HivISMiHealthNCT05868005
Delivering a Multi-disease Screening Tool to Migrant Populations
A study testing Clinical decision support system for screening of migrants using the ISMiHealth software tool. in people with Hiv and Hepatitis B, run by Barcelona Institute for Global Health at 2 sites in Spain.
Trial summary
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 using innovative and digital solutions implemented in routine health care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Hepatitis B, Hepatitis C
- What is being tested?
- Clinical decision support system for screening of migrants using the ISMiHealth software tool.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Centres with a migration density higher than 7%.
- Primary care professionals
- Aged >18 years old working at the selected PCCs.
- Migrant populations
- Individuals assigned to a PCC.
- Patients attending the PCCs for any reason.
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- Aged >15 years old in the Catalonian site.
- Aged >14 years old in the Andalusian site.
- Coming from countries in the geographic areas of Africa, Latin-America, Asia and Eastern Europe following the categorization of the United Nations Statistical Commission.
Who cannot join
- For the active TB recommendation, migrants residing in the host country for more than five years.
- For FGM recommendation, being a male.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Servicio Andaluz de Salud (SAS) (administration of the participant PCCs in Andalusia)
Almería, Andalusia
Institut Català de la Salut (ICS) (administration of the participant PCCs in Catalonia)
Tortosa, Catalonia
About this study
Official title: Delivering an Innovative Multi-disease Screening Tool to High-risk Migrant Populations
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 using innovative and digital solutions implemented in routine health care.
This study aims to evaluate the implementation of a screening programme for migrants at primary care level in two different settings of Spain (Catalonia and Andalusia) using an innovative digital and user-friendly software tool (ISMiHealth). In Catalonia, the ISMiHealth tool has already been integrated into the Electronic Patient Record (EPR) system (eCAP) as part of a pilot study in 2018; currently, the research team aims to validate the tool in a higher number of primary care centres in this area. Therefore, a pragmatic cluster randomised controlled trial will be conducted with two parallel groups, in which selected centres using the novel software ISMiHealth will be compared to others that follow the current routine practice. On the other hand, in Andalusia a pilot cluster randomised controlled trial will be carried out, where the ISMiHealth tool will be implemented in the EPR system (DIRAYA) to evaluate the preliminary effectiveness of the tool in other settings.
The ISMiHealth software is a clinical decision support system that provides recommendations for primary healthcare professionals on screening for targeted conditions. It currently includes: 7 communicable diseases (Human immunodeficiency virus, Hepatitis B and C virus, Tuberculosis, Chagas diseases, strongyloidiasis and schistosomiasis) and one key health condition (female genital mutilation). Through routinely collected variables (country of birth, age, and sex), the software performs an individualised risk assessment and provides real-time prompts to healthcare professionals on screening for the selected health conditions. In any case, health professionals will be responsible for requesting screening tests and/or referrals to specialists.
Read the detailed description
- Objectives General objective: To develop an integrated and primary care based, communicable diseases and female genital mutilation (FGM) 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 (EPR) system of primary care in two different settings (Catalonia and Andalusia), and that aims to facilitate targeted screening to 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 birth, age, sex) and therefore specific risk factors.
- Study design This study will be developed into two sub-studies in order to accomplish the specific objectives. 2.1 Study 1 related to aim 1. Spanish consensus guidance on migrant screening recommendations.
- A comparative review and analysis of existing screening programmes at regional, national and international level will be performed.
- A report with the reviewed results will be developed and presented in the consensus workshops.
- A consensus workshop with national experts will be carried out by study site 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 Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Tuberculosis (TB), selected parasitic infections and FGM. For most of the communicable diseases, the screening criteria will be fully aligned with the current European Centre for Disease Prevention and Control (ECDC) screening guidelines and recommendations.
- To measure the level of agreement with the recommendations, a questionnaire based on a Likert 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. 2.2 Study 2 related to aim 2. Operational implementation of a screening programme using the ISMiHealth software and evaluation of its impact and equity.
- Study design and subjects. A pragmatic cluster randomised controlled trial will be conducted in 35 Primary care centers (PCCs) of Catalonia to explore and assess the effectiveness of the software tool ISMiHealth [see sample size calculation in the Statistical Analysis Plan (SAP)]. The screening programme will be implemented in a real-life context in the selected PCCs, and the receivers/users of the tool will be all health professionals (general practitioners and nurses) working at the intervention centres. On the other hand, the tool and the outcomes of the study will be evaluated in the migrant patients, the indirect beneficiaries of the tool. Additionally, a pilot clustered randomised controlled trial will be conducted in Andalusia, implementing the screening programme in six PCCs to explore preliminary effectiveness data. In the site of Catalonia approximately 840 health professionals will participate in the intervention while in Andalusia approximately 140 health professionals will participate. ISMiHealth set a series of rules that provide real-time prompts to health professionals on screening of infectious diseases and FGM in migrants. 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 conditions that should be considered for screening. For this, the software will perform an individual risk-assessment based on the patient's background characteristics (country of birth, age and sex). The software tool is also able to identify if a person had already a diagnosis of any of the conditions included in the algorithm [based on the International Classification Diagnosis codes, Ninth version (ICD-9) or Tenth version (ICD-10)] 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. Before the intervention, we will hold training sessions with the same screening recommendations for both the intervention and control centres but the latter ones will not initiate the tool/prompts onto the EPR system. In addition, a pilot test will be conducted with 3 health professionals to assure the correct functioning of the tool. At last, the ISMiHealth software will be implemented in the EPR systems of the participating PCCs.
- Implementation strategy. During 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. Quantitative indicators will also be provided by the Information Service of the Primary Care Services (SISAP) to evaluate the outcomes of the implementation.
- Intervention The implementation of the screening programme will be facilitated using a simple and user-friendly tool that helps health professionals to follow best-practice recommendations while taking into account patients' individual characteristics: country of birth , age, sex. In Catalonia, the digital tool has already been integrated into the EPR system (eCAP), a program shared by all PCCs that are part of the Catalan Institute of Health, as part of a pilot study. The three demographic variables (country of birth, age, and sex) are routinely collected by the PCCs' 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. In Andalusia, the software tool will be generated from demographic data stored in the Database of Users of the Andalusian Health Service (SAS, as its Spanish acronym). Once the health professional accesses the digital tool, he/she will have to mark in a check-list produced by the tool the conditions that the patient has already been screened for. In both study sites, the data of the patients is not registered nor collected by the tool, it is only used to produce the alert.
- Data analysis
Since the ISMiHealth tool is in different phases of implementation in each site, and the algorithms are based on different recommendations, there will be two independent data analyses: i) in Catalonia, the health impact of the tool will be evaluated in 35 PCCs; and ii) in Andalusia, the preliminary effectiveness data will be estimated in the six PCCs where the tool will be pilot tested. See SAP attached.
- Conditions
- Hiv, Hepatitis B, Hepatitis C, Tuberculosis, Chagas Disease, Schistosomiasis
- Being tested
- Clinical decision support system for screening of migrants using the ISMiHealth software tool.
- Keywords
- Screening, Migrant, Clinical decision support system, Digital software tool, Electronic patient record system, Primary care, Individual risk assessment, HIV, Hepatitis B, Hepatitis C, Tuberculosis, Chagas Disease, Schistosomiasis, Strongyloidiasis, Female genital mutilation
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis B, Hepatitis C, Tuberculosis, Chagas Disease, Schistosomiasis, Strongyloidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support system for screening of migrants using the ISMiHealth software tool.Other
Also called Former intervention: Screening migrant patients using a computer tool adapted to clinical histories in primary care (CRIBMI)., Former acronym of current study: INNoMiGs
The implementation of the screening programme will be facilitated using a simple and user-friendly software tool (ISMiHealth).
When an individual attends the PCC for any reason, the tool will generate an alert for health professionals in the EPR system, with recommendations on the conditions that should be considered for screening, based on this patient's characteristics (country of birth, age and sex). Health professionals will decide what diseases/conditions should be screened for, supported by the recommendations of the digital software (intervention centres) or based on their knowledge on the epidemiological background of the diseases (control centres). In any case, health professionals will be responsible for requesting serology tests, chest radiographies and/or referrals to specialists.
| Study group | Role | What they receive |
|---|---|---|
| Primary care centres with the ISMiHealth software tool. | Experimental | Primary care centres implementing the screening programme through the ISMiHealth software (tool-based arm). Receives: Other: Clinical decision support system for screening of migrants using the ISMiHealth software tool. |
| Primary care centres that follow current routine care. | No intervention | Primary care centres that follow the current practices in routine care (non tool-based arm). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the detection rate per month of all aggregated infections (HIV, HBV, HCV, TB, T.cruzi, S.stercoralis and Schistosoma spp. infections) between the intervention and control centres
In the Andalusian site, syphilis, latent TB and intestinal parasites will also be included. The monthly detection rate will be based on positive serologies, chest radiographies, the ICD-9 (for Andalusia) or ICD-10 (for Catalonia) of FGM and/or gynaecologist referrals, within the migrant patients who visited their assigned centre during the intervention period. Also, positive tuberculin skin test (TST) and/or Interferon Gamma Release Assay (IGRA) and stool samples will be considered for the Andalusian site. Control and intervention PCCs will be compared before and after the implementation.
Measured: Over at least 5 years until the end of the intervention (1 year).
Secondary outcomes (33)
Comparison of the detection rate per month of each individual condition, the infections and FGM cases, between the intervention and control centres
The monthly detection rate will be based on positive serologies, chest radiographies, ICD-9/ICD-10 of FGM and/or gynaecologist referrals, TST/IGRA and stool samples (for Andalusia), within the migrant patients who visited their assigned centre during the intervention period. Control and intervention PCCs will be compared before and after the implementation.
Measured: Over at least 5 years until the end of the intervention (1 year).
Comparison of the number of early HIV diagnoses
The number of early diagnoses of HIV will be assessed using the CD4 cell count of migrant patients diagnosed with an HIV infection. The early diagnoses will be compared between the control and intervention PCCs before and after the implementation. If possible, we will estimate the monthly detection rate of early diagnoses and also compare it between the intervention and control PCCs.
Measured: Over at least 5 years until the end of the intervention (1 year).
Comparison of the number of early HBV and HCV diagnoses
The number of early diagnoses of HBV and HCV will be assessed using the levels of transaminases, platelets, bilirubin, and clotting parameters from blood analyses of migrant patients diagnosed with HBV or HCV. The early diagnoses will be compared between the control and intervention PCCs before and after the implementation. If possible, we will estimate the monthly detection rate of early diagnoses and also compare it between the intervention and control PCCs.
Measured: Over at least 5 years until the end of the intervention (1 year).
Comparison of the number of screening tests performed for all aggregated infections
The number of the screening tests performed for all aggregated infections (serological tests, chest radiographies, TST or IGRA tests and stool samples in the case of the Andalusian site) will be compared between the intervention and control PCCs before and after the implementation.
Measured: Over at least 5 years until the end of the intervention (1 year).
Comparison of the the number of screening tests performed for each individual condition
The number of the screening tests performed for each individual condition will be compared between the intervention and control PCCs before and after the implementation.
Measured: Over at least 5 years until the end of the intervention (1 year).
Associations between the screening performance of all aggregated infections (yes/no) and patients' age (in years) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and patients' age as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the time that patients have been registered in the Spanish National Health System (in years) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and time registered in the Spanish Health System as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and patients' sex (female/male) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and patients' sex as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and patients' area of birth (Africa/Latin America/Asia/Eastern Europe) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and patients' area of birth as the predictor variable. The areas of birth will be based in the geographical division of the United Nations Statistical Division.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the region where the PCC is located (Terres de l'Ebre/Lleida/Tarragona/Costa de Ponent) will be analysed using the data collected in the SISAP database
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and the region of the PCC as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the type of region where the PCC is located in Catalonia, Spain (urban/rural) will be analysed using the data collected in the SISAP database
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and the type of region of the PCC as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and if the patient fulfilled the criteria of the screening recommendation (yes/no) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and fulfilled the criteria of the screening recommendation (yes- if the patient had the criteria of being tested for at least one infection, criteria generated by the algorithm of the ISMiHealth software using the variables country of birth, age and sex/no- if the patient did not meet the criteria) as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the arm of the study (Intervention/Control) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and the arm of the study as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and patients' immunosuppression status (yes/no) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and patients' immunosuppression status (yes- if the patient has an ICD-code diagnosis of an immunosuppressive disorder and/or have a prescription of an immunosuppressive drug/no- if the patient is not immunosuppressed) as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the presence of another condition (yes/no) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of the aggregated infections (yes-if the patient has been tested for at least one of the seven infections during the study period/no-if the patient was not tested) as the outcome variable and the presence of another condition (yes- if the patient has an ICD-code of another condition [co-morbidity]/no- if the patient does not present another condition) as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' age (in years) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and patients' age as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the time that patients have been registered in the Spanish Health System (in years) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and time registered in the Spanish Health System as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' sex (female/male) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes- yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and patients' sex as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' area of birth (Africa/Latin America/Asia/Eastern Europe) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and patients' area of birth as the predictor variable. The areas of birth will be based in the geographical division of the United Nations Statistical Division.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the region where the PCC is located (Terres de l'Ebre/Lleida/Tarragona/Costa de Ponent) will be analysed using data collected in the SISAP database
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and the region of the PCC as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the type of region where the PCC is located in Catalonia, Spain (urban/rural) will be analysed using the data collected in the SISAP database
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and the type of region of the PCC as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance each individual condition (yes/no), including FGM, and if the patient fulfilled the criteria of the screening recommendation (yes/no) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and fulfilled the criteria of the screening recommendation (yes- if the patient had the criteria of being tested for at least one infection, criteria generated by the algorithm of the ISMiHealth software using the variables country of birth, age and sex/no- if the patient did not meet the criteria) as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the arm of the study (Intervention/Control) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and the arm of the study as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' immunosuppression status (yes/no) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and patients' immunosuppression status (yes- if the patient has an ICD-code diagnosis of an immunosuppressive disorder and/or have a prescription of an immunosuppressive drug/no- if the patient is not immunosuppressed) as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the presence of another condition (yes/no) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for one of the seven infections and/or screened for female genital mutilation/no-if the patient was not tested) as the outcome variable and the presence of another condition (yes- if the patient has an ICD-code of another condition [co-morbidity]/no- if the patient does not present another condition) as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of HIV (yes/no) and the CD4 cell count (cell/µL) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for HIV during the study period/no-if the patient was not tested) as the outcome variable and the CD4 cell count as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of HIV (yes/no) and the viral load (copies/mL) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for HIV /no-if the patient was not tested) as the outcome variable and the viral load as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of platelets (U/µL) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for HBV and/or HCV /no-if the patient was not tested) as the outcome variable and the levels of platelets as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of transaminases (U/L) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for HBV and/or HCV /no-if the patient was not tested) as the outcome variable and the levels of transaminases as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of bilirubin (mg/dL) will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for HBV and/or HCV /no-if the patient was not tested) as the outcome variable and the levels of bilirubin as the predictor variable.
Measured: Through study completion, 1 year.
Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of clotting parameters [such as prothrombin (seconds), fibrinogen (mg/dL), among others] will be analysed using the data collected from the EPR system
Bivariate and multivariate analysis (Fisher's exact tests, Chi-square tests and/or logistic regressions) will be performed using the screening performance of each individual condition (yes-if the patient has been tested for HBV and/or HCV /no-if the patient was not tested) as the outcome variable and the levels of clotting parameters as the predictor variable.
Measured: Through study completion, 1 year.
Number of diagnosed individuals with follow-up visits in the hospital of reference
The number of migrant patients under follow-up in the hospital after a diagnosis of an infection or FGM will be estimated using the Minimum basic dataset (MBDS).
Measured: Through study completion, 1 year.
Number of diagnosed individuals under treatment
The number of migrant patients under treatment after a diagnosis will be estimated using data from the EPR systems and the MBDS.
Measured: Through study completion, 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic cluster controlled randomised trial will be conducted in 35 PCCs in Catalonia. The randomization will be performed through a statistical software for each pair of selected health centres, stratified by study area and by density of migrant population in the area (low, medium and high). For each pair of PCCs, one PCC will be randomly selected to implement the screening program through the ISMiHealth software, and it will be compared with the other PCC, which will follow the current routine care practices. In both cases, health professionals will receive a training session on migrant health; the contents will include, for each condition, epidemiological aspects, diagnosis, treatment, and the screening recommendation. Around 980 health professionals will participate as software users but the exact number may vary due to replacements, sick leaves, rotations, etc. In Andalusia, a pilot cluster randomized trial will be carried out to evaluate preliminary effectiveness data.
- Masking
- None (open label)
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Distrito Sanitario Poniente de Almería, Hospital de Poniente, Universidad de Granada, Consorci d'Atenció Primària de Salut de l'Eixample
- Responsible party
- Sponsor
- Investigators
- Ana Requena Méndez, PhD, Principal investigator, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868005
- Sponsor's protocol ID
- PI21/00651
- Acronym
- ISMiHealth
- Status last verified
- Sep 2024
- First submitted
- 17 Apr 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The project involves handling personal data that are routinely collected in healthcare services. Data will be obtained retrospectively and study variables will be pseudo-anonymized by the IT staff of each healthcare system. Pseudo-anonymized data will be stored and secured in the local server of ISGlobal (VPN) and only participating investigators will have access to it. An adequate documentation of (meta) data will facilitate identification and support effective reuse of research data. A standardized communications protocol to retrieve (meta) data will be generated. Anonymous data will be stored in a repository in ISGlobal's data centre (Carrer Dr. Aiguader, 88) for 10 years. Only encrypted data will be transferred to third parties and other countries, solely for the same purpose of the study described and would guarantee confidentiality. Data will be findable for the research community through the trial registration and scientific publications.
Publications
Sequeira-Aymar E, diLollo X, Osorio-Lopez Y, Goncalves AQ, Subira C, Requena-Mendez A. [Recommendations for the screening for infectious diseases, mental health, and female genital mutilation in immigrant patients seen in Primary Care]. Aten Primaria. 2020 Mar;52(3):193-205. doi: 10.1016/j.aprim.2019.02.005. Epub 2019 Apr 25. Spanish.
PubMed 31029458Sequeira-Aymar E, Cruz A, Serra-Burriel M, di Lollo X, Goncalves AQ, Camps-Vila L, Monclus-Gonzalez MM, Revuelta-Munoz EM, Busquet-Sole N, Sarriegui-Dominguez S, Casellas A, Llorca MRD, Aguilar-Martin C, Jacques-Avino C, Hargreaves S, Requena-Mendez A; CRIBMI (IS-MiHealth) Working Group. 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. 2022 Nov 4;29(7):taab100. doi: 10.1093/jtm/taab100.
PubMed 34230959Cruz A, Cuxart-Graell A, Goncalves AQ, Vazquez-Villegas J, Vallejo-Godoy S, Salas-Coronas J, Piqueras N, Martinez-Torres S, Artigues-Barbera E, Rando-Matos Y, Margalejo AA, Vizcaino J, Requena P, Martinez-Perez A, Ferrer E, Mendez-Boo L, Coma E, Luzon-Garcia MP, Sequeira-Aymar E, Casellas A, Vazquez M, Jacques-Avino C, Medina-Perucha L, Sicuri E, Evangelidou S, Aguilar Martin C, Requena-Mendez A. Delivering an innovative multi-infection and female genital mutilation screening to high-risk migrant populations (ISMiHealth): study protocol of a cluster randomised controlled trial with embedded process evaluation. BMJ Open. 2024 Nov 4;14(11):e078337. doi: 10.1136/bmjopen-2023-078337.
PubMed 39496367
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering an Innovative Multi-disease Screening Tool to High-risk Migrant Populations
- ClinicalTrials.gov ID
- NCT05868005
- Acronym / sponsor ID
- ISMiHealth / PI21/00651
- Conditions
- Hiv, Hepatitis B, Hepatitis C, Tuberculosis, Chagas Disease, Schistosomiasis
- Keywords
- Screening, Migrant, Clinical decision support system, Digital software tool, Electronic patient record system, Primary care, Individual risk assessment, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Distrito Sanitario Poniente de Almería, Hospital de Poniente, Universidad de Granada, Consorci d'Atenció Primària de Salut de l'Eixample
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 using innovative and digital solutions implemented in routine health care.
This study aims to evaluate the implementation of a screening programme for migrants at primary care level in two different settings of Spain (Catalonia and Andalusia) using an innovative digital and user-friendly software tool (ISMiHealth). In Catalonia, the ISMiHealth tool has already been integrated into the Electronic Patient Record (EPR) system (eCAP) as part of a pilot study in 2018; currently, the research team aims to validate the tool in a higher number of primary care centres in this area. Therefore, a pragmatic cluster randomised controlled trial will be conducted with two parallel groups, in which selected centres using the novel software ISMiHealth will be compared to others that follow the current routine practice. On the other hand, in Andalusia a pilot cluster randomised controlled trial will be carried out, where the ISMiHealth tool will be implemented in the EPR system (DIRAYA) to evaluate the preliminary effectiveness of the tool in other settings.
The ISMiHealth software is a clinical decision support system that provides recommendations for primary healthcare professionals on screening for targeted conditions. It currently includes: 7 communicable diseases (Human immunodeficiency virus, Hepatitis B and C virus, Tuberculosis, Chagas diseases, strongyloidiasis and schistosomiasis) and one key health condition (female genital mutilation). Through routinely collected variables (country of birth, age, and sex), the software performs an individualised risk assessment and provides real-time prompts to healthcare professionals on screening for the selected health conditions. In any case, health professionals will be responsible for requesting screening tests and/or referrals to specialists.
Detailed description
- Objectives General objective: To develop an integrated and primary care based, communicable diseases and female genital mutilation (FGM) 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 (EPR) system of primary care in two different settings (Catalonia and Andalusia), and that aims to facilitate targeted screening to 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 birth, age, sex) and therefore specific risk factors.
- Study design This study will be developed into two sub-studies in order to accomplish the specific objectives. 2.1 Study 1 related to aim 1. Spanish consensus guidance on migrant screening recommendations.
- A comparative review and analysis of existing screening programmes at regional, national and international level will be performed.
- A report with the reviewed results will be developed and presented in the consensus workshops.
- A consensus workshop with national experts will be carried out by study site 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 Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Tuberculosis (TB), selected parasitic infections and FGM. For most of the communicable diseases, the screening criteria will be fully aligned with the current European Centre for Disease Prevention and Control (ECDC) screening guidelines and recommendations.
- To measure the level of agreement with the recommendations, a questionnaire based on a Likert 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. 2.2 Study 2 related to aim 2. Operational implementation of a screening programme using the ISMiHealth software and evaluation of its impact and equity.
- Study design and subjects. A pragmatic cluster randomised controlled trial will be conducted in 35 Primary care centers (PCCs) of Catalonia to explore and assess the effectiveness of the software tool ISMiHealth [see sample size calculation in the Statistical Analysis Plan (SAP)]. The screening programme will be implemented in a real-life context in the selected PCCs, and the receivers/users of the tool will be all health professionals (general practitioners and nurses) working at the intervention centres. On the other hand, the tool and the outcomes of the study will be evaluated in the migrant patients, the indirect beneficiaries of the tool. Additionally, a pilot clustered randomised controlled trial will be conducted in Andalusia, implementing the screening programme in six PCCs to explore preliminary effectiveness data. In the site of Catalonia approximately 840 health professionals will participate in the intervention while in Andalusia approximately 140 health professionals will participate. ISMiHealth set a series of rules that provide real-time prompts to health professionals on screening of infectious diseases and FGM in migrants. 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 conditions that should be considered for screening. For this, the software will perform an individual risk-assessment based on the patient's background characteristics (country of birth, age and sex). The software tool is also able to identify if a person had already a diagnosis of any of the conditions included in the algorithm [based on the International Classification Diagnosis codes, Ninth version (ICD-9) or Tenth version (ICD-10)] 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. Before the intervention, we will hold training sessions with the same screening recommendations for both the intervention and control centres but the latter ones will not initiate the tool/prompts onto the EPR system. In addition, a pilot test will be conducted with 3 health professionals to assure the correct functioning of the tool. At last, the ISMiHealth software will be implemented in the EPR systems of the participating PCCs.
- Implementation strategy. During 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. Quantitative indicators will also be provided by the Information Service of the Primary Care Services (SISAP) to evaluate the outcomes of the implementation.
- Intervention The implementation of the screening programme will be facilitated using a simple and user-friendly tool that helps health professionals to follow best-practice recommendations while taking into account patients' individual characteristics: country of birth , age, sex. In Catalonia, the digital tool has already been integrated into the EPR system (eCAP), a program shared by all PCCs that are part of the Catalan Institute of Health, as part of a pilot study. The three demographic variables (country of birth, age, and sex) are routinely collected by the PCCs' 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. In Andalusia, the software tool will be generated from demographic data stored in the Database of Users of the Andalusian Health Service (SAS, as its Spanish acronym). Once the health professional accesses the digital tool, he/she will have to mark in a check-list produced by the tool the conditions that the patient has already been screened for. In both study sites, the data of the patients is not registered nor collected by the tool, it is only used to produce the alert.
- Data analysis
Since the ISMiHealth tool is in different phases of implementation in each site, and the algorithms are based on different recommendations, there will be two independent data analyses: i) in Catalonia, the health impact of the tool will be evaluated in 35 PCCs; and ii) in Andalusia, the preliminary effectiveness data will be estimated in the six PCCs where the tool will be pilot tested. See SAP attached.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic cluster controlled randomised trial will be conducted in 35 PCCs in Catalonia. The randomization will be performed through a statistical software for each pair of selected health centres, stratified by study area and by density of migrant population in the area (low, medium and high). For each pair of PCCs, one PCC will be randomly selected to implement the screening program through the ISMiHealth software, and it will be compared with the other PCC, which will follow the current routine care practices. In both cases, health professionals will receive a training session on migrant health; the contents will include, for each condition, epidemiological aspects, diagnosis, treatment, and the screening recommendation. Around 980 health professionals will participate as software users but the exact number may vary due to replacements, sick leaves, rotations, etc. In Andalusia, a pilot cluster randomized trial will be carried out to evaluate preliminary effectiveness data.
| Arm | Type | Receives |
|---|---|---|
| Primary care centres with the ISMiHealth software tool. | Experimental | Other: Clinical decision support system for screening of migrants using the ISMiHealth software tool.Primary care centres implementing the screening programme through the ISMiHealth software (tool-based arm). |
| Primary care centres that follow current routine care. | No intervention | –Primary care centres that follow the current practices in routine care (non tool-based arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Centres with a migration density higher than 7%.
- Primary care professionals
- Aged >18 years old working at the selected PCCs.
- Migrant populations
- Individuals assigned to a PCC.
Key exclusion criteria (2 listed)
- For the active TB recommendation, migrants residing in the host country for more than five years.
- For FGM recommendation, being a male.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision support system for screening of migrants using the ISMiHealth software tool.Also: Former intervention: Screening migrant patients using a computer tool adapted to clinical histories in primary care (CRIBMI)., Former acronym of current study: INNoMiGsThe implementation of the screening programme will be facilitated using a simple and user-friendly software tool (ISMiHealth). When an individual attends the PCC for any reason, the tool will generate an alert for health professionals in the EPR system, with recommendations on the conditions that should be considered for screening, based on this patient's characteristics (country of birth, age and sex). Health professionals will decide what diseases/conditions should be screened for, supported by the recommendations of the digital software (intervention centres) or based on their knowledge on the epidemiological background of the diseases (control centres). In any case, health professionals will be responsible for requesting serology tests, chest radiographies and/or referrals to specialists. | Other | Primary care centres with the ISMiHealth software tool. |
Primary outcome
Comparison of the detection rate per month of all aggregated infections (HIV, HBV, HCV, TB, T.cruzi, S.stercoralis and Schistosoma spp. infections) between the intervention and control centres
Time frame: Over at least 5 years until the end of the intervention (1 year).
In the Andalusian site, syphilis, latent TB and intestinal parasites will also be included. The monthly detection rate will be based on positive serologies, chest radiographies, the ICD-9 (for Andalusia) or ICD-10 (for Catalonia) of FGM and/or gynaecologist referrals, within the migrant patients who visited their assigned centre during the intervention period. Also, positive tuberculin skin test (TST) and/or Interferon Gamma Release Assay (IGRA) and stool samples will be considered for the Andalusian site. Control and intervention PCCs will be compared before and after the implementation.
33 secondary outcomes
Comparison of the detection rate per month of each individual condition, the infections and FGM cases, between the intervention and control centres
Time frame: Over at least 5 years until the end of the intervention (1 year).
Comparison of the number of early HIV diagnoses
Time frame: Over at least 5 years until the end of the intervention (1 year).
Comparison of the number of early HBV and HCV diagnoses
Time frame: Over at least 5 years until the end of the intervention (1 year).
Comparison of the number of screening tests performed for all aggregated infections
Time frame: Over at least 5 years until the end of the intervention (1 year).
Comparison of the the number of screening tests performed for each individual condition
Time frame: Over at least 5 years until the end of the intervention (1 year).
Associations between the screening performance of all aggregated infections (yes/no) and patients' age (in years) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the time that patients have been registered in the Spanish National Health System (in years) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and patients' sex (female/male) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and patients' area of birth (Africa/Latin America/Asia/Eastern Europe) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the region where the PCC is located (Terres de l'Ebre/Lleida/Tarragona/Costa de Ponent) will be analysed using the data collected in the SISAP database
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the type of region where the PCC is located in Catalonia, Spain (urban/rural) will be analysed using the data collected in the SISAP database
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and if the patient fulfilled the criteria of the screening recommendation (yes/no) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the arm of the study (Intervention/Control) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and patients' immunosuppression status (yes/no) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of all aggregated infections (yes/no) and the presence of another condition (yes/no) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' age (in years) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the time that patients have been registered in the Spanish Health System (in years) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' sex (female/male) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' area of birth (Africa/Latin America/Asia/Eastern Europe) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the region where the PCC is located (Terres de l'Ebre/Lleida/Tarragona/Costa de Ponent) will be analysed using data collected in the SISAP database
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the type of region where the PCC is located in Catalonia, Spain (urban/rural) will be analysed using the data collected in the SISAP database
Time frame: Through study completion, 1 year.
Associations between the screening performance each individual condition (yes/no), including FGM, and if the patient fulfilled the criteria of the screening recommendation (yes/no) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the arm of the study (Intervention/Control) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' immunosuppression status (yes/no) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of each individual condition (yes/no), including FGM, and the presence of another condition (yes/no) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of HIV (yes/no) and the CD4 cell count (cell/µL) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of HIV (yes/no) and the viral load (copies/mL) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of platelets (U/µL) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of transaminases (U/L) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of bilirubin (mg/dL) will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of clotting parameters [such as prothrombin (seconds), fibrinogen (mg/dL), among others] will be analysed using the data collected from the EPR system
Time frame: Through study completion, 1 year.
Number of diagnosed individuals with follow-up visits in the hospital of reference
Time frame: Through study completion, 1 year.
Number of diagnosed individuals under treatment
Time frame: Through study completion, 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 31029458Sequeira-Aymar E, diLollo X, Osorio-Lopez Y, Goncalves AQ, Subira C, Requena-Mendez A. [Recommendations for the screening for infectious diseases, mental health, and female genital mutilation in immigrant patients seen in Primary Care]. Aten Primaria. 2020 Mar;52(3):193-205. doi: 10.1016/j.aprim.2019.02.005. Epub 2019 Apr 25. Spanish.
- Background: PubMed 34230959Sequeira-Aymar E, Cruz A, Serra-Burriel M, di Lollo X, Goncalves AQ, Camps-Vila L, Monclus-Gonzalez MM, Revuelta-Munoz EM, Busquet-Sole N, Sarriegui-Dominguez S, Casellas A, Llorca MRD, Aguilar-Martin C, Jacques-Avino C, Hargreaves S, Requena-Mendez A; CRIBMI (IS-MiHealth) Working Group. 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. 2022 Nov 4;29(7):taab100. doi: 10.1093/jtm/taab100.
- Derived from this study: PubMed 39496367Cruz A, Cuxart-Graell A, Goncalves AQ, Vazquez-Villegas J, Vallejo-Godoy S, Salas-Coronas J, Piqueras N, Martinez-Torres S, Artigues-Barbera E, Rando-Matos Y, Margalejo AA, Vizcaino J, Requena P, Martinez-Perez A, Ferrer E, Mendez-Boo L, Coma E, Luzon-Garcia MP, Sequeira-Aymar E, Casellas A, Vazquez M, Jacques-Avino C, Medina-Perucha L, Sicuri E, Evangelidou S, Aguilar Martin C, Requena-Mendez A. Delivering an innovative multi-infection and female genital mutilation screening to high-risk migrant populations (ISMiHealth): study protocol of a cluster randomised controlled trial with embedded process evaluation. BMJ Open. 2024 Nov 4;14(11):e078337. doi: 10.1136/bmjopen-2023-078337.
- Individual participant dataSharing planned: Yes. The project involves handling personal data that are routinely collected in healthcare services. Data will be obtained retrospectively and study variables will be pseudo-anonymized by the IT staff of each healthcare system. Pseudo-anonymized data will be stored and secured in the local server of ISGlobal (VPN) and only participating investigators will have access to it. An adequate documentation of (meta) data will facilitate identification and support effective reuse of research data. A standardized communications protocol to retrieve (meta) data will be generated. Anonymous data will be stored in a repository in ISGlobal's data centre (Carrer Dr. Aiguader, 88) for 10 years. Only encrypted data will be transferred to third parties and other countries, solely for the same purpose of the study described and would guarantee confidentiality. Data will be findable for the research community through the trial registration and scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Requena Méndez, PhD principal investigator
Barcelona Institute for Global Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support system for screening of migrants using the ISMiHealth software tool. in people with Hiv and Hepatitis B, run by Barcelona Institute for Global Health at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the detection rate per month of all aggregated infections (HIV, HBV, HCV, TB, T.cruzi, S.stercoralis and Schistosoma spp. infections) between the intervention and control centres (time frame: Over at least 5 years until the end of the intervention (1 year).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868005, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.