deliverable 9) between the caregiver within the hospital and the patient outside the hospital was investigated and considered very relevant.All 10 deliverables of the Citrien Fund - mapping table. As shown in the  outcomes or evident benefits column, in 2 of the 4 cases, personnel matters were responsible for the insufficient progress, in one case there was an issue with the intraoperability of the proposed eHealth solution with the existing IT system and in the last case there was an IT freeze hospital-wide because of the implementation of a new electronic health record system.Owing to insufficient progress, one project was prematurely terminated by the steering committee after the midterm evaluation, and another 3 projects were prematurely terminated after the end-term evaluation. These projects are indicated with an asterisk (*) in the The 2-part questionnaire was completed by all the participating project leaders in November 2017 and October 2018. The first part was completed by 29 project leaders, and the second part was completed by 27 project leaders owing to the premature termination of 1 project and the early completion of another. CF program eHealth was to receive funding . However, publicity  and collaboration  were also important reasons. Of the 29 projects, 25 (86%) had ≥3 people internally involved, and in 23 (79%) projects, people from outside the hospital, such as general practitioners, patients, and software developers, were involved as well.The main reason for participating in the planning have been presented in The main results of the questions concerning policy or organization, technology, ethics, and legal. None of the topics was spared of inconvenience, with IT services and privacy issues representing the greatest shares in moderate to significant inconvenience.finance, 8 projects  received additional funding other than that from the CF program eHealth at the initiation of the project. Furthermore, at midterm, 8 project leaders  thought that they would need extra funding for the successful completion of their project. However, at the end of the study, 13 project leaders  stated that extra funding would be necessary for project completion. The funding received from the CF program eHealth was mostly insufficient to cover the personnel expenses and the implementation aims. After termination of the CF program eHealth, of the 27 projects, 13 (48%) still needed to find financial means to continue, while 4 (15%) already had the means and 10 (37%) did not need any.Regarding the aspect of In total, 8 project leaders were interviewed, representing the entire group of project leaders. After 7 interviews, saturation of information was reached. Three major themes, with subthemes, were identified . The maiSuccess factors for eHealth development and implementationFulfill a needOutsourceCommunicationPersonnelEssential third partiesInformation technology servicesMedical Ethical CommitteeLegislationFlexibilityProject planningConducting researchEffectiveness testingneed to fulfill, or problem to solve, when developing an eHealth solution, although conducting a needs assessment was not deemed necessary. Regarding outsourcing, it was crucial to find the right  partners that already had the knowledge and means to accelerate development. Clear communication with IT developers and other stakeholders about the development and other concerns, for instance, estimated changes in routine care, was essential. Successful development of an eHealth solution may depend on the availability and dedication of the personnel, including the project leader.While carrying out their eHealth projects, the project leaders encountered several relevant aspects that contributed to the success of their projects. In such cases, there should be an evident Owing to the immaturity and complexity of eHealth, several important topics related to its development and implementation have never been discussed before. Therefore, communication and close collaboration with third parties was of utmost importance.IT services, the project leaders indicated that communication was the number one pitfall in successful collaboration. It should also be emphasized that IT development costs time, capacity, and money. Medical ethical committees may find it difficult to take a position because of the unknown impact or burden of a novel eHealth solution. Moreover, one should be informed about the impact of legislation on their project. In addition, a privacy impact assessment is often obligatory, which may cause a delay in planning.Regarding Project planning is important in the initial stages. However, it should be possible in case of incidents to make timely adjustments.eHealth solutions are considered complex interventions with multiple interacting components. This required some level of flexibility when it came down to project planning, conducting research, and effectiveness testing. conducting research, there were varying responses to whether it was challenging to find study participants to evaluate the eHealth project. However, it seems that when an eHealth solution can solve a relevant problem, patients are willing to participate. Furthermore, the study end point was difficult to determine because of the novel character of eHealth and the resulting lack of literature. eHealth solutions should be evaluated in a study context where possible. Nevertheless, it was considered unnecessary to conduct a randomized controlled trial to prove effectiveness, because, for example, patients had already experienced significant benefits while using a novel eHealth solution. In addition, while clinical effectiveness may be obligatory, it does not tell anything about the effectiveness of the eHealth solution.Regarding CF program eHealth. In this study, we learned that patients are more enthusiastic about downloading their own medical data than physicians, that the lack of IT capacities plays a negative role in implementing the Dutch set of standards for interoperability, that considerable attention should be paid to patients with lower eHealth skills, and that establishing alternative communication infrastructures between caregivers and patients should be considered very important.The evaluation study targeted the first study aim. By systematically evaluating the accomplishment of 10 program deliverables, we were able to determine the successes and lessons of the CF program eHealth.The 29 different eHealth research projects delivered 22 tangible eHealth solutions and significant knowledge about the development and use of eHealth solutions. Strengthening the patient’s directing role was the most prominent theme of the CF program eHealth was able to bring the 8 Dutch university hospitals together and therewith significantly improve the fragmented eHealth landscape in the Netherlands.Through the formation of a new collaborative network, the planning, technology, and legal played an important role in successful development of the 29 projects. However, a lack of time with the individual project leaders, priorities other than implementing eHealth in IT services, and the never discussed before privacy issues, together with the relatively short CF program eHealth duration, caused project delays.The mixed methods study targeted the second study aim. The questionnaire helped us learn that the eHealth project progress aspects success factors for eHealth development and implementation, essential third parties, and flexibility, were identified as the 3 most important themes to pay attention to when carrying out an eHealth project.In the in-depth interviews, the themes: CF program eHealth could be compared.Although it seemed that the Netherlands was among the first countries to carry out a publicly funded university hospital eHealth program, there are other nationwide eHealth programs and initiatives with which the NHS digital [CF program eHealth encompasses all university hospitals of the Netherlands. Furthermore, as described by Astana et al [CF program eHealth used a bottom-up approach to search for innovative initiatives, controlled by the 8 university hospitals rather than the government itself. Owing to the high visibility of this program on the web and the co-operation with stakeholders and patients, many useful insights into nationwide eHealth development were gathered and disseminated directly.The National Health Service (NHS), the publicly funded health care system in England, holds an active and well-organized digital section, the  digital . One of na et al , the topna et al . In contPatient@home focused on rehabilitation and monitoring services to promote patient empowerment and support treatment at home [CF program eHealth, projects may have benefited from a structured innovation model with subsequent phases of development and implementation. Especially in the case of the 4 projects that were prematurely terminated, an evaluation of the first phase of innovation—need—which includes technology screening, could have been beneficial. However, the well-thought program structure, consisting of an obligatory project plan and a planning stage at the initiation of a project and 2 project progress evaluations along the way, might have overcome the lack of a structured innovation model.The Danish program  at home . In tota at home . In the planning, technology, and legal were important aspects in relation to successful progress of the projects. From an implementation perspective, comparable results were described by Schreiweis et al [The mixed methods study found that the eHealth project progress aspects is et al . After cis et al  studied Vedlūga and Mikulskienė  compiledCF program eHealth was the open and collaborative organization with a bottom-up approach. For example, one representative from each of the 8 Dutch university hospitals took place in the steering committee and was responsible for monitoring and mentoring local projects. A solid foundation was laid for successful program progress and the achievement of program deliverables.One of the major strengths of the Another strength was the wide array of subjects and studies in the 29 eHealth projects. Although this variation may have reduced comparison possibilities and thus the external validity of projects, many valuable insights that proved important across settings were gained. However, by creating a systematic overview of the projects’ findings in the evaluation study, their comparability was greatly enhanced. The combination of an evaluation study with a mixed methods study to evaluate the progress of eHealth projects in detail further strengthens our study findings.CF program eHealth deliverables were not formulated through the well-known Specific, Measurable, Attainable, Relevant, and Timely formats. Therefore, it might be debatable whether the 10 deliverables were truly completed. Another limitation regarding the achievement of the deliverables might be the finding that most of the project leaders indicated in the questionnaire that their project planning was no longer up to date at the end of the CF program eHealth. However, a not anymore up to date project plan did not necessarily mean project failure and, therefore, its failure to achieve deliverables. Project planning was relevant to the initial direction and evaluation progress but on-time completion of project planning was not compulsory when drawing the final conclusions about the results of a project.A study limitation was that the A limitation regarding the mixed methods study might have been the number of interviewed project leaders. However, saturation of information was accomplished after 7 interviews, and the interviewed project leaders were a representative sample of the whole group.A final limitation was that we used a self-developed questionnaire to assess the eHealth project progress aspects of the 29 projects. We decided to develop a questionnaire owing to the relatively small group of participants and the limited time frame. Although valuable insights were gained, methodologically, it would have been stronger if some level of content validity and construct validity was carried out.CF program eHealth, the most successful projects have now scaled up nationwide in a subsequent edition of the CF program eHealth, focusing on implantation and upscaling [pilotitis , might also be overcome with the sequel of CF program eHealth [After termination of the pscaling . The lac eHealth .The COVID-19 pandemic has accelerated the uptake and implementation of existing eHealth solutions ,42. AlthCF program eHealth has proven that nationwide collaboration on the theme of eHealth between the 8 Dutch university hospitals and related commercial parties is possible and diminishes eHealth fragmentation. To truly preserve and improve the quality of our health care system in the light of global aging, we should strive for the elimination of eHealth fragmentation and national and international eHealth collaborations, such as the CF program eHealth, should be stimulated by governments and the European Union.The planning, technology, and legal played an important role in successful progress of the projects and should therefore be closely monitored while developing novel eHealth solutions or when implementing existing solutions. To further counteract eHealth fragmentation and take the next step from development to upscaling, a subsequent CF program eHealth will be carried out.The 8 Dutch university hospitals were able to successfully collaborate and stimulate nationwide evidence-based eHealth development using a bottom-up approach. In total, 22 novel eHealth solutions with various subjects were developed, and significant knowledge about eHealth development and use was established. The aspects


Poliomyelitis, often called polio is a viral paralytic disease caused by Polioviruses. Although all susceptible individuals are at risk of getting infected, only about 1% become paralyzed. During the 2013 Polio Outbreak in Garissa County in Kenya, 50% of the confirmed cases were from the nomadic population although it comprises of only less than 20% of the total population in the county. Following concerns from the Horn of Africa Polio Technical Advisory Group (TAG) regarding inadequate vaccine coverage of nomadic population, several strategies were put in place to improve coverage and Acute Flaccid Paralysis case reporting among nomads in the rest of the planned 2014 polio vaccination campaigns. We describe strategies initiated from April 2014 by the Ministry of Health and partners to reach children in nomadic settlement in the two sub-counties of Dadaab and Fafi of Garissa County.The strategies involved improving the mapping and tracking of the nomadic population by establishing lists of nomadic settlements obtained from local clan leaders and government administrators, their <5-year-old populations and focal persons. Focal persons were used to mobilise residents in their respective settlements and guide vaccination teams during campaigns. Settlement leaders were sensitised to report cases of Acute Flaccid Paralysis. In remote hamlets, trained community health volunteers were used as vaccinators. In such places drugs for common illness were also provided during the campaigns. A tracking tool to monitor nomadic population movement and special tally sheets to capture data were created. Training of vaccination personnel and intense social mobilisation activities was done.About 2,000 additional children, from both nomadic and non-nomadic areas were reached when the new initiatives were started. For the first time, an actual number of nomadic children accessed was documented. Suspected AFP cases continued to be reported from nomadic settlements, and the number of zero dose children among the nonpolio AFP cases dropped. With modification and improvement, these strategies may be used to take health services such as routine immunisation to nomadic communities and reduce their vulnerability to vaccine preventable disease outbreaks. Movement is within a well-defined territory, but unlike pastoralists they generally do not form permanent homes in any one place2. Pastoralists migrate periodically with their herds to maximally exploit scarce pasture and water resources which they need for their animals and themselves. Mobility is an important determinant of health worldwide, and nomadic populations in sub-Saharan Africa are no exception3. Given their lifestyle, there is inadequate systematic surveillance data on the health status of nomads. In most of sub-Saharan Africa, access to health care services by nomads is poor compared to settled populations, and there is no satisfactory strategy devised yet to deliver proper health care to remote populations. Disease control programmes also often fail to reach migratory populations7. For example, a study among the settled and nomadic Rendille in Kenya revealed that all children >12 months of age in Korr village had full immunisation coverage, while among their nomadic counterparts immunisation coverage was 0%8. In East Africa, the nomadic Turkana population was found to suffer a substantially higher infant mortality than settled Turkana agriculturalists9.More than 60% of the nomads and semi-nomads in the world live in Africa10. Despite the efforts of international organisations and national governments, immunisation coverage rates, a major indicator of health service delivery, show that in sub-Saharan Africa, nomads are inadequately accessed by the conventional health system. They also form a pool of susceptible populations where an outbreak of communicable disease can occur at any moment11. Further, nomads can be active transmitters of disease to the communities into which they move. One of the major reasons why the world’s last case of smallpox occurred in Somalia was a continual movement of the nomads and their reintroduction of the disease into the settled populations. Moreover, diseases that are thought to be under control can remain in inaccessible pockets of infection among nomads. During migration, they may transport the disease over great distances and across national boundaries12.Immunisation is one of the most successful and cost effective public health interventions. It has eradicated smallpox, lowered the global incidence of polio so far by 99% and achieved dramatic reductions in illness, disability and death from diphtheria, tetanus, whooping cough and measlesThe exact number of nomads in Kenya is not known. Apart from being highly mobile, other factors such as weak health systems, insecurity, long and unsecured porous border with Somalia, the presence of a large and highly mobile refugee population in the County and years of marginalisation have contributed to sub-optimal immunisation coverage in this part of the country. The effect has been frequent outbreaks of vaccine preventable diseases (VPDs) due to low coverage and therefore herd immunity in these hard to reach areas.11. It led to >200 cases of polio, accounting for more than half of all confirmed polio cases in the world that year12. In May 2013, a wild poliovirus type 1 (WPV 1) outbreak was confirmed in a refugee camp in Dadaab, Garissa County in North Eastern Kenya bordering Somalia. Genetic sequencing results showed that the virus was closely linked to an outbreak in Somalia that was confirmed earlier in May 2013. By July 2013, 14 cases of WPV 1 were confirmed among refugees in Dadaab and host community in Dadaab, Fafi and Hulugho sub-Counties of Garissa County. Seven out of the 14 cases were reported from the host nomadic community which comprises <20% of the residents in the County. It is important to note that only, 1% of people infected with polio become paralysed, and for every paralysed child there are approximately 200 children infected and asymptomatic around it13. This issue is significant because the actual number of people infected by polio both within the refugee camps and host nomadic community was probably very large. Shortly after, the Somali region of Ethiopia also reported an outbreak of genetically related WPV 114. Two earlier outbreaks in Dadaab Refugee Camps, a type 2 circulating vaccine derived polio virus (cVDPV2) in 2012 and WPV1 in 2006 were also importations from Somalia.In April 2013, a polio outbreak was confirmed in Banadir, South Central Somalia and quickly spread across borders to the neighbouring Ethiopia and Kenya15.Despite these outbreaks in the past, no specific strategies were designed to reach children in the nomadic population either through the routine immunisation programme or during the polio vaccination campaigns. Micro-planning for supplementary immunization activities (SIAs) focused on reaching children within urban areas and known permanent settlements, campaign coverage data was not disaggregated to show the various population sections and coverage of nomadic children was not in the post-campaign reviews agenda. The lack of specific strategies was because the nomadic population in this area was not significantly affected by the other outbreaks before the 2013 outbreak. Further, outside the outbreak period, the participation of the nomadic community in Acute Flaccid Paralysis (AFP) surveillance, one of the four strategies for polio eradication was minimal. The Horn of Africa Polio Technical Advisory Group (HOA-TAG) also expressed concern at the quality of SIAs in these areas and recommended more focus on affected areas, including improving strategies to reach nomadic and other hard to reach populationsInitiating innovative and sustainable strategies to reach these populations was therefore discussed as a priority to enhance polio eradication measures and in response to the HOA Polio TAG call. Such measures were expected to reduce the number of under or unimmunised children in the area and therefore minimising the risk of re-importation of wild poliovirus. It was also intended to bring the nomadic community into the loop of the AFP Surveillance programme to improve case reporting. Subsequently, a number of strategies were put in different areas to improve coverage among nomads. The objective of this article is to describe those interventions in the two sub-Counties designed improve mapping and tracking of the nomadic population in the two sub-Counties to reach them with polio vaccines during campaigns. These two sub-Counties were selected because six out of the seven cases reported from the nomadic population were reported here.The two sub-Counties of Dadaab and Fafi of Garissa in North eastern Kenya were identified for implementation of the new strategies. Both have long porous borders with Somalia to the East. They are host to a 300,000 - 400,000 refugee population, largely from Somalia and other Horn of Africa countries for > 20 years. Maintaining linkage to their home countries, the refugees return to the camps in Kenya after visiting their countries. Polio and other communicable diseases have been imported severally into the camps through these movement. The area is semi-arid, has poor infrastructure and security challenges. Each of the two sub-Counties is divided into three wards. To initiate the new strategies, consent was obtained from County and sub-County Ministry of Health officials, local tribal chiefs and respective government administrators.The target for the initiatives was the section of the population living in the two sub-Counties, who depending on the season, move from one location to another with their livestock and was estimated to be <20% of the combined total populations of 210,185  of the area. In 2016, the oral polio vaccine (OPV3) coverage in both sub-Counties was <80% . Three out of the five polio outbreaks between 2006 and 2014 in Kenya were reported from here.Responding to the recommendations from the Horn of Africa TAG and as part of the outbreak vaccination response, the new initiatives were implemented in the two sub Counties . These nThe nomads in this area live and travel in groups of families of a clan or sub-clan. Elders make most of the decisions touching on the lives of its members including movement and acceptance of government services. Two clans, Aulihan (in Dadaab sub-County) and Abdwak (in Fafi sub-County) live in this area. Lists of their settlements and possible watering points were to be prepared down to the lowest administrative units (sub-location) in the two subCounties to reach these families. Clan elders, water point and borehole operators and community health volunteers and government administrators in the two sub-counties were to be used for this purpose. The following information was collected for each settlement using a tracking form: location of the village, head of the family or village, the number of <5-year-old children in the settlement and available channels for social mobilisation. Before each round of polio vaccination campaign, this information on the number of settlements and their geographical locations was captured in the sub-County polio supplemental immunisation activities micro-plans.A contact person with whom the MOH could easily communicate with was identified by members of every listed settlement. These contact persons, who were invariably male, were either living in the settlements or were family members living in trading or market centres within the area and were easy to contact by MoH when required. In a few settlements, the head of the family was also the contact person. Before each vaccination round, the contact person would be contacted to give information on the actual location of nomadic family and to participate in social mobilisation for the campaign. During the campaign, the contacts are expected to guide the vaccinators to the respective settlements, while those among them who were interested were recruited as volunteers in the campaign.To reach children in settlements located far from main centres or where access was limited to motorised transport or by insecurity, community health volunteers (CHVs) drawn from the relevant clans and trained to give oral polio vaccine were sent. CHVs were also stationed at boreholes and some water points to administer the vaccine to children coming to these places with their parents after 4.00 pm when vaccinators closed work for the day.All OPV SIA teams visiting nomadic settlements or watering points also carried with them drugs used for managing common childhood illness such as diarrhoea and acute respiratory infections.All teams were provided with a special tally and summary sheets designed to capture children in nomadic settlements. At the end of each campaign, the number of children reached and their polio vaccination status was summarised by sub-County.From the start of the outbreak, attempts were made to reach out to the nomadic community to involve them in reporting suspected AFP cases. These initiatives started 8 months after the last confirmed case (July 2013) and were intended to ensure the continued participation of the nomadic population in AFP Surveillance. Experienced CHVs were assigned to each listed nomadic settlement in the two sub-counties to sensitise the identified leaders and contact persons on the lay case definition, and how to report a suspected AFP cases. Any suspected AFP case was to be reported to the nearest health facility.Data for this article are derived from the 2013-2015 polio supplementary immunisation campaign coverage and AFP Surveillance database.The total number of settlements or nomadic hamlets listed in the two sub-Counties during that process was 79 . A movement tracking form was created containing necessary details for polio campaign planning such as where settlements are located, who are the heads of the families in these settlements, the > 5 population in the settlements, details of the contacts persons for each settlement and the number of children vaccinated in the last SIA . DescripInitial vaccination responses to the outbreak followed traditional practice in the county in which focus was on reaching children in documented settlements. The first round of polio vaccination campaign using the new initiatives was implemented in April 2014. The total number of children (nomadic and urban) reached in both Sub-Counties in this round was 33,453, while the average reached in the preceding two rounds before the initiatives were 31,609. In May 2014, another round of campaign using the new initiatives was conducted . CoveragRegarding reporting of suspected AFP cases from the nomadic settlements, eight cases were reported from both sub-Counties in 2013. Four cases each were reported in 2014 and 2015 from these settlements . Of the We found that by using clan elders and other key informants in the nomadic communities, it was possible to establish a list of nomadic settlements and their location in the two sub-Counties. These settlements were then mapped and through a focal person identified for each settlement, a tracking system was established to update their movement regularly for the vaccination campaign micro-planning process.Secondly, the polio vaccination campaign coverage shows that more children, (both urban and nomadic) were reached in the April and May polio campaigns after the new set of initiatives were implemented in comparison to the average number reached before. As indicated earlier, traditional planning for routine services and SIAs was based on accessible populations living in known villages, market centres and urban areas. By involving them in the planning and implementation of the vaccination campaigns, the nomadic clans in the two sub-Counties felt recognized and comprehended their significance in the global polio eradication initiative. By implementing the new initiatives, the health management teams in the two sub-Counties also realized that their nomadic population could be accessed. The inventorying of the nomadic populations in these sub-Counties provided useful data for relief and other government services such as water development, livestock and veterinary services. Further, for the first time, campaign data for these sub-Counties were disaggregated to show the number of children reached in nomadic settlements. Not only that, reporting of suspected AFP cases from nomadic settlements continued in 2014 and 2015. Further, probably as an indication that more nomadic children were reached in the campaigns using the new strategies, all (100%) of the AFP cases reported from nomadic settlements in 2014 and 2015 had received at least a dose of Polio vaccine.The introduction of these interventions was not planned as a study but intended to improve coverage among nomadic children and get this population’s participation in AFP Surveillance. When they were first being introduced, vaccinators and supervisors were trained on the tools, and there was more scrutiny of data and data entry regarding vaccination of nomadic children. There was a lot of enthusiasm. Advocacy, communication and social mobilisation activities were intense, and records show a higher number of nomadic children reached.The limitation in this case and all cases dealing with nomads is that since an accurate size of the nomadic population is difficult to know, no list of settlements can be considered comprehensive and no number of children reached can be said to be total. Furthermore, it was possible that even with a tracking tool as was created here, nomadic families moved to another location, sometimes across the border just before or during a campaign. It was also possible that other public and private institutions working in the livestock, veterinary and water areas may have contributed additional useful information in the preparation of such initiatives. Also, the outbreak response was running for about a year, and seven rounds of campaign and awareness creation had been completed. Success may, therefore, be carried over from these efforts.15. It can, therefore, be said that to achieve any meaningful success in a community level programme, identifying and engaging its key decision makers throughout is vital. A study by UNICEF in Doolo Zone of the Ethiopia’s Somali Region in 2014 concluded that the dissemination of important messages and information is usually initiated and brokered by clan leaders and other community members of influence, including key cattle market traders and these were engaged in communicating polio related messages11.In conclusion, our observations were that more nomadic children were reached during polio SIA when; mapping and tracking of the nomadic population were improved, simple curative services were integrated into the vaccination campaign, social mobilisation activities were spearheaded by members of the nomadic communities and where necessary ‘community vaccinators’ were used. The nomadic population can also participate in AFP surveillance when the right community structures are used. In the Somali Region of Ethiopia, it was found that the involvement of nomadic community leaders before, and the integration of livestock vaccination into a polio vaccination campaign and markedly improved coverage16. We believe that the successes from the strategies used in response to this outbreak may be improved further and be a starting point to expand efforts to reach nomadic populations with critical health services. The takeaway lesson from this experience is that to maintain momentum in the implementation of such interventions, teams assigned for nomadic settlements need to be retained and retrained before each round and supervision strengthened to ensure proper data entry. As we move to attain polio free certification for polio, it is important to use the lesson learnt from this effort for routine immunisation and other vaccine preventable diseases such as Measles. Health management teams need to work closely with other sectors in order to leverage on their success in reaching all children in the area with vaccines.The Kenya Ministry of Health and its partners responded to this polio outbreak according to WHO guidelines. This requires immediate outbreak investigation, vaccination response around the cases, strengthening of AFP surveillance and enhancing routine immunisation


Both Uganda and South Africa were quick to respond to the global pandemic – Uganda for example imposing quarantine on foreign travellers after only a handful of cases before shutting off all international flights, and South Africa imposing one of the first lockdowns on the continent. Reflecting on the first 6 months of the pandemic responses in terms of refugee protection, the two countries have taken diverging pathways. South Africa used the pandemic to start building a border fence on the border with Zimbabwe, initially curtailed all foreign shop owners from opening under lockdown and excluded asylum seekers from emergency relief grants. In contrast, Uganda opened its borders to refugees from the DRC in June, when border closures were still the global norm. Whilst both responses are not unusual in light of their standard governance approaches, they highlight the own self-image the countries espouse – with Uganda positioning itself as the world’s premier refugee protector at a time when it is desperately in need of more funds and South Africa looking to politically capitalize internally from reiterating a division between migrant communities as a threat to poor and disenfranchised South Africans. Even during a pandemic, the practice of refugee protection does not happen in a political vacuum. This paper is based on over 50 in-person and digital interviews conducted in Uganda and South Africa in 2020, as well as nine focus groups with refugee and host communities. By the time the WHO officially declared the novel COVID-19 virus a pandemic – on the 11th March – both Uganda and South Africa were extremely quick to respond. On the 18th March, before a single case of the virus was confirmed in Uganda, all Ugandans and foreign nationals arriving in the country were put into a mandatory two-week quarantine with the rest of the country placed under a strict lockdown shortly after. Travellers from countries at high risk – at the time all those over 100 cases - were banned completely, for 32 days initially. In a press statement at the time president Museveni said “Foreigners going to those countries are free to do so provided they do not intend to come back within the prohibited time. We extend our sympathies to those countries and commend them for fighting on behalf of the human race”  versus cementing a positive image for the international community, not least in the wake of the elections in January 2021 (Uganda).In South Africa,  high unemployment, inequality, poverty and corruption has put the ruling party on a stress test. Exacerbated by the fact that the parliamentary majority of the ruling Africa National Congress reduced in the 2019 elections, from 61.15% in 2014 to 57.50%, making finding a scapegoat for many of the problems in the country of interest. In Uganda, the elections held in January 2021 were hotly contested, with clampdowns on politicians and journalists receiving international condemnation  – are free to move around the country, work and study as they please. Whilst this makes it one of the most generous refugee systems in the world, it is marred in practice by a lack of implementation of these regulations and an increasingly restrictive regime curtailing all these rights , under the authorities of the DHA. RROs have nationality days, which means only certain nationalities can report on certain days, already highlighting one of the unfeasibility of the current system. Pending their hearings, asylum seekers are given a temporary – so-called section 22 permit - which they have to renew every few months, but sometimes after only a few weeks. Under the new regulations, asylum claims are considered to be ‘abandoned’ if the section 22 permits are not renewed for more than 30 days, leaving asylum seekers subject to deportation potentially at the cost of violating Since there are limited opportunities for low-skilled migrant workers to live in South Africa legally, many look for other ways to regulate their stay, including through a section 22 asylum permit. This misuse of the asylum system by economic migrants is often highlighted by the government as the cause of inefficiencies and the insurmountable backlog in processing , and they get prima facie refugee status under the Organisation of African Union Refugee Convention of 1969. Other refugees – like from Burundi, Rwanda or Eritrea – have to go claim for asylum and thus go through the formal status determination procedures. Uganda has long adopted a development approach towards refugees, whereby they aim to make the refugee population less dependent on humanitarian aid in the long run, as well as incorporate the host population in a more integrative development approach. This has been pursued by a variety of approaches, including the Self-Reliance Strategy (from 1999); the Development Assistance to Refuge-Hosting Areas Programme (2004) and the Settlement Transformative Agenda launched in 2015. The Transformative Agenda underpinned that Uganda was pursuing a non-encampment approach and that refugees are part of the broader development agenda of the country. In the same year, refugees were included in the National Development Plan II (NDP) and the ReHoPE Strategic Framework was introduced. This brought in a “30–70” principle, whereby at least 30% of all interventions for refugees should target host-community needs.Finally, as a follow-up to the New York Declaration of Refugees and Migrants, the Comprehensive Refugee Response Framework (CRRF), incorporated into the Global Compact on Refugees, was launched in 2017. A multi-stakeholder coordination model on refugee matters focusing on humanitarian and development needs of both refugees and host communities, the CRRF was introduced in Uganda, Ethiopia, Rwanda and Kenya as pilot studies. The “whole of society approach” endorsed by the CRRF, is “based on the Ugandan model”  image as a refugee-friendly country of ‘open doors’ is also necessary in order to address their funding gap . Access continued the usual pattern of excluding migrants and asylum seekers from state benefits at a time when they were equally affected by the pandemic. Only refugees with section 24 permits and permanent residents were eligible to receive the COVID-19 SRD grant. It took a court decision on 18th June 2020 for the government to cater for asylum seekers with section 22 permits and migrants from Zimbabwe, Lesotho and Angola on Special permits.Moreover, asylum seekers depend on their permits for everything, including banking, being able to attend school and working. They can only get their permits from the RROs. But some of these refugee reception offices already stopped providing their services even before the announcement of the lockdown, arguing that they needed to receive personal protective equipment (PPE) first Bornman, . The depThere has also been a noticeable tendency of trying to use the pandemic as an opportunity to implement already-aspired for exclusionary policies that serve domestic interests.While outlining her ministry’s response to the state of disaster at the beginning of the first wave, the Minister of Small Business Development, Khumbudzo Ntshavheni specified that, only South African owned and operated spaza shops were allowed to open during the lockdown. Spaza shops are small informal food stores found in township areas. Estimates count up to 100,000 across South Africa, with the majority run by migrants and refugees. As a result of this pronouncement, migrant-operated spaza shops were being forcibly shutdown by police on the first day of lockdown in some parts of the country .Whilst on March 25th 2020, the government officially closed the asylum space, Uganda made international headlines in July, by temporarily suspending the border closures to allow entry of refugees from DRC stranded close to the border. This opening in the middle of a pandemic was no doubt a difficult decision due to the public health ramifications it could hold. These fears were exacerbated by the fact that DRC and South Sudan, the major sources of refugees to Uganda, though hard hit by the pandemic did not have in place measures to contain the pandemic as compared to Uganda.Nevertheless, on 1st July 2020, Uganda temporarily re-opened two border crossing points, in Gulajo and Mount Zeu in Zombo district, to asylum-seekers from the DRC. These were part of a larger group of over 45,000 people who had attempted to flee towards the Ugandan border with the DRC shortly after deadly militia attacks on civilians in Ituri province on 17th and 18th May 2020. According to the UNHCR, between 1 and 3 July, 3056 people entered Uganda, with children accounting for 65% percent of the group UNHCR, . After aThough applauded for having a very favourable policy towards refugees and asylum seekers, with the pandemic wreaking havoc globally, the country found itself in an uncertain situation. At the very least, the move reiterated the positive image of the country, and therefore was a “diplomatic coup”  for the country, in dire need for new funds. Funding shortfalls and the disruption of global supply chains for relief food has negatively impacted refugee communities. As previously noted, as of July 2020, Uganda had only 22% of the funding it needs to carry out its operations for the year UNHCR, . Due to In addition to the direct cut in aid, the social economic impact of the pandemic takes a heavy toll on refugees. Particularly affected are the urban refugees, because the majority are employed within the informal sector with limited access to social protection, safety nets and are outside the scope of fiscal measures to stimulate the economy, which do not address the informal sector. In addition, Standard Operation Procedures to counter the pandemic have increased the cost of doing business because the onus is on business owners to put in place facilities for hand washing, temperature guns as well as ensure and enforce social distancing in their areas of operation. Not only are the handwashing facilities difficult to come by, but restrictions on mass gatherings are hindering their access to markets and informal sector work. Social distancing measures are cutting refugees off crowded spaces such as markets and streets forcing them to look for alternative spaces for doing business. Lockdown measures did not have a homogeneous impact on food access across the country. While in Kampala the food markets remained open and even had surplus food, in Arua there was an overall reduction in the food supply which resulted in the inflation of food market prices . Indirectly, refugees have also been affected as enterprises have laid off workers who have returned to their home regions and reclaimed their land from the refugees for own use.Measures aimed at economic empowerment of refugees remain limited. While several economic stimulus measures have been proposed by development partners such as the European Union, the World Bank and the International Monetary Fund, these are targeting business owners and are not specific to refugees. The new EU fund, see above, was yet to materialize and start implementation at the time of writing.Social protection, especially social assistance, remains uncertain for refugees in both settlements and urban areas. A reprioritisation of humanitarian assistance amidst funding short falls, has left refugees in a particularly precarious situation during the COVID-19 pandemic.COVID-19 in Uganda is shrouded in misbelief about its existence, effects and treatment. Until today, there is a section of the population that questions the existence of COVID-19 in the country, with support mainly observed on social media platforms Amuge, . The popMoreover, enhancing the mobility of District Security Officers instead of health teams and inaction on truck drivers carrying cargo into the country as the main importers of the virus into the country was further evidence of government misplaced priorities in the COVID-19 response. This was not helped by the large appetite for borrowable funds from international financial institutions. With a history of financial misappropriations, the population was not convinced of the government’s intentions  or to flatten the curve after the first wave of infections (South Africa). Lockdown measures by and large aimed at protecting the population especially the most vulnerable ones from the pandemic. However, lockdown measures were also sometimes used to as an opportunity to pass restrictive policies on people’s rights and freedoms. No wonder therefore that some of the population in both countries remained ambivalent of the measures put in place to control COVID-19.There are also many differences between the countries. The different economic strengths of the two countries for example also shows in its pandemic response. Direct relief packages were available in South Africa – albeit belatedly for asylum seekers. This was not an option in Uganda, for anyone.Uganda was quick to shut off all international travel – before officially recording their first case. It is of course much easier to do so, considering that the country has only ten entry points – including only one international airport – whereas South Africa has 72, including ten airports that serve as points of entry to the country. In South Africa, the focus seemed to be on stopping regional migration, though this was not supported by public health arguments, with the country having far more COVID-19 cases than its neighbouring countries. In Uganda, this was less of an issue – borders were even formally opened as discussed - though there were also concerns with truck drivers as potential vectors of the virus. The population remained suspicious of the government intentions- putting the economic goals over population’s health.Moreover, both countries have their own specific characteristics of refugee protection, which are mirrored in their pandemic responses. In South Africa, there is a state-led bureaucratized merging of refugees and migrants, in the shadow of institutionalized xenophobia leading to increasing securitisation. During the pandemic, the response has been a securitized approach towards regional land borders, limited access to social protection measures for asylum seekers and several cases of xenophobic political rhetoric. The Ugandan system, though unique in size and approach, is characterised by an overtly centralised system prone to local conflicts and with a dependency on external donors. Uganda’s response, though quick and decisive, by restricting movement and social interactions, has negatively impacted the social protection for refugees. Moreover, the opening of its borders during the pandemic highlighted the generosity of their approach whilst reiterating their problematic funding gaps.Broadly speaking, the pandemic responses towards asylum seekers and refugees align with wider goals of the two countries – gaining legitimacy from a frustrated public (South Africa) versus cementing a positive image for the international community in the wake of the 2021 elections (Uganda). In South Africa, the ruling party has received much criticism for the COVID-19 response, which has thrown millions of South Africans to the economic brink, in what was already a fragile situation. Corruption, poverty and inequality have long led to scapegoating of migrant communities in order to gain political leverage domestically (Moyo & Zanker, Uganda on the other hand has much to gain from the positive image of refugee protection, in what has become a not always easy relationship to their humanitarian and development partners (see also Hovil, In sum, the pandemic responses speak to internal – South Africa – and external – Uganda- political gains. Of course, the South African government is also concerned with their external image, just as much as the Ugandan government is with their own voting populace. South Africa has received condemnation for not better controlling the outbreaks of xenophobia, including the recalling of the Nigerian ambassador in 2019 (Chigumadzi,