Delivering an Innovative Multi-disease Screening Tool to High-risk Migrant Populations
Phase: NA
Conditions: Hiv, Hepatitis B, Hepatitis C, Tuberculosis, Chagas Disease, Schistosomiasis, Strongyloidiasis, Female Genital Mutilation Type I Status, Female Genital Mutilation Type II Status, Female Genital Mutilation Type III Status
Sponsor: Barcelona Institute for Global Health

 
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Research protocol title: Delivering an Innovative Multi-disease Screening and Vaccination Tool to High-
risk Migrant Populations (ISMiHealth)  
Promoter: Barcelona Institute for Global Health (ISGlobal)  
Principal investigator: Ana Requena Méndez  
Address: Carrer Roselló 132, 4 08035, Barcelona  
Co-Investigators:  
 
Angeline Cruz  
Stella Evangelidou  
Ethel Sequeira  
Alessandra Queiroga  
Ermengol Coma  
Carina Aguilar  
Laura Medina  
Angela Martinez  
Elisabet Ferrer  
Joaquín Salas  
José Vázquez  
Nicolás Piqueras  
María Pilar Luzón  
María del Pilar Requena  
Silvia Vallejo  
Marta Vázquez  
   Constanza Jacques Avino  
Alba Cuxart 
Setting: Primary care centres in Catalonia and Andalusia  
Version: 8.0   
Date: October 10, 2024  
 
 

 
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RESEARCH PROTOCOL  
1. JUSTIFICATION  
Migration is a significant, complex, and growing global phenomenon of critical importance to European 
countries1. Having good health is key for a smooth and prompt integration process into the host 
community2. However, heterogeneous socio-economic, cultural, and legal factors across European 
countries affect migrants' physical and psychological health and determine the availability, accessibility, 
acceptability, and quality of services in the new host environment3. Unprecedented rises in migration 
to and within the European Union (EU) in recent years have resulted in numerous challenges for health 
services4; also, in Spain where the foreign population represented in July 2020 11.2% of the total Spanish 
population5. The need for integrated programmes to deliver effective and cost-effective services to high-
risk migrants is now a key step for the medical services within the EU6.  
Migrants may have particular health needs; they are disproportionately affected by key infections, 
including tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis 
C virus (HCV) in Europe; and this has been associated with the incidence in the country of origin, socio-
economic risk factors and other comorbidities on arrival to the host Europe7. A decline in TB incidence 
in most European countries in recent decades has slowed due to the re-emergence of TB in vulnerable 
populations, including migrants7. Overall, approximately 33% of TB cases in the EU were foreign-born in 
2016 but there is considerable variation between countries8. In 2018, almost half of the new HIV cases 
(42%) within the EU occurred in the migrant population9and hepatitis B and C prevalence in migrants in 
Europe is estimated to be 6 and 2 times higher, respectively, than the general population10. In addition, 
a homogeneous strategy in European countries including Spain on vaccines and preventable diseases 
in migrant adult populations is still lacking11. And this will be particularly crucial for the COVID-19 vaccine 
strategy to elucidate if the national strategy will also explicitly include asylum seekers, refugees and 
undocumented migrants who should not be left behind in the fight against the COVID-1912, but also to 
evaluate how the vaccination records will be registered and traced in the migrant mobile population. 
Similarly, certain imported diseases, only prevalent in migrant populations13-16, are at risk of 
transmission in non-endemic areas under special circumstances (through transplants, blood-transfusion 
or congenitally)15 and are potentially severe, particularly if there is a diagnosis delay, in 
immunosuppressed patients16.  Finally, female genital mutilation is a neglected condition, with 
estimates about 38000 migrant women in some European countries17. In Spain, a study reported a 
profound lack of knowledge around the concept, typology, countries with a high prevalence of female 
genital mutilation and protocols of action for health professionals, who are then unable to identify and 
detect risk factors18.  
Health systems need to be prepared to respond to both immediate and long-term health needs of 
migrants with an inter and multidisciplinary approach, considering the migrants' backgrounds and the 
impacts of poverty and gender on health. The need for integrated programmes to deliver more effective 
and cost-effective services to high-risk migrants is now a key step for the medical services within 
European countries6.  
Accordingly, health systems are responsible for providing an efficient, economic, and affordable solution 
to be implemented at primary care and hospital level. However, primary care is usually the first contact 
point of the migrant population with the health system and therefore, these health facilities are key to 
guarantee the early detection of migrant health needs. It should be added post-migration transmission 
and complications of communicable diseases and other conditions prevalent in migrants could be 
prevented or reduced by enhanced screening and vaccination strategies focused on migrant 
populations19.   
Screening and vaccination policies may improve the communicable diseases and the female genital 
mutilation prevention, diagnosis, and treatment if the legal and policy environment is conductive. 
Screening all of these conditions may be beneficial either because there is a transmission risk through 

 
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community exposure, transplants, blood transfusion or congenitally or because severe complications and 
sequel may be prevented if the diseases are early identified6.   
Data on cost-effectiveness are scarce but suggest moderate to high cost-effectiveness of migrant 
screening programmes depending on the migrant group and disease targeted. Cost effectiveness 
studies evaluating screening for TB in migrant populations have shown a clear benefit of screening 
among high prevalence groups, close contacts of those with known TB, and migrants at entry if they 
originate from intermediate- or high-TB-incidence countries defined as >60/100000 and >120/100000, 
respectively11. These studies demonstrated that increased cost-effectiveness was associated with higher 
TB incidence in the country of origin, suggesting that programmes will be more cost-effective when 
targeting migrants from countries of origin with a high incidence TB. However, most TB screening 
programmes in Europe target asylum seekers and refugees and, therefore, miss other circulating migrant 
groups11 that could be potentially targeted in other settings such as primary care. In addition, the average 
cost per patient of TB in Spain has been estimated to be 10,262€, with an estimation of the total cost in 
Spain during 2016 of around 40 million€20. This cost increases significantly when associated with patient 
admission and could be potentially everted if proper measures are established to improve the early 
detection of the disease.  
Approaches such as moving from routine HIV testing from sexual health and antenatal clinics to non-
traditional settings (e.g., primary care) to reduce the pool of undiagnosed HIV infections in the 
population have been recommended21. A recent health economics analysis has demonstrated that HIV 
screening in primary care in high HIV prevalence areas is cost effective22 and pilot studies have 
demonstrated the feasibility and acceptability of implementing routine HIV and other communicable 
diseases screening tests among patients and healthcare professionals in primary care. Implementation 
of targeted HBV and HCV screening programmes to increase early diagnosis and treatment is important 
to reduce the burden of chronic hepatitis B and C among migrants23, which has also been demonstrated 
for Chagas disease24.  
The new guidelines from the European Centre for Disease Control and Prevention11 on infectious 
diseases screening and vaccination in new-arriving migrant populations and alongside country-specific 
guidelines, promote screening implementation at the primary care level25. In particular, ECDC guidelines 
call for innovative approaches to multi-disease testing and vaccination in high-risk migrants11. 
Nevertheless, how best to implement these new guidelines is not clear and there is an urgent need to 
explore country-specific implementation to assess effectiveness and cost-effectiveness6.  
Current migrant screening programmes across Europe are too narrow in focus, focusing mainly on active 
TB and mainly on asylum seekers and refugees6. Also, recommendations are often expert-opinion driven 
and rarely evidence-informed. In general, comparison of these strategies across countries or regions has 
been performed for single diseases, such as TB or hepatitis, but not comprehensively across all relevant 
conditions. In addition, the implementation of screening programmes requires coordination between 
health care providers, social services and policymakers and should include insights from diverse 
disciplines (Economics, Epidemiology, Clinical Practice, Psychology or Social science)6. In this regard, the 
need for integrated programs of migrant health care, including screening and vaccination programmes, 
has introduced a challenge to medical services within the EU19.  
The current value of a systematic screening at primary care level has not been properly evaluated and 
the practical implementation of screening programmes remains a challenge at primary care level6, 
particularly when including imported diseases. In this regard, one of the  main determinants of barriers 
that delay and decrease the detection rate of communicable  diseases, generate health inequalities, 
increase morbidity and DALYs associated, and also  increase the risk of transmission of disease within 
migrant communities is the lack of expertise  of health professionals in assessing the risk of 
communicable diseases and other conditions  in migrants including the epidemiological risk considering 
their individual differences (sex, age, epidemiological origin)18. This may combine to affect health 
outcomes of migrants, generating health inequities and sustaining disease transmission, and 

 
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consequently increasing the cost for health systems. Although migrant screening guidelines are 
becoming increasingly available, most of the screening strategies designed require the health 
professionals´ active commitment to navigate much deeper into the guidance until finding the 
epidemiological information on the country of origin that is needed for the individual-based risk 
assessment to take the appropriate screening decision. In many cases, guidelines do not provide specific 
information by country of origin and a general recommendation is provided considering all migrants 
as a homogeneous group. Therefore, in many settings, the screening programme is overestimating the 
population at risk, thereby wasting the scarce health resources of the health system - for example, low 
prevalence of HBV and HCV in most Latin American countries would not justify screening of these 
infections to migrants coming from these countries.   
With the aim of improving patient care by strengthening medical decisions, there has been an 
outstanding development of clinical decision support systems in the last decade26. In such tools, the 
characteristics of an individual patient are matched to a computerized clinical staff knowledge base in 
patient-specific assessments and recommendations are then presented in electronic patient record (EPR) 
system to the clinical staff for decision. The decrease in consultation time, wrong diagnosis, and test 
duplication at primary care settings support the cost-effectiveness of implementing CDSS in screening27.  
Our research group has already developed an innovative prototype digital software (CRIBMI)28. This 
user-friendly and simple software was designed by the Barcelona Institute for Global Health (ISGlobal) in 
collaboration with the Jordi Gol Institute for Primary Care Research (IDIAP Jordi Gol) and the Fundació 
Clinic Recerca Biomédica (FCRB) and was tested in four primary care centres (PCCs) in Catalonia. In 
addition, this software was already integrated into the EPR system in Catalonia at primary care level 
(eCAP). The software uses routinely structured health data (country of origin, sex, and age) collected by 
the administrative staff of the health centre and registered in the EPR system, and through simple 
algorithms, generates an automated screening decision support system able to inform clinicians about 
screening on targeted conditions in migrants based on an individual risk- assessment. It currently 
includes eight conditions: 7 communicable diseases (HIV, HBV, HCV, TB, Chagas diseases, strongyloidiasis 
and schistosomiasis) and one key health condition (female genital mutilation)29. Data shows the digital 
tool is feasible to implement, acceptable to healthcare professionals and migrants, and well adapted to 
the primary care context30, with data suggesting that the digital tool is improving the diagnosis of 
imported conditions but also other common communicable diseases in migrants when comparing it with 
a standard training programme30.  
The aim of this study is to implement and test a digital tool that will use routine health data to perform 
an individualized risk assessment (using a set of parameters: age, sex, country of origin) and it will 
provide recommendations for primary care health professionals in several health aspects: the screening 
of communicable diseases and female genital mutilation. This can better utilize scarce health care 
resources and at the same time, improve the knowledge of health professionals on migrant health 
conditions. 
BIBLIOGRAPHY  
1. Willekens F, et al. International migration under the microscope. Science (80- ).  
2016;352(6288):897 -9.  
2. OECD. Working Together for Local Integration of Migrants and Refugees. Working Together for Local 
Integration of Migrants and Refugees. 2018.  
3. Bradby H, et al. Public health aspects of migrant health: a review of the evidence on health status 
for refugees and asylum seekers in the European Region. Copenhagen: WHO Regional Office for 
Europe, Health Evidence Network synthesis report. 2015.  
4. MINISTERO DELL´INTERNO. Study Group on the reception system. Report on the reception of 
migrants and refugees in Italy. Aspects, procedures, problems. Rome; 2015.  

 
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5. Instituto Nacional de Estadística. Cifra de población. Provisionales a 1 de Julio 2020.   
6. Seedat F, et al How effective are approaches to migrant screening for infectious diseases in Europe? 
A systematic review. Lancet Infect Dis [Internet]. 2018;18(9):e259 -71.   
7. European Centre for Disease Prevention and Control (ECDC). Assessing the burden of key infectious 
diseases affecting migrant populations in the EU/EEA. Stockholm. 2014.  doi:10.2900/28792. 2014.  
8. Lönnroth K, et al. Tuberculosis in migrants in low-incidence countries: Epidemiology and 
intervention entry points. Int J Tuberc Lung Dis. 2017;21(6):624 -36.  
9. European Centre for Disease Prevention and Control (ECDC), World Health Organization (WHO). 
HIV/AIDS surveillance in Europe 2019 - data 2018. 2019.  
10. Hahné SJM, et al. Infection with hepatitis B and C virus in Europe: A systematic review of prevalence 
and cost-effectiveness of screening. BMC Infect Dis. 2013;13(1).  
11. European Centre for Disease Prevention and Control (ECDC). Public health guidance on screening and 
vaccination for infectious diseases in newly arrived migrants within the EU/EEA. 2018.  
12. Mukumbang F. Are asylum seekers, refugees and foreign migrants considered in the COVID-
19 vaccine discourse?. BMJ Glob Health. 2020; 5(11): e004085.  
13. Asundi A, et al. Prevalence of strongyloidiasis and schistosomiasis among migrants: a systematic 
review and meta-analysis. Lancet Glob Heal 2019;7(2):e236 -48.   
14. Requena-Méndez A, et al. Prevalence of Chagas Disease in Latin-American Migrants Living in Europe: 
A Systematic Review and Meta-analysis. PLoS Negl Trop Dis. 2015;9(2):1 - 15.  
15. Requena-Méndez A, et al. Health Policies to Control Chagas disease transmission in European 
Countries. PLoS Negl Trop Dis. 2014;8(10).  
16. Requena-Méndez A, et al. Evidence-based guidelines for screening and management of 
strongyloidiasis in non-endemic countries. Am J Trop Med Hyg. 2017;97(3):645 -52.  
17. Jordal M, et al. Challenges in providing quality care for women with female genital cutting in Sweden 
- A literature review. Sex Reprod Healthc [Internet]. 2018;17(September 2017):91 -6. Available   
from: https://doi.org/10.1016/j.srhc.2018.07.002  
18. González-Timoneda A, et al. Knowledge, attitudes and practices of primary healthcare 
professionals to female genital mutilation in Valencia, Spain: Are we ready for this challenge? BMC 
Health Serv Res. 2018;18(1):1 -13.  
19. Gushulak B, et al. Migrants and emerging public health issues in a globalized world: threats, risks and 
challenges, an evidence-based framework. Emerg Health Threats J.  2010;2: e10.  
20. Gullón JA, et al. Tuberculosis Costs in Spain and Related Factors. Arch Bronconeumol 
2016;52(12):583 -9.   
21. Leber W, et al. Effectiveness and cost-effectiveness of implementing HIV testing in primary care in 
East London: Protocol for an interrupted time series analysis. BMJ Open.  2017;7(12):1 -8.  
22. Baggaley RF et al. Cost-effectiveness of screening for HIV in primary care: a health 
economics modelling analysis. Lancet HIV. 2017;4:e465 -74.  
23. Suijkerbuijk AWM, et al. Cost-effectiveness of screening for chronic hepatitis B and C among migrant 
populations in a low endemic country. PLoS One. 2018;13(11):1 -16.  
24. Requena-Méndez A, et al. Cost-effectiveness of Chagas disease screening in Latin America migrants 
at primary health-care centres in Europe: a Markov model analysis. Lancet Glob Heal. 2017;5(4):e439 -
47.  
25. Public Health England. Migrant health guide. Available from:   
www.gov.uk/government/organisations/public-health-england  
26. Van Dort BA, et al. Optimizing clinical decision support alerts in electronic medical records:  a 

 
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systematic review of reported strategies adopted by hospitals. J Am Med Informatics Assoc 2020. 2021 
Jan 15;28(1):177-183.  
27. Sutton RT, et al. An overview of clinical decision support systems: benefits, risks, and strategies 
for success. npj Digit. Med. 2020;6;3(1):17.  
28. Requena-Méndez A. Migrant Health Conference -ISTM. In: CRIBMI: Improving screening 
strategies for migrants in Primary Care (PC). 2018.  
29. Sequeira-Aymar E, et al. Recommendations for the screening for infectious diseases, mental 
health, and female genital mutilation in immigrant patients seen in Primary Care. Aten Prim 
2020;52(3):193 -205.  
30. Sequeira-Aymar E, Cruz A, Serra-Burriel M, di Lollo X, Gonçalves AQ, Camps-Vilà L, et al.  Improving 
the detection of infectious diseases in at-risk migrants with an innovative integrated multi-infection 
screening digital decision support tool (IS-MiHealth) in primary care: A pilot cluster-randomized 
controlled trial. J Travel Med. 2021;1–11.   
2. HYPOTHESIS  
Screening programmes for migrant-related diseases differ widely, and detailed descriptions of their 
effectiveness are currently lacking. Comprehensive data on the design and performance of screening 
programmes for both communicable diseases and female genital mutilation in migrant groups in Spain 
would enable opportunities for cross-regional sharing of information and homogenizing best practice.   
Our hypothesis is that migrants´ overall health status may be improved by increasing the detection of 
certain infectious diseases and other conditions for which effective care is available. This can be achieved 
through a systematic screening of these conditions that can be facilitated by using innovative and digital 
solutions implemented in the routine health care. 
3. OBJECTIVES  
General objective: To develop an integrated and primary care based, communicable diseases and female 
genital mutilation screening programme for migrant populations in Spain in order to promote better 
health and integration.  
Specific objectives:  
Aim 1: To develop a Spanish consensus guidance on migrant screening recommendations based on 
existing European examination/screening programmes and on a consensus of a country-expert 
transdisciplinary national collaborative network.  
Aim 2: To scale-up and validate a simple and user-friendly innovative digital tool that will be integrated 
into the local electronic patient record system of primary care in two different settings (Catalonia and 
Andalusia) and that aims to facilitate targeted screening to recently arrived migrants presenting for a 
routine appointment. This digital tool will support health professionals to follow best-practice 
recommendations; while considering patients' individual characteristics (country of origin, age, sex) and 
therefore specific risk factors.  
4. STUDY DESIGN  
This study will be developed into two sub-studies in order to accomplish the specific objectives.  
4.1.1 Study 1 related to aim 1. Spanish consensus guidance on migrant screening recommendations  
a. A comparative review and analysis of existing screening programmes will be performed 
across Catalonia and Andalusia. We will comprehensively review screening policies for migrants and the 

 
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access to these programmes in Spain, including: health care settings, type of migrants (asylum 
seekers/refugees/undocumented), diseases included, gender perspective (specific programmes for 
women), target higher-risk subgroups (e.g., immunosuppressed), access to treatment and follow-up 
(particularly for female genital mutilation) and inter-disciplinarity of the programmes.  
b. A survey on migrant health screening strategies policies for migrants will be conducted 
targeting national experts to (i) assess what screening strategies for migrant on infectious diseases and 
female genital mutilation are being implemented; (ii) to provide the contact details from their National 
Ministry of Health experts, responsible of asylum seekers programmes, blood banks, national transplant 
organizations, and antenatal care units of Spain.   
c. A report with the reviewed results will be developed and presented in two consensus 
workshops, one in Catalonia and one in Andalusia.  
d. A consensus workshop with national experts will be carried out to establish which diseases 
will be included in the final screening algorithm and what will be defined as the screening criteria for 
each condition. The tentative elements to include are HIV, HBV, HCV, TB, selected parasitic infections 
and female genital mutilation. For most of the communicable diseases, the screening criteria will be fully 
aligned with the current ECDC screening guidelines and recommendations. The screening criteria used 
in the previous project (CRIBMI) will be reviewed and updated. In the previous project, HIV test was 
offered following ECDC recommendations to those individuals coming from countries with a prevalence 
>1%. HBV and HCV tests were offered (also following ECDC guidelines) to those individuals coming from 
countries with >2% prevalence. Strongyloidiasis and schistosomiasis tests were offered to those 
individuals coming from endemic areas, also defined in the ECDC guidelines. Chagas disease test was 
offered to those individuals coming from the 17 Chagas endemic countries. Nevertheless, active TB was 
screened in migrants from countries with an incidence >50/100000. Furthermore, exploring the risk of 
female genital mutilation was considered in all women between 15 and 50 age years-old that come from 
countries where this practice is frequent.   
e. To measure the level of agreement with the recommendations a questionnaire based on a 
Linkert Scale of 5 points (1- Strongly disagree, 2- Disagree, 3- Neutral, 4- Agree and 5- Strongly agree) will 
be sent to the different experts invited to the workshops. The agreed recommendations by setting can 
be found in the supplementary files, Annex 1 for Catalonia’s recommendations and Annex 2 for 
Andalusia’s recommendations. 
4.1.2 Study 2 related to aim 2. Operational implementation of a pilot screening programme using the 
ISMiHealth software and evaluation of its feasibility, impact, equity, and cost. The study will be registered 
in clinical.trials.gov  
a. Study design and subjects.   
A pragmatic cluster controlled randomised trial will be conducted in 41 PCCs of Catalonia and 
Andalusia to explore and assess the effectiveness of the digital tool ISMiHealth. In Catalonia, 35 PCCs will 
compose the sample size (see sample calculation below) and in Andalusia 7 centres will be selected to 
conduct the pilot study. See Annex 3 and 4 for the list of the participating centres. Eligible participants 
will be Health professionals working at the corresponding PCCs. Indirect participants will be migrant 
populations attended at Primary care (aged >14 years in Andalucía and >15 years in Catalonia), included 
in the definition of the targeted migrant population (people coming from countries in the geographic 
areas of Africa, Latin-America, Asia and Eastern Europe following the categorization of the UN Statistical 
Commission), that are attending the PCCs for any reason. No exclusion criteria will be set concerning the 
year of arrival to provide the screening recommendations except for active TB where a limit of five years 
since the arrival to the host country will be established. These criteria will be established since all the 
infections, except for active tuberculosis, are chronic infections and because a higher risk of such 
infections has also been seen in long term migrants.   

 
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b. Health centres selection, randomisation and masking.  
Regarding the selection of the participating PCCs in Catalonia, the IDIAPJGol research team will 
find areas where there are referents with an interest in participating in the study. The list of PCCs 
belonging to these areas, where the referral to the reference laboratory is more feasible, will be 
provided. With this final list, we will proceed with the randomization stratified by area and by density of 
migrant population in the area (low, medium and high). For the selection of the PCCs in Andalusia, an IT 
committee of the Andalusian Health Service (SAS) will provide a list of the possible centres that could 
participate in the study and the randomization will be carried using the same stratification method 
mentioned previously. The randomization will be performed through a statistical software for each pair 
of selected health centres stratified by study area. Therefore, for each pair of PCCs, one PCC will be 
randomly selected to implement the screening programme through the ISMiHealth software, and it will 
be compared with the other PCC of the same area where the PCCs do follow the current practices in the 
routine care. However, one of the seven centres will not be paired, but will participate of the 
intervention. In both cases, health professionals will receive a training session on migrant health; the 
training contents will include for each condition, epidemiological aspects, diagnosis, treatment and the 
screening recommendation.  
In addition, a group informed consent will be required to be signed by the Director or a responsible of 
each PCC where they will agree that their respective PCC will participate in the study. 
c. Implementation strategy.   
The implementation strategy designed will be carried out in three phases and using mixed 
methodology. For the study of the implementation process, three PCCs, per study setting (3 in Catalonia 
and 3 in Andalusia) will be selected by convenience from the intervention branch. In the pre-
implementation phase, the local needs, resources, barriers, and facilitators will be assessed through the 
conduction of focus group (FG) discussions for professionals and the migrant population, with the aim of 
adapting the intervention to the contexts of each setting. FGs for professionals and migrants will be 
carried out separately. In the implementation phase, real-time monitoring of the strategy will be 
performed (by a data manager and a study coordinator from each PCC) in order to identify opportunities 
for improvement and optimization of the process.  The technical monitoring will help identify errors in 
the implementation of the alerts in the EPR system, to be mitigated in real-time. In the post-
implementation phase, participants´ opinions will be assessed through FG discussions and in-depth 
individual interviews (IDI) with health professionals, IDI with intervention PCC’s directors, IDI with 
managers of the health care system, and IDI with migrant patients who have undergone any of the 
included screening tests during the study period. We aim to understand the vision of professionals 
participating in the intervention on aspects of utility, applicability, understanding and relevance of the 
alert system, as well as barriers and facilitators for the implementation of the alert system in the health 
information systems to the entire health care systems (Catalan Institute of Health and SAS). We also aim 
to understand the opinion of migrants regarding screening and referrals pathways derived from health 
care. Approximately 10 FGs and IDI will be conducted with health professionals, around 10 IDI will be 
done with PCC’s directors/managers and up to 40 IDI will be carried out with migrant patients. These FG 
discussions and IDI will be carried out in the corresponding PCC and will last approximately 90 and 60 
minutes respectively. Quantitative indicators will also be taken to evaluate the outcomes of the 
implementation. Additionally, an ad-hoc survey of the programme acceptance, targeting health 
professionals and a sample of migrants will be performed.  
 
d. Two sub-studies regarding the topics of i) Female Genital Mutilation (see Annex 5) 
and ii) Health Data Collection (see Annex 6) will be carried out.  
5. INTERVENTION  
The implementation of the screening programme will be facilitated using a simple and user-friendly tool 

 
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that helps health professionals to follow best-practice recommendations while taking into account 
patients' individual characteristics: country of origin, age, sex. ISMiHealth set a series of rules that 
provide real-time prompts to health professionals on screening of infectious diseases and female genital 
mutilation for migrants.  
In Catalonia, the digital tool has already been integrated to the EPR system (e-CAP), program shared by 
all PCCs that are part of the Catalan Institute of Health, as part of a pilot study. The 3 demographic 
variables (country of origin, age and sex) are routinely collected by the PCC´s administrative staff and 
documented in electronic medical records. Once the administrator collects these variables in the 
computer system, the tool will generate an alert that will be reflected once the patient’s medical history 
is reopened. Therefore, when the migrant patient goes to the consultation with the health professional, 
the alert will appear containing the recommendations for screening of the different diseases/conditions. 
The data of the patients is not registered nor collected by the digital tool, it is only used to produce the 
alert.  
In Andalusia, the digital tool will be integrated for the first time into the primary care EPR system 
(DIRAYA). Similar to what is described above for Catalonia, the alert will be generated from demographic 
data but, in this case, the information is centralized in the Database of Users (BDU) of the SAS. Each user 
in such BDU is uniquely identified by their Andalusian Health History Number (NUHSA). The tool will be 
linked to specific user data (NUHSA) to be able to apply the screening algorithm. Therefore, in this 
scenario the tool does not collect any personal data but use it to generate the alert.  
Once the health professional accesses the digital tool, he/she will have to mark in a check-list produced 
by the tool, the diseases that the patient has already been screened. This information (the check-list) will 
be registered and will be protected on a server under a secured environment ensuring data protection 
policy. In addition, access to the primary care environment (DIRAYA) requires a prior identification by 
the healthcare professional on a private and secured connection.   
Training sessions  
Health professionals from both intervention and control centres will receive training sessions, targeting 
staff of the centres including nurses, medical doctors, and other technicians. The sessions will cover 
background information on each infection, including epidemiology, diagnostic tools, treatment available, 
particular aspects in high-risk groups such as immunosuppressed patients, data on cost-effectiveness, 
and screening recommendations for migrants.   
Participants´ selection  
Therefore, when an individual comes to the PCC for any reason, the health professional will receive a 
message, in the EPR system, inserted as a pending task assignment with a recommendation on the 
diseases that should be considered for screening, based on this person's background characteristics. The 
tool is also able to identify if a person had already a diagnosis of any of the conditions included in the 
algorithm (based on ICD-10, International Classification Diagnosis codes) or if a diagnostic test had been 
performed for any condition included in the program. In such cases, the automated electronic prompt 
does not appear for that condition. A pilot test will be conducted with 3 health professionals to assure 
the correct functioning of the tool. In the control centres, we will hold just training sessions with the 
same screening recommendations as for the intervention centres but will not initiate the tool/prompts 
onto the EPR system. When the patient comes to the PCC, health professionals will decide what 
diseases/conditions should be screened for according to the information received either through the 
digital software (intervention centres) or based on their knowledge on the epidemiological background 
of the diseases (control centres), which was included in the training programme. In any case, health 
professionals will be responsible for requesting a blood test or a chest radiography and/or the derivation 
to a specialist.  

 
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Participant´s selection for the feasibility and acceptability evaluation (focus group discussions, IDIs 
and survey)  
In the pre-implementation phase, general practitioners (GP) and nurses from the selected PCCs will be 
invited by an electronic mail sent by a member of their PCC leadership team. Among those that express 
interest to participate, the research team will perform a selection based on personal characteristics 
(professional category, sex, age and time of contract with the Catalan Institute of Health for participants 
from Catalonia or the SAS for participants from Andalucía) in order to obtain discourse variability in the 
FG. In the post-implementation phase, PCCs will be selected in each geographical area where the study 
was carried out taking into account the findings of the previous study phase (real-time monitoring and 
survey to health professionals) and a consensus of the research team. Participant’s selection will be 
performed in the selected PCCs. PCC’s directors and managers of the healthcare system will be invited 
by an electronic mail sent by the study coordinator at their study area. GPs and nurses will be selected 
as explained above. 
Migrant population will be selected by one GP in each PCC. In the pre-implementation phase, the GP will 
select his/her own patients based on the following characteristics: sex, age and geographical area of 
origin. In the post-implementation phase, the GP will select his/her own patients based on sex, age, 
geographical area of origin, if the person underwent screening for any of the conditions included in the 
intervention and screening results. Each GP will call his/her patients to explain the study and invite them 
to participate. Oral consent will be obtained in that phase and registered in patient clinical history 
followed by the written consent on the day of the FG discussion or IDI. Also, the research group will 
provide the participants with a short questionnaire to collect sociodemographic data such as, age, time 
residing in Spain, sex, education level, professional status, marital status, among others detailed in the 
document ‘Information of the Patient’. All IDI and FG discussions will be conducted in the PCCs, the latter 
with 8 to approximately a maximum of 10 participants in each group. 
For the survey of the programme acceptance, a list of possible candidates (sex and gender balanced) will 
be made for both groups, health professionals and migrant patients. The same member of the PCC 
leadership team that sent the invite to the GP and nurses for the FGs of the 6 participating PCCs will send 
an anonymous questionnaire via email or WhatsApp, using the secured LimeSurvey platform, to the 
chosen health professionals and migrant patients.  Candidates will receive the invitation by email or 
message with a link to the anonymous survey and their access to it will represent their consent to 
participate.   
6. STUDY PROCEDURES, TREATMENT AND CALENDAR OF THE STUDY.  
In line with the existing national guidelines, active TB will be screened with chest radiography.  If 
radiographic findings are compatible with TB, or if TB symptoms are present, the person should be 
immediately referred to a specialist for full diagnostic workup. For HIV testing, a standard HIV ELISA test 
will be performed. For HBV, the Australian antigen (HBsAg) and the IgG Core (IgG anti-HBc) serological 
test will be performed. For HCV, an IgG-HCV test will be performed. For Chagas disease, strongyloidiasis 
and schistosomiasis, a serological test will also be performed. All of them will be processed in the 
reference laboratory facility of the PCC, being all of them based on the commercial tests available in each 
hospital of reference. Finally, for female genital mutilation, a gynaecological physical examination will be 
performed and/or referral to a gynaecologist will be carried out if required. A preventive protocol will be 
applied for girls at risk of this practice.  
In the case of a positive test result or diagnosis, the individuals will be referred to receive specialized 
care as appropriate.  
7. DATA ANALYSIS  
a. Sample size. For estimating the number of PCCs that will compose the sample in Catalonia, we have 

 
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considered that the mean migration rate in all settings is higher than 10%, then the achieved confidence 
level will exceed 95% when 32 centres or more are participating. A comparative analysis of the PCCs in 
relation to the migration density will be first performed to select the pairs of PCCs with more similar 
characteristics to assure the validity of the results.  
b. Feasibility and acceptability analysis. IDIs and FGs will be conducted in the PCCs, the latter with 8 to 
approximately an estimated maximum of 10 participants in each group. Data will be collected through 
digital audio recording. All IDIs and FGs will be manually transcribed by one interviewer and field notes 
will be made during or after the IDI/FG discussion. A thematic content analysis will be performed to 
evaluate the data from each IDI/FG. It will consist of six phases: become familiar with the data, generate 
initial codes, search for themes, review themes, define final themes and write-up. In order to validate 
the data, the coding and final categories will be triangulated by the research team. To complement this 
analysis, the analysis of the survey of the programme acceptance will be carried out.  
c.    Analysis impact of the tool. The effectiveness of the tool will be evaluated and compared in each 
pair of PCCs, the intervention compared with the control group. 
d.  The primary outcome measure will be the increased detection rate of all aggregated conditions 
included in the study in the intervention-PCCs compared with the control-PCCs. Conditions:  Chagas 
diseases, strongyloidiasis, schistosomiasis, HIV, viral hepatitis B, viral hepatitis C, active tuberculosis and 
female genital mutilation.  
Secondary outcomes will be the proportion of screening tests performed for each condition and other 
factors associated with having a higher screening rate, such as sex, age, immunosuppression status, 
being attended in an intervention centre, fulfilling the screening criteria, or coming from specific 
geographic areas. All cases will be classified using pre-defined case definitions, including the number of 
diagnoses codified through the ICD-10 code, number of positive laboratory tests, and referrals to 
specialists. To analyse the effect of the intervention on the outcomes, a difference in differences 
approach will be performed using a generalized linear model. Intervention units will be compared before 
and after implementation with respect to the monthly diagnostic rate.  Significant deviations between 
intervention and control centres before implementation will be suggestive of the main underlying 
assumption, parallel trends prior to implementation. Sandwich-robust standard errors will be clustered 
at the intervention level. For secondary outcomes, logistic regression models will be used to identify 
associations between the screening rate performed and socio-demographic, and, other health 
conditions, using area as a random intercept.  
Study variables:  
1. Sociodemographic characteristics of the Primary care health professionals: age, sex, primary 
care team (PCT)  
2. Socio demographic characteristics of migrants: age, sex, country of origin, assigned PCT, 
assigned doctor  
3. Characteristics of the PCT: intervention or control centre, number of professionals (GP and 
nurses), urban/rural centre, index of socioeconomic depravation (MEDEA), Standard Quality of 
Healthcare migration density, number of migrants with active status in the year of the 
implementation of the tool; number of migrants who did not visit any of the centres during the 
intervention; number of migrants with at least one visit during the intervention period  
4. Variables related to the use of alerts: number of migrants with screening criteria for each 
condition, number of screening tests performed for each condition, date of entry/exit into the 
system, date of visits, referral to specialists  

 
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5. Laboratory or clinical variables: X-rays, serological or microbiology tests for the conditions 
studied (HIV, HBV, HDC, Chagas disease, strongyloidiasis, and schistosomiasis). In addition, other 
laboratory parameters will be included (hemogram, including haemoglobin, platelets, 
leucocytes, neutrophils, lymphocytes, and eosinophils, IgE, liver and renal function - creatinine, 
urea, AST, ALT, GGT, bilirubin, coagulation…)  
6. Diagnostic variables: Diagnoses of each disease/condition (HIV, HBV, HCV, Chagas disease, 
strongyloidiasis, schistosomiasis and female genital mutilation) based in ICD 10 codes registered 
by health professionals in the last 10 years including the intervention period.  
7. Drug related to the diseases included in the study (e.g., ivermectine for strongyloidiasis) 
prescribed during the intervention period.  
8. Co-morbidities: Other diseases diagnoses based on ICD-10 codes registered by health 
professionals into the system in the last 10 years including the intervention period. The aim is to 
study the possible association of other diseases (diseases associated with immunosuppression, 
mental health conditions, cardiovascular and other diseases, other infectious diseases...) with 
the studied diseases/conditions. In addition, to carry out the cost-effectiveness study (an 
economic analysis that will be essential to achieve the second objective of the study) all 
parameters must be considered to adjust the model, including the comorbidities of the diseases.  
9. Immunosuppression status: Here it will include the prescription and billing of 
immunosuppressive drugs in the last 10 years including the intervention period as well as ICD-
codes on transplant, haematological diseases, cancer and related diagnoses, and autoimmune 
diseases in the last 10 years for determination of immunosuppression status.  
10. Minimum basic data set (CMBD) variables: hospitalization dates, primary diagnoses during 
hospitalizations, laboratory parameters during hospitalizations, drugs prescribed during 
hospitalization or outpatient units, cost associated or attributed to hospitalization, number of 
visits in outpatient units  
e. Cost of the screening programme and the tool. The cost of the software tool will be evaluated and 
compared with the standard care (non-tool based), considering: 1. Costs associated with screening and 
subsequent treatment of diseases and their sequelae; 2. Cost-saving resources allocated to the screening 
programme in primary care will be estimated. Besides the prevalence estimates for each condition, the 
number of cases will be compared with the previous notification rates of the notifiable diseases and with 
other prevalence studies or registries, if any, for the rest of diseases. Finally, the software tool will be 
compared with other innovative ways of improving the operationalization of the screening programmes 
implemented in other countries, such as United Kingdom or Sweden.  
f. Gender perspective. Results will also report gender inequalities concerning the access to screening 
programmes or differences in health professionals´ decision to screen specific female-related-conditions 
(e.g., female genital mutilation compared with TB or other communicable diseases).  
g. Study limitations. The retrospective data collection can lead to inaccuracy or insufficient information 
of some variables. Also, underestimation of female genital mutilation cases might result due to less 
referral of potential affected patients to specialists.  Recommendations are up to the healthcare worker 
to inform and the patient to accept it, therefore results may vary significantly by PCC. On the other hand, 
since the data of date of arrival to the country is not routinely collected at PCCs, it might not provide the 
adequate information to fulfil the active TB screening criteria proposed in the recommendations.   
h. Other aspects. A business plan model will be developed including the integration of the software in 
an application programming interface (API) to facilitate and simplify the implementation and 
maintenance of the software and the registry of the evidence of modifications of the software in the 

 
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13 
 
Property Management System Block Changes.  
8. ETHICS  
The study will be performed according to Ethical Principals of Medical Research (WMA Declaration of 
Helsinki, Fortaleza Brazil, October 2013) and following the International Ethical Guidelines for Biomedical 
Research. It will be carried out in accordance with the protocol and with the pertinent legal 
requirements: -Law 14/2007 of July 3rd on Biomedical Research, since this is a research project that does 
not involve medicines. 
The study protocol will be submitted to the ethical committee of the Hospital Clinic, IDIAP Jordi Gol in 
Barcelona and the Provincial Research of Almería. The application will consider in both cases all ethical 
considerations, including those reflected in the Charter of Fundamental Rights of the European Union 
and the European Convention on Human Rights and its Supplementary Protocols. No research will start 
until ethical approval of the new study protocol has been gained and the REA has received a scanned 
copy of all documents proving compliance with existing EU/national legislation on ethics.   
The screening programme will only provide advice or recommendations to health professionals for 
screening and early detection of infectious diseases and female genital mutilation in migrant patients 
according to the current guideline recommendations that should be considered during the routine 
practice and that will be agreed during the workshop with experts and will be summarised in a consensus 
document. Therefore, it will be the health professional, the direct beneficiary, who will finally decide 
what tests should be offered to each individual as part of the clinical practice. Accordingly, an explicit 
written consent form from the migrant individual will not be necessary. However, an informed consent 
will be required from the Director or a responsible of each PCC agreeing to the participation of their 
respective primary care team.  
Nonetheless, all individuals will be properly informed in compliance with relevant national and local 
regulations about the procedures and tests that are indicated in each case. As part of the routine health 
care, all patients being attended at those selected centres will be informed by the health professional 
about the diseases that should be screened according to their epidemiological background. Therefore, 
the person will be fully aware of the implications of different screening test results, including that some 
of the diseases are notifiable, while others are not. It will also be stressed that screening decision is 
voluntary and that not accepting the screening will in no way influence the care they will receive, or the 
assessment of the asylum rights or other resident permit criteria. Careful information, using translators 
as required, will be provided to all study subjects that cannot speak Spanish. As part of the standard 
health care, they will be informed that if there is a positive test or a diagnosis of any of the diseases, they 
will be treated or referred to a specialist as appropriate.  
On the other hand, for the execution of the FG discussions the preselection of candidates, health 
professionals and migrants, will be performed by a member of the PCC leadership team and by a GP, 
respectively. After expressing interest and accepting to participate in the study, by e-mail for the group 
of professionals and giving their oral consent by phone for the migrant group, they will be summoned 
for the date of the FG. In each of the FG discussions, signatures in the individual informed consents will 
be collected after explaining the study and the participant information sheet.   
Objection by participants/patients  
To avoid any suspicion of coercion, this study follows the code of conduct in case of objection/resistance 
of (1) health professionals to follow the recommendations that the tool is providing, or (2) of the 
individuals to be tested for any of the conditions following the current guidelines recommendations. This 
code of conduct describes both verbal objection/resistance, and non-verbal or behavioural expressions 
of objection/ resistance. Behaviour needs to be interpreted as objection if it is different from, or more 
intense than, usual behaviour in routine care.  

 
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Potential impact of the research  
This research project is not expected to have any possibly harmful impact on the individuals involved. If 
an individual is diagnosed with one of the diseases screened, he/she will be referred and treated as 
appropriate according to the routine care standard procedures of each centre.   
9. DATA MANAGEMENT AND DATA PROTECTION  
-The project involves handling personal data that are routinely collected in healthcare services.  The 
Primary Care Information System (SISAP) will supervise the technical monitoring of the tool in the 
implementation phase of the study.  
Data extraction. The data extraction process will be performed according to the principles established 
by the healthcare services, including the data protection policies in this regard. All processing of patients’ 
personal data collected within the study will be conducted according to conventional confidentiality.  
In the Catalan Institute of Health, data will be extracted from the electronic patient record system eCAP 
and pseudo-anonymized by IT staff of the System for the Development of Research in Primary Care 
(SIDIAP) Institute. The study variables will be pseudo-anonymized, with technical and functional 
separation, by a SIDIAP data manager. SIDIAP will be responsible for the data processing in Catalonia. 
Regarding SIDIAP source data, the strict SIDIAP security standards will be followed. Aggregated data will 
also be obtained via SIDIAP during the process of implementation of the tool in the Catalan Institute of 
Health with the sole objective of technical monitoring to identify alert errors and provide subsequent 
remediation.  
In Andalusia, the data will be extracted by a specialized IT committee of the SAS Institution of the area 
involved in this project. The information will be extracted retrospectively and will include: 1) the check-
list from the tool and 2) the demographic and clinical variables from the BDU. Then, the IT committee 
will link this information with the laboratory data of the reference hospital (Hospital de Poniente in 
Almeria) and will pseudo-anonymize the data.  Thereafter, the biostatistician responsible for the data 
analysis will only have access to pseudo-anonymized data without personal or sensible information. 
Thus, the privacy of individuals will be protected.  
In this regard, details on the health of migrants may have the consideration of sensitive data, as described 
in article 8 of Directive 95/46/EC (data revealing racial or ethnic origin, political opinions, religious or 
philosophical beliefs, trade-union membership, data concerning health and sex life) and therefore such 
data will be aggregated when applicable (region will be provided instead of country of origin) to avoid 
the identification of the individuals. When applicable, specific authorization by the national data 
protection authority will be obtained.   
Data processing and management. A data processing agreement will be undertaken with the Catalan 
Institute of Health/IDIAPJGoL and with Distrito Poniente de Almería, for the ownership and use of 
research data. Also, a plan for the ongoing custodial responsibilities for the research data at the 
conclusion of the project will be carried out, including recommendations for the disposal and destruction 
of the research data.  
Concerning the data-management, the treatment, communication, and transfer of personal data of all 
participants will be adjusted in compliance with EU Regulation 2016/679 of the European Parliament and 
the Council of April 2, 2016 related to the people physical protection with regards to the processing of 
personal data and the free circulation of data, being binding as of May 25, 2018. All data analysis will be 
conducted on pseudo-anonymized data and no personal data or data that could potentially identify an 
individual will be included in the final report.  
For the qualitative study, the manager of each PCT participating in the project or study coordinators will 

 
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send an email to the professionals (GPs, nurses, PCC directors and managers of the health system) and 
those who declare interest in participating will be selected to be part of the focus groups and/or IDIs. 
The migrants who will participate in the focus groups or IDI of the study will be invited in a visit or by 
telephone by their own doctor and will sign the consent form on the day of the focus groups. The 
qualitative study data will be obtained through the informed consents of the participants, in accordance 
with the provisions of articles 6.1 a) and 9.2 a) of the RGPD. In Catalonia, the audio recordings will be 
stored and secured in the local server of ISGlobal (VPN) where only participating investigators will have 
access to it. While in Andalucía the audio recordings will be stored in the UGRDrive, a high security 
storage service since it is a private cloud of the University of Granada (UGR). Only researchers of the UGR 
participating in the project will have access to these. In both settings, audio recordings will be erased 
after five years of completion of the study. No international data transfer will take place of the recordings 
made in the FG discussions and IDIs. For the survey of the programme acceptance, the secured 
LimeSurvey platform will be used as previously explained.  
Pseudo-anonymized data will also be stored in ISGlobal’s VPN and only participating investigators will 
have access to the data-base, and integrity and security of data will be maintained. In addition, a 
password will be requested to all researchers in order to access the data, registering any access. Also, a 
regular backup will be generated to avoid loss of information. An adequate documentation of data 
(metadata) -i.e., adding semantic descriptions, annotations, etc. will facilitate identification and support 
effective reuse of research data. Only encrypted data will be transferred to third parties and other 
countries, which in no case will contain information that can directly identify the participant (such as 
name, initials, address, social security number, etc.). In the event of such a transfer, it would be for the 
same purpose of the study described and would guarantee confidentiality.  
If a transfer of encrypted data takes place outside the EU, either in entities related to the hospital where 
the patient is involved, to service providers or researchers working with us, the data of the participants 
will be protected by safeguards such as contracts or other mechanisms established by the data 
protection authorities.  
In addition to the rights already provided for in the previous legislation (access, modification, opposition 
and cancellation of data, deletion in the new Regulation) participants can also limit the processing of 
data collected for the project that are incorrect, request a copy or be transferred to a third party 
(portability). In order to exercise these rights, the participants must contact the principal investigator of 
the study or the Data Protection Officer of ISGlobal via lopd@isglobal.org. Participants from the Catalan 
Institute of Health must contact the Data Protection Officer via dpd@ticsalutsocial.cat. Also, the 
participants have the right to contact the Data Protection Agency if they remain unsatisfied.  
This project does not prevent advanced data usage. In accordance with the provisions of article 35 of the 
RGPD, the project does not meet the necessary characteristics that require the performance of an impact 
assessment. 
Reutilization of data First, a standardized communications protocol to retrieve (meta) data by their 
identifier, free and universally implementable, will be generated, including a clear and accessible data 
usage license. After 10 years, all data will be eliminated and destroyed.  
Data will be anonymously uploaded in the repository, and those records that may lead to the individual 
identification of the participants will be removed or grouped with the aim of keeping their identity hidden 
at all times. Likewise, the possibility of withdrawing all the individual information of a patient will be 
guaranteed when so expressed. The data will be stored in a repository created specifically for this 
purpose in the ISGlobal data centre in the Campus Mar (Carrer del Dr. Aiguader, 88), which requires prior 
appointment with IT staff and therefore only those responsible for computer security and researchers 
linked to the project will have access to them. A series of protocols are in place to test and maintain 
network security, and to provide access management policies for network drives, databases and remote 
access. The system is protected from power interruptions, with controlled access to authorized users 

 
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16 
 
only.   
The study does not involve biological samples.  
10. FUNDING  
The ISMiHealth project received funding (87.120,00€) from the Health Research Fund Call 2021 of The 
Ministry of Science and Innovation to support this study economically. Study investigators will not 
receive any personal compensation or extra salary for participating in this study.  
11. RESULTS COMMUNICATION  
The promoter and investigators commit to publish the results of the study in journal articles, other 
scientific publications and communications to congresses. Authorship in case of publication will be 
decided according to quantitative and qualitative input to the study. The principal investigator will be 
the first or last author of the articles. 
 

 
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12. SUPPLEMENTARY FILES 
Annex 1. Screening recommendations for infectious diseases and FGM targeting the migrant population 
residing in Catalonia, Spain. 
 
1. Población diana: Se ha definido como población diana del estudio a inmigrantes que procedan de países en 
África, Latino América, Asia y Europa del Este. Se utilizó la división geográfica de la Comisión de Estadística de las 
Naciones Unidas. 
 
2. Virus de la inmunodeficiencia humana (VIH): Todas las personas deberían tener acceso a una prueba de VIH si 
lo solicitan, pero además se recomienda ofrecer el cribado a la población inmigrante procedente de áreas dónde 
la prevalencia de VIH es >1% si no se ha hecho una prueba de VIH con anterioridad. 
 
3. Otras infecciones de transmisión sexual (ITS): Se recomienda pedir pruebas para sífilis y otras ITS basado en 
factores de riesgo. Por lo tanto, no se recomienda el cribado sistemático de sífilis y otras ITS ya que no hay 
evidencia del riesgo de exposición de una persona basándose en las variables: país de origen, edad y sexo. 
 
4. Virus de la hepatitis B (VHB): Se recomienda realizar el cribado de VHB mediante la detección del antígeno 
australiano (HBsAg) y el anticuerpo contra el antígeno core (anti-HBc) a todos los inmigrantes procedentes de un 
área con prevalencia intermedia o alta de VHB (≥2%). *Además, se ofrecerá cribado de VHB a inmigrantes 
procedentes de Marruecos y Guinea Ecuatorial, aunque la prevalencia en estos países es <2%.  
 
Se ofrecerá pauta vacunal a las personas con un test serológico negativo. 
 
5. Virus de la hepatitis C (VHC): Se recomienda realizar cribado de hepatitis C mediante el anticuerpo anti-VHC a 
todos los inmigrantes procedentes de áreas con una prevalencia de VHC ≥2%. 
 
6. Tuberculosis (TB) activa: Se recomienda el cribado de TB activa utilizando radiografía de tórax a inmigrantes 
recién llegados (<5 años) procedentes de países con una incidencia >50 casos/100.000 habitantes. Si la persona 
tiene una radiografía previa, se debe valorar la situación antes de solicitar otra radiografía de tórax. 
 
7. Infección tuberculosa latente (ITL): Se decidió que no se implementará el cribado de ITL en Cataluña ya que 
nunca se ha realizado un cribado de forma sistemática para la ITL en Atención Primaria (AP), además de que la 
mayoría de los centros de AP no tienen acceso a la prueba diagnóstica IGRA, la prueba más coste-efectiva para 
detectar la ITL. Aunque no se creará una alerta específica para la ITL durante el proyecto, se recomienda que en 
un futuro se promueva la formación para poder implementar está infección en programas de cribado llevados a 
cabo en AP. 
 
8. Estrongiloidiasis: Se recomienda el cribado serológico de estrongiloidiasis a la población inmigrante 
procedente de países endémicos y si alguno de estos individuos está inmunosuprimido o tiene un potencial 
riesgo de ser inmunosuprimido en un futuro, se debería derivar a la unidad especializada del hospital de 
referencia y se debería realizar estudio de parásitos en heces. 
 
9. Esquistosomiasis: Se recomienda el cribado serológico de esquistosomiasis a la población inmigrante 
procedente de países endémicos. 
 
10. Enfermedad de Chagas: Se recomienda el cribado serológico de T. cruzi a la población inmigrante procedente 
de países endémicos.  
 
11. Mutilación genital femenina (MGF): Se recomienda valorar el riesgo de MGF y detectar los casos en niñas y 
mujeres procedentes de países endémicos. Además, es necesario formar a los profesionales de la salud en 
competencia intercultural y en cómo abordar la temática en la consulta respetando la cultura de la mujer y de su 
familia. 
 
12. Derivación: Personas diagnosticadas de alguna de las patologías incluidas en el programa de cribado deben 
ser derivadas a la unidad especializada del hospital de referencia. 
 
 
 

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
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Annex 2. Screening recommendations for infectious diseases and FGM targeting the migrant population 
residing in Andalusia, Spain. 
 
1. Población diana: Se ha definido como población diana del estudio a inmigrantes que procedan de países en 
África, Latino América, Asia y Europa del Este. Se utilizó la división geográfica de la Comisión de Estadística de las 
Naciones Unidas. 
 
2. Virus de la inmunodeficiencia humana (VIH): Se recomienda el cribado universal de VIH a todos los 
inmigrantes procedentes de un país incluido en la definición de población diana si no se ha hecho una prueba de 
VIH con anterioridad. Repetir prueba de VIH si la persona es diagnosticada con otra ITS y/o presenta otros 
factores de riesgo. 
 
3. Otras infecciones de transmisión sexual (ITS): Se recomienda el cribado universal de sífilis a todos los 
inmigrantes procedentes de un país incluido en la definición de población diana si no se ha hecho una prueba de 
sífilis con anterioridad. Repetir prueba de sífilis si la persona es diagnosticada con otra ITS y/o presenta otros 
factores de riesgo. 
 
4. Virus de la hepatitis B (VHB): Se recomienda realizar el cribado de VHB mediante la detección del antígeno 
australiano (HBsAg) y el anticuerpo contra el antígeno core (anti-HBc) a todos los inmigrantes procedentes de un 
área con prevalencia intermedia o alta de VHB (≥2%). *Además, se ofrecerá cribado de VHB a inmigrantes 
procedentes de Marruecos y Guinea Ecuatorial, aunque la prevalencia en estos países es <2%.  
Se ofrecerá pauta vacunal a las personas con un test serológico negativo. 
 
5. Virus de la hepatitis C (VHC): En el contexto del plan para la eliminación de la hepatitis C en Andalucía, se 
recomienda el cribado universal de VHC a todos los inmigrantes procedentes de un país incluido en la definición 
de población diana. 
6. Tuberculosis (TB) activa: Se recomienda el cribado de TB por Mantoux a inmigrantes asintomáticos recién 
llegados (<5 años) procedentes de países con una incidencia >50 casos/100.000 habitantes. Si el resultado es 
positivo o dudoso, realizar radiografía de tórax. 
7. Infección tuberculosa latente (ITL): De acuerdo con el protocolo de actuación que se va a implementar en el 
Distrito Sanitario de Atención Primaria Poniente, se recomienda lo siguiente, a inmigrantes <35 años, 
procedentes de países con una incidencia >50 casos/100.000 habitantes, que se puedan tratar y que no tengan 
contraindicaciones para el tratamiento de la infección tuberculosa latente:  
 
i) Tratar si procede a las personas con resultados de Mantoux >20mm. 
ii) Realizar IGRA y tratar si procede a personas vacunadas con resultados de Mantoux de 5-19mm para 
inmigrantes del Magreb y África subsahariana y de 10-19mm para el resto de los inmigrantes incluidos en la 
población diana. 
 
*Además, se incluirán en la recomendación la población inmigrante procedente de Marruecos, aunque la 
incidencia en este país es <50 casos/100.000 habitantes y se considerará realizar IGRA y tratar si procede a 
personas vacunadas con resultados de Mantoux de 5-19mm.  
 
8. Estrongiloidiasis: Se recomienda el cribado serológico de estrongiloidiasis a la población inmigrante 
procedente de países endémicos. 
 
9. Esquistosomiasis: Se recomienda el cribado serológico de esquistosomiasis a la población inmigrante 
procedente de países endémicos. 
 
10. Parásitos intestinales: Se recomienda el cribado de parásitos en heces en población inmigrante proveniente 
de países tropicales y sub tropicales, que hayan llegado en los últimos tres años al país o que hayan regresado de 
un viaje reciente a su país (visitando a amigos y familiares, VFR por sus siglas en inglés). 
 
11. Enfermedad de Chagas: Se recomienda realizar el cribado serológico de T. cruzi en mujeres en edad fértil (15-
45 años) y a personas inmunosuprimidas o en riesgo de inmunosupresión procedentes de países endémicos. 
 
12. Mutilación genital femenina (MGF): Se recomienda valorar el riesgo de MGF y detectar los casos en niñas y 
mujeres procedentes de países endémicos. Además, es necesario formar a los profesionales de la salud en 
competencia intercultural y en cómo abordar la temática en la consulta respetando la cultura de la mujer y de su 
familia.  
 

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
19 
 
13. Derivación: Personas diagnosticadas de alguna de las patologías incluidas en el programa de cribado deben 
ser derivadas a la unidad especializada del hospital de referencia. 
 
 
Annex 3. Participating PCCs in the setting of Catalonia 
Regions within the 
Autonomous Community of 
Catalonia 
Primary Care Centers 
 
 
 
 
 
Costa de Ponent 
CAP Esparreguera 
CAP Gavà-1 
CAP Molí Nou  
CAP Gornal 
CAP Sant Andreu de la Barca 
CAP Gavà-2 
CAP Camps Blancs 
CAP Sant Les Planes 
CAP Can Vidalet 
CAP El Castell 
CAP Florida Sud 
CAP Florida Nord 
 
 
 
Lleida 
CAP Lleida Rural Sud 
CAP Alfarràs - Almenar 
CAP Ponts 
CAP Almacelles 
CAP Artesa de Segre 
CAP Alcarràs 
 
 
 
 
Tarragona 
CAP El Morell 
CAP Tàrraco 
CAP Sant Pere i Sant Pau 
CAP La Canonja/Bonavista 
CAP Constantí 
CAP Jaume I 
CAP Sant Salvador/Els Pallaresos 
CAP Torreforta 
CAP El Salou 
 
 
 
Terres de l’Ebre 
CAP Deltebre 
CAP Gandesa 
CAP Baix Ebre 
CAP Amposta 
CAP Sant Carles de la Ràpita 
CAP El Temple 
CAP L’Ametlla de Mar – El Perelló 
CAP Ulldecona – La Sènia 
 
 
 

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
20 
 
 
Annex 4. Participating PCCs in the setting of Andalusia 
Region within the 
Autonomous Community of 
Andalusia 
Primary Care Centers 
 
 
 
Almería 
Centro de Salud Aguadulce Sur 
Centro de Salud Adra 
Centro de Salud El Ejido Norte 
Centro de Salud Roquetas Sur 
Centro de Salud La Mojonera 
Centro de Salud Puebla de Vícar 
Centro de Salud Roquetas Norte 
 
Annex 5. Protocol Substudy: Barriers and enablers for the detection of Female Genital Mutilation among 
migrant women at Primary Health Care 
Principal investigator of sub-study: Stella Evangelidou 
Co-investigators: Rou Sánchez, Carme Saperas, Carolina Calero, Bombo Ndir, Alessandra Queiroga, 
Emma Zucchelli, Alba Cuxart, Angeline Cruz  
Setting: Primary care centres in Catalonia and local civil society organizations/Non-Governmental 
Organizations that work with migrant populations 
1. JUSTIFICATION 
Over 200 million girls and women worldwide are estimated to be living with the effects of female genital 
mutilation (FGM), which can cause several physical, mental and sexual health complications (1). Women 
who have undergone FGM often delay or do not seek help when they experience health problems that 
may be linked to the procedure because of several reasons, such as shame, lack of access or affordability, 
normalization of certain health-related symptoms, lack of confidence in healthcare providers (2). On the 
other hand, women who do seek care for particular medical problems may not be aware about the 
complications of FGM and therefore, they may not disclose their experience of FGM to the care provider 
(2).  
Primary health care providers play an important role in supporting girls and women living with FGM, and 
improving their health and well-being (1). Providing care and treatment requires not only understanding 
women’s needs at all levels but also providing adequate information so that they can make informed 
decisions (2). It is essential that healthcare providers communicate and discuss women’s health and FGM 
status with them in a sensitive and non-judgmental manner, although this discussion can be challenging 
for both parts (2). 
Within the framework of the ISMiHealth project, which contributes to the screening and detection of 
migrant women who have suffered FGM, the research team identified the need to further investigate 
the health needs of these women and their perceptions about the way FGM is currently approached in 
Spain. Relevant recommendations on how to address this topic and a training course for healthcare 
providers will be carried out by a group of experts. 
This study intends to contribute towards the development of culturally sensitive screening methods of 
FGM that can be integrated into the ISMiHealth digital tool, so that healthcare providers can identify 

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
21 
 
those women who may have been victims of FGM and address their health needs. By improving the types 
of questions in the existing tool and the way they are structured and worded, this will allow practitioners 
to start talking about FGMs in a respectful and trustful manner with their patients.  
BIBLIOGRAPHY 
1. Person-centred communication for female genital mutilation prevention: a facilitator’s guide for 
training health-care providers. Geneva: World Health Organization; 2022.  
2. Care of women and girls living with female genital mutilation: a clinical handbook. Geneva: World 
Health Organization; 2018.  
3. Ethical considerations in research on female genital mutilation. Geneva: World Health Organization; 
2021.  
2. OBJECTIVES 
The main objective of this study is to understand the barriers and enablers that migrant women, who 
are at risk or have survived FGM, encounter when disclosing their related health needs at primary care.  
Specific objectives: 
I. To explore the belief systems around FGM among women who come from areas where the practice is 
prevalent. This includes insights on the cultural relevance and social norms associated with FGM. 
II. To examine the extent to which the health needs of this population group of women are met at 
primary health care, and the barriers encountered when seeking health care. 
III. To explore healthcare professionals´ perceptions on the detection barriers and enablers of FGM at 
primary health care.  
3. STUDY DESIGN  
The sub-study will be developed parallel to the overall project, including the following stages:  
I. A Working group with regional experts will provide advice and guidance throughout the study. It 
consists of medical doctors, community representatives, anthropologists, a psychologist and global 
health researchers. The medical doctors and the anthropologists will provide basic training on the 
thematic at the 35 primary care centres (PCCs) included in the ISMiHealth project.  
II. A literature review on existing FGM screening methods worldwide and on the health needs of women 
who have survived FGM. 
II.  A qualitative study will be conducted in 5 PCCs, local Non-Governmental Organizations (NGOs) or 
civil society organizations that work with migrant populations in Catalonia. At each site, one focus group 
(FG) discussion with women from countries where the practice is prevalent, and 5 individual in-depth 
interviews (IDIs) with women victims of FGM will take place. Each FG discussion will have an estimated 
maximum of 10 participants. In total 5 FGs and 25 IDIs will be conducted by the research team. The PCCs, 
NGOs or civil society organizations will be selected at convenience level. Participants will be selected 
using purposive strategy methods based on the community work network at each site. The sessions will 
be held in Spanish, English or French based on participants´ preference.  
Exclusion criteria will be: 

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
22 
 
- 
Individuals under 18 years of age. 
- 
Individuals who cannot speak any of the language of the focus groups.  
- 
No consent to participate.  
Before each FG and IDI, the women will need to sign the informed consent form and the form on voice 
rights transfer. Informed consent will be gained through discussion between members of the research 
team and potential participants. The discussion will be supported by written participant information 
sheets (PIS), which, along with the informed consent form, will be translated into languages relevant to 
the study population. We will use the PIS to detail the nature of the research, our objectives, and any 
risks involved with participation. The right to decline to participate, or to withdraw consent at any stage 
of the research will be explicitly stated on both the PIS and in discussion with potential participants. All 
study information (including information sheets and consent forms) will be explained orally. The 
opportunity will be given for participants to ask any questions about the scope of the research, or their 
rights as participants during the consent process. 
Data collection 
Data will be collected using topic guides which will be developed by the principal investigator and 
research team.  
Data will be recorded with audio-recorders. No sensitive information will be collected and data and 
quotes from the interview will be anonymized. 
Confidentiality 
We will de-identify data during the interview process, names will not be recorded or asked for, besides 
those provided in the signing of consent forms. 
All audio and written recordings will be de-identified and anonymised during transcription. Audio 
recordings will be deleted after five years of completion of the study. 
III. A short survey designed on LimeSurvey and RedCap platforms will be distributed to healthcare 
providers with the view to capture the factors that may inhibit and facilitate the detection of FGM during 
their clinical practice. The survey will be distributed to health professionals (primary care doctors, 
pediatricians, nurses and social workers) of PCCs  through different institutions and professional 
associations, such as, Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol 
i Gurina (IDIAPJGol), Societat Catalana de Medicina Familiar i Comunitària (CAMFiC), Associació 
d'Infermeria Familiar i Comunitària de Catalunya (AIFiCC),Societat Catalana de Pediatria, Col·legi de 
Metges de Girona (COMG) and Sociedad Española de Medicina de Familia y Comunitaria (semFYC). 
Candidates will receive the invitation to participate via an online link to the survey and their access to it 
will represent their consent to participate. 
The survey will include some profile information of the individual and their workplace, followed by 
several questions regarding their knowledge about FGM and possible consequences, barriers and 
facilitators when addressing FGM in their clinics, the importance of detecting or addressing the topic, 
prior education on FGM and training needs. 
4. DATA ANALYSIS 
For the analysis of the qualitative data collected by the FGs and IDIs, transcription and coding will be 
performed by members of the research team, led by early-career researchers who will receive required 
training and Co-Investigators’ dedicated support. Anonymised audio recordings and written 
accounts/field notes will be transcribed into Word documents, with transcription, coding and analysis 
being facilitated by NVivo software. 

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
23 
 
A thematic content analysis will be performed and the NVivo software will be used for this purpose.  The 
process for the collected data from each FG discussion and IDIs consists of the following steps: verbatim 
transcription, familiarization with transcripts, codification, categorization of coded segments, theme 
generation, triangulation, final results and write-up. For validation purposes, theme generation will be 
triangulated by at two independent researchers.  
For the analysis of the quantitative data collected from the survey with professionals´ perspectives, the 
statistical software STATA will be used to generate frequencies and inferential statistics.  
5. ETHICS  
The study will be performed according to Ethical Principals of Medical Research (WMA Declaration of 
Helsinki, Fortaleza Brazil, October 2013) and following the International Ethical Guidelines for Biomedical 
Research. It will be carried out in accordance with the protocol and with the pertinent legal 
requirements: -Law 14/2007 of July 3rd on Biomedical Research, since this is a research project that does 
not involve medicines. 
The study protocol will be submitted as a sub-study of the project “Delivering an Innovative Multi-disease 
Screening and Vaccination Tool to High-risk Migrant Populations (ISMiHealth)” already approved by the 
ethical committee of the Hospital Clinic, the IDIAP Jordi Gol in Barcelona and the Provincial Research of 
Almería. The application will consider in both cases all ethical considerations, including those reflected 
in the Charter of Fundamental Rights of the European Union and the European Convention on Human 
Rights and its Supplementary Protocols. No research will start until ethical approval of the new study 
protocol has been gained and the REA has received a scanned copy of all documents proving compliance 
with existing EU/national legislation on ethics.   
The preselection of candidates to be invited to participate in the FGs and IDIs will be performed by a 
member of the PCC research team or by a general practitioner, respectively. Candidates can also be 
contacted through members of local civil society organizations or Non-Governmental Organizations 
(NGOs). After expressing interest and accepting to participate in the study, giving their oral consent by 
phone or physically for the migrant group, they will be informed of the date of the FG or IDI. In each of 
the FG discussion or IDIs, signatures in the individual informed consents will be collected after explaining 
the study and the participant information sheet.   
Potential impact of the research  
This research project is not expected to have any possibly harmful impact on the individuals involved.  If 
an individual has been detected with FGM or any associated health problem, she will be referred and 
treated as appropriate according to the routine care standard procedures of each centre.  
6. DATA MANAGEMENT AND DATA PROTECTION  
Concerning the data-management, the treatment, communication, and transfer of personal data of all 
participants will be adjusted in compliance with EU Regulation 2016/679 of the European Parliament and 
the Council of April 2, 2016 related to the people physical protection with regards to the processing of 
personal data and the free circulation of data, being binding as of May 25, 2018. All data analysis will be 
conducted on pseudo-anonymized data and no personal data or data that could potentially identify an 
individual will be included in the final report. 
Data extraction. The data extraction process will be performed according to the principles established 
by the healthcare services, including the data protection policies in this regard. All processing of patients’ 
personal data collected within the study will be conducted according to conventional confidentiality.  

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
24 
 
Data processing and management. Migrants who will participate in the FG discussions or IDIs of the 
study will be invited in a visit or by telephone by their own doctor or they will be recruited through civil 
society organizations/NGOs working with migrant populations, and they will sign the consent form on 
the day of the FGs or IDI.  
They will be requested to answer some questions related to socio-demographic data (i.e., sex, age or 
country of birth among other, see document ‘Information of the Patient’ attached) with a statistical 
purpose of the analysis of the participants of the FG. No name or personal data will be registered. The 
questionnaire will be identified with a code and only researchers from the study will have access to these 
data. 
The qualitative study data will be obtained through the informed consents of the participants, in 
accordance with the provisions of articles 6.1 a) and 9.2 a) of the RGPD. Digital audios will be stored and 
secured in the local server of ISGlobal (VPN), where only participating investigators will have access to it. 
These will be erased after five years of completion of the study. No international data transfer will take 
place of the recordings made in the FG discussions.  
Transcriptions of the audios and questionnaires will be stored in ISGlobal’s VPN and only participating 
investigators will have access to the data-base, and integrity and security of data will be maintained. In 
addition, a password will be requested to all researchers in order to access the data, registering any 
access. Also, a regular backup will be generated to avoid loss of information. An adequate documentation 
of data (metadata) -i.e., adding semantic descriptions, annotations, etc. will facilitate identification and 
support effective reuse of research data. Only encrypted data will be transferred to third parties and 
other countries, which in no case will contain information that can directly identify the participant (such 
as name, initials, address, social security number, etc.). In the event of such a transfer, it would be for 
the same purpose of the study described and would guarantee confidentiality.  
In addition to the rights already provided for in the previous legislation (access, modification, opposition 
and cancellation of data, deletion in the new Regulation) participants can also limit the processing of 
data collected for the project that are incorrect, request a copy or be transferred to a third party 
(portability). In order to exercise these rights, the participants must contact the principal investigator of 
the study or the Data Protection Officer of ISGlobal via lopd@isglobal.org. Participants from the Catalan 
Institute of Health must contact the Data Protection Officer via dpd@ticsalutsocial.cat. Also, the 
participants have the right to contact the Data Protection Agency if they remain unsatisfied.  
This project does not prevent advanced data usage. In accordance with the provisions of article 35 of the 
RGPD, the project does not meet the necessary characteristics that require the performance of an impact 
assessment. 
Reutilization of data First, a standardized communications protocol to retrieve (meta) data by their 
identifier, free and universally implementable, will be generated, including a clear and accessible data 
usage license. After 10 years, all data will be eliminated and destroyed.  
Data will be anonymously uploaded in the repository, and those records that may lead to the individual 
identification of the participants will be removed or grouped with the aim of keeping their identity 
hidden at all times. Likewise, the possibility of withdrawing all the individual information of a patient will 
be guaranteed when so expressed. The data will be stored in a repository created specifically for this 
purpose in the ISGlobal data centre in the Campus Mar (Carrer del Dr. Aiguader, 88), which requires prior 
appointment with IT staff and therefore only those responsible for computer security and researchers 
linked to the project will have access to them. A series of protocols are in place to test and maintain 
network security, and to provide access management policies for network drives, databases and remote 
access. The system is protected from power interruptions, with controlled access to authorized users 
only.   

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
25 
 
The study does not involve biological samples.  
7. FUNDING  
The ISMiHealth project received funding (87.120,00€) from the Health Research Fund Call 2021 of The 
Ministry of Science and Innovation to support this study economically. Study investigators will not 
receive any personal compensation or extra salary for participating in this study.  
8. RESULTS COMMUNICATION  
The promoter and investigators commit to publish the results of the study in journal articles, other 
scientific publications and communications to congresses. Authorship in case of publication will be 
decided according to quantitative and qualitative input to the study. The principal investigator will be 
the first or last author of the articles. 
 
Annex 6. Protocol Substudy: The perception of migrant populations about health data collection in 
Catalonia 
Principal investigator of sub-study: Ana Requena Méndez 
Co-investigators: Daniel Kwakye, Chiara Chillè, Alba Cuxart, Angeline Cruz, Stella Evangelidou, Manu 
Krishna 
Setting: Primary care centres in Catalonia and local civil society organizations/Non-Governmental 
Organizations that work with migrant populations  
1. JUSTIFICATION  
The rapid increase in migration in recent years has brought to light the need to develop migrant and 
refugee-sensitive healthcare systems. Aspects such as poverty, ethnicity, gender, discrimination and 
persecution, risk factors linked to the migration journey and the difficulty of integration into the new 
community, need to be taken into account to provide targeted, efficient and effective healthcare to 
refugee and migrant populations and to inform policy-making and planning of the health services (1). 
This awareness has highlighted the need to strengthen health information systems and incorporate 
health variables of refugees and migrants into national datasets (1). The integration of key elements of 
data relating to refugees and migrants (for example, the country of birth, length of residence, and 
migration history) into existing data collection systems allows the disaggregation by migratory status, 
which is useful to better understand the health needs of this population and implement tailored 
interventions (1,2). 
However, data collection systems working with sensitive data involve safety and privacy concerns (1). 
Many refugees and migrants may be cautious in sharing sensitive data about their status. 
This may stem from the fear of being stigmatized or discriminated against or, for subgroups such as 
irregular migrants, the fear of being deported as a result of the misuse of information. 
Within the framework of the ISMiHealth project, in which the collection of migrants’ variables is key to 
performing an individualized risk assessment, the research team saw the need to investigate the 
perception of migrants about data collection and health indicators of the migrant population. This 
includes their thinking on the quality, quantity, and usefulness of data collection, giving the variable of 

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
26 
 
the ‘country of origin’ higher recognition - an extremely important variable for identifying specific risk 
factors of the migrant (especially concerning infectious diseases), but today rarely included in the data 
routinely collected by the host country's health system. 
BIBLIOGRAPHY 
1. World Health Organization. Collection and integration of data on refugee and migrant health in the 
WHO European Region. Copenhagen: WHO Regional Office for Europe; 2020.  
2. Bozorgmehr K, Biddle L, Rohleder S, Puthoopparambil SJ JR. What is the evidence on availability and 
integration of refugee and migrant health data in health information systems in the WHO European 
Region? (Health Evidence Network (HEN) synthesis report 66). Copenhagen: WHO Regional Office for 
Europe; 2019.  
2. HYPOTHESIS 
A more detailed and targeted migrant health data collection system is a useful tool to better understand 
the health needs of migrant populations and to strengthen disease surveillance and response capacities 
at national and cross-border levels. However, given the sensitivity of such data, refugees and migrants 
may be cautious about sharing information. There are ethical concerns regarding the collection of data 
and the potential for stigmatization and discrimination. 
Our hypothesis is that a better understanding of how the collection of personal health data is viewed 
and experienced by migrant communities, and whether or not migrants are comfortable with the 
collection of such data, can provide important information to improve the approach to migrant data 
collection and consequently the care provided.  
3. OBJECTIVES 
The aim of this study is to better understand the needs, insights and comfortableness of migrants around 
the collection of data in healthcare centres in order to be able to improve the process of data collection 
and care. 
Specific objectives: 
Aim 1: Identify the main migrant health indicators routinely registered in the electronic patient record 
systems of European countries, including those indicators for addressing the vulnerabilities of migrant 
populations. 
Aim 2: Assess the perception of migrant and refugee populations in Catalonia about the health data that 
is collected in terms of quantity, quality, and usefulness but also in terms of respect to human integrity, 
protection of human rights, or discriminatory aspects. 
4. STUDY DESIGN 
The sub-study will be developed parallel to the overall project, including the following stages:  
I. A literature review and analysis of the migrant health indicators used in the health information systems 
including those indicators for addressing the vulnerabilities of migrant populations.  
II. A survey among health professionals from different European countries to inquire about the variables 
and indicators that are collected and registered in the electronic patient record (EPR) system.  

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
27 
 
The survey will be distributed to healthcare providers at primary care level and specialists through the 
network of the Study Group on Infections in Travellers and Migrants of the European Society of Clinical 
Microbiology and Infectious Diseases (ESCMID). Candidates will receive the invitation to participate via 
an online link to the survey, designed on LimeSurvey platform, and their access to it will represent their 
consent to participate. 
The survey will include some profile information of the individual and their workplace, followed by 
several questions regarding the presence and features of the digital EPR systems, the migrant indicators 
that are routinely collected in the health information systems, the data protection policy regarding these 
indicators and the possibility of linking these data with other datasets containing migrant indicators (See 
Annex 6). 
III. A qualitative research study to assess their perception on the data collection process, whether or not 
they feel comfortable about disclosing sensitive variables (such as country of birth, time of arrival in the 
host country, legal status, reason for migration, ever resided abroad, or sociodemographic data) and 
perceived stigma around it. This will be carried out through the organization of 26 focus group (FG) 
discussions with migrant populations, of an estimated maximum of 10 people each. 4 FGs will be held in 
Spanish (2 with males and 2 with females), 4 will be held in French (2 males and 2 females), 4 in English 
(2 males and 2 females), 2 in Russian (1 males and 1 females), 2 in Malayalam (1 males and 1 females), 
and 10 in Arabic (5 males and 5 females).   
Participants’ selection and FG discussions will be carried out through different primary care centres (PCC) 
in Catalonia or local Non-Governmental Organizations (NGOs) or civil society organizations that work 
with migrant populations. The FG discussions will be carried out either at the same PCCs or at the office 
of the NGOs or civil society organizations by the research team members. Participants will be selected 
using purposive strategy methods based on the community work network at each PCC. Different 
participant profiles in terms of duration of stay in the host country will be included. The criteria for the 
composition of the groups will be age, gender, time of stay in the country and language.  
Exclusion criteria will be: 
- 
Individuals under 18 years of age. 
- 
Individuals who cannot speak any of the language of the focus groups.  
- 
No consent to participate. 
- 
There will be no exclusions based on gender nor ethnicity. 
All participants in the focus group will need to sign the informed consent form and the form on voice 
rights transfer. Informed consent will be gained through discussion between members of the research 
team and potential participants. The discussion will be supported by written participant information 
sheets (PIS), which, along with the informed consent form, will be translated into languages relevant to 
the study population. We will use the PIS to detail the nature of the research, our objectives, and any 
risks involved with participation. The right to decline to participate, or to withdraw consent at any stage 
of the research will be explicitly stated on both the PIS and in discussion with potential participants. All 
study information (including information sheets and consent forms) will be explained orally. The 
opportunity will be given for participants to ask any questions about the scope of the research, or their 
rights as participants during the consent process. 
Data collection 
Data will be collected using topic guides which will be developed by the principal investigator and 
research team.  

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
28 
 
Data will be recorded with audio-recorders. No sensitive information will be collected and data and 
quotes from the interview will be anonymized. 
Confidentiality 
We will de-identify data during the interview process, names will not be recorded or asked for, besides 
those provided in the signing of consent forms. 
All audio and written recordings will be de-identified and anonymised during transcription. Audio 
recordings will be deleted after five years of completion of the study. 
5. DATA ANALYSIS  
Transcription and coding will be performed by members of the research team, led by early-career 
researchers who will receive required training and Co-Investigators’ dedicated support. Anonymised 
audio recordings and written accounts/field notes will be transcribed into Word documents, with 
transcription, coding and analysis being facilitated by NVivo software. 
A thematic content analysis will be performed to evaluate the data from each FG discussion.  
The process for the collected data from each FG consists of the following steps: verbatim transcription, 
familiarization with transcripts, codification, categorization of coded segments, theme generation, 
triangulation, final results and write-up. In order to validate the data, the coding and final categories will 
be triangulated by the research team.  
For the analysis of the quantitative data collected from the survey with professionals´ perspectives, the 
statistical software STATA will be used to generate frequencies and inferential statistics. 
6. ETHICS  
The study will be performed according to Ethical Principals of Medical Research (WMA Declaration of 
Helsinki, Fortaleza Brazil, October 2013) and following the International Ethical Guidelines for Biomedical 
Research. It will be carried out in accordance with the protocol and with the pertinent legal 
requirements: -Law 14/2007 of July 3rd on Biomedical Research, since this is a research project that does 
not involve medicines. 
The study protocol will be submitted as a sub-study of the project “Delivering an Innovative Multi-disease 
Screening and Vaccination Tool to High-risk Migrant Populations (ISMiHealth)” already approved by the 
ethical committee of the Hospital Clinic the IDIAP Jordi Gol in Barcelona and the Provincial Research of 
Almería. The application will consider in both cases all ethical considerations, including those reflected 
in the Charter of Fundamental Rights of the European Union and the European Convention on Human 
Rights and its Supplementary Protocols. No research will start until ethical approval of the new study 
protocol has been gained and the REA has received a scanned copy of all documents proving compliance 
with existing EU/national legislation on ethics.   
The preselection of candidates to be invited to participate in the FGs will be performed by a member of 
the PCC research team, by a general practitioner or by members of NGOs or civil society organizations. 
After expressing interest and accepting to participate in the study, giving their oral consent by phone or 
physically for the migrant group, they will be informed of the date of the FG. In each of the FG discussions, 
signatures in the individual informed consents will be collected after explaining the study and the 
participant information sheet.   

 
ISMiHealth protocol version 8.0, October 10, 2024 
 
29 
 
Potential impact of the research  
This research project is not expected to have any possibly harmful impact on the individuals involved.   
7. DATA MANAGEMENT AND DATA PROTECTION  
Concerning the data-management, the treatment, communication, and transfer of personal data of all 
participants will be adjusted in compliance with EU Regulation 2016/679 of the European Parliament and 
the Council of April 2, 2016 related to the people physical protection with regards to the processing of 
personal data and the free circulation of data, being binding as of May 25, 2018. All data analysis will be 
conducted on pseudo-anonymized data and no personal data or data that could potentially identify an 
individual will be included in the final report. 
Data extraction. The data extraction process will be performed according to the principles established 
by the healthcare services, including the data protection policies in this regard. All processing of patients’ 
personal data collected within the study will be conducted according to conventional confidentiality.  
Data processing and management. Migrants who will participate in the focus groups of the study will be 
invited in a visit or by telephone by their own doctor or they will be recruited through civil society 
organizations working with migrant populations, and they will sign the consent form on the day of the 
FGs.  
They will be requested to answer some questions related to socio-demographic data (i.e., sex, age, or 
country of birth among others, see document ‘Information of the Patient’ attached) with a statistical 
purpose of the analysis of the participants of the FG. No name or personal data will be registered. The 
questionnaire will be identified with a code and only researchers from the study will have access to these 
data. 
The qualitative study data will be obtained through the informed consents of the participants, in 
accordance with the provisions of articles 6.1 a) and 9.2 a) of the RGPD. Digital audio recordings will be 
stored and secured in the local server of ISGlobal (VPN), where only participating investigators will have 
access to it. These will be erased after five years of completion of the study. No international data 
transfer will take place of the recordings made in the FG discussions.   
Transcriptions of the audios and questionnaires will be stored in ISGlobal’s VPN and only participating 
investigators will have access to the database, and integrity and security of data will be maintained. In 
addition, a password will be requested to all researchers in order to access the data, registering any 
access. Also, a regular backup will be generated to avoid loss of information. An adequate documentation 
of data (metadata) -i.e., adding semantic descriptions, annotations, etc. will facilitate identification and 
support the effective reuse of research data. Only encrypted data will be transferred to third parties and 
other countries, which in no case will contain information that can directly identify the participant (such 
as name, initials, address, social security number, etc.). In the event of such a transfer, it would be for 
the same purpose of the study described and would guarantee confidentiality.  
In addition to the rights already provided for in the previous legislation (access, modification, opposition 
and cancellation of data, deletion in the new Regulation) participants can also limit the processing of 
data collected for the project that are incorrect, request a copy or be transferred to a third party 
(portability). In order to exercise these rights, the participants must contact the principal investigator of 
the study or the Data Protection Officer of ISGlobal via lopd@isglobal.org. Participants from the Catalan 
Institute of Health must contact the Data Protection Officer via dpd@ticsalutsocial.cat. Also, the 
participants have the right to contact the Data Protection Agency if they remain unsatisfied.  

 
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This project does not prevent advanced data usage. In accordance with the provisions of article 35 of the 
RGPD, the project does not meet the necessary characteristics that require the performance of an impact 
assessment. 
Reutilization of data First, a standardized communications protocol to retrieve (meta) data by their 
identifier, free and universally implementable, will be generated, including a clear and accessible data 
usage license. After 10 years, all data will be eliminated and destroyed.  
Data will be anonymously uploaded in the repository, and those records that may lead to the individual 
identification of the participants will be removed or grouped with the aim of keeping their identity 
hidden at all times. Likewise, the possibility of withdrawing all the individual information of a patient will 
be guaranteed when so expressed. The data will be stored in a repository created specifically for this 
purpose in the ISGlobal data centre in the Campus Mar (Carrer del Dr. Aiguader, 88), which requires prior 
appointment with IT staff and therefore only those responsible for computer security and researchers 
linked to the project will have access to them. A series of protocols are in place to test and maintain 
network security, and to provide access management policies for network drives, databases, and remote 
access. The system is protected from power interruptions, with controlled access to authorized users 
only.   
The study does not involve biological samples. 
8. FUNDING  
The ISMiHealth project received funding (87.120,00€) from the Health Research Fund Call 2021 of The 
Ministry of Science and Innovation to support this study economically. Study investigators will not 
receive any personal compensation or extra salary for participating in this study.  
9. RESULTS COMMUNICATION  
The promoter and investigators commit to publish the results of the study in journal articles, other 
scientific publications and communications to congresses. Authorship in case of publication will be 
decided according to quantitative and qualitative input to the study. The principal investigator will be 
the first or last author of the articles. 
 
 

 
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Annex 6.    Online questionnaire 
 
QUESTIONNAIRE 1: MIGRANT INDICATORS IN HEALTH INFORMATION SYSTEM 
 
Background information 
My name is ________________________ and I am a medical student at the University of Barcelona. I am 
currently working on my MSc thesis project on “The perception of migrant populations about health data 
collection in Catalonia”. This project is supported by the study group for Infections in Travellers and 
Migrants (ESGITM) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) 
and coordinated by Dr. Ana Requena-Méndez, researcher at the Barcelona Institute for Global Health 
(ISGlobal) in Barcelona. 
The aim of this project is to explore what type of migrant indicators are routinely collected or registered 
in the health information systems at primary care level in European countries.  
For this purpose, we have developed a short online survey. The survey contains questions regarding the 
health information systems in your country and will not take more than 2 minutes to be completed. 
Additional information about the study can be found in the attached Study Protocol. 
We would greatly appreciate if we could have a couple of minutes of your time to answer this short 
survey. 
Many thanks for your time. 
 
Profile information: 
1. Name ____________________________________________ 
2. Profession 
Primary Care doctor 
Specialist 
Primary Care nurse 
Other ___________________________ 
3. Type of primary care centre 
    Rural                          
Urban 
    Public      
 
Private 
    Health centre         
Migrant examination centre     
 
4. Name of the Centre __________________________________ 
5. City, county ________________________________________ 
6. Country __________________________________________ 
 
Questionnaire: 
1. Does you centre/hospital have a digital electronic patient record (EPR) system? 
 
 
YES 
 
 
NO 
 
2. How is this EPR implemented in your country?   
 
 
Country level (the same EPR for the whole country) 
 
 
Regional/county/state level 
 
 
Local level 
 
3. Is this EPR system manually registering socio-demographic information for new users?  

 
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Yes,  
No, it is imported from another database containing demographic information 
 
4. Is there any migrant indicator regarding the origin routinely registered in the EPR? 
YES 
NO 
 
5. What type of indicators are included (multiple options available)? 
Migrant /non-migrants 
Country of birth 
Nationality 
 
6. Are there any other migrant indicators collected?  
 
 
YES 
NO 
 
7. What type of indicators? 
Type of migrant: Asylum seeker/refugeed/labour migrant…), 
Last country of residence 
Date of arrival to the country 
Language 
Need of interpreter 
 
 
  
8. What other migrant indicators are included? 
_________________________________________________ 
                            
9. If you have any comment or suggestion, we would be glad to hear from you: