Delivering a Multi-disease Screening Tool to Migrant Populations
ISMiHealth
Delivering an Innovative Multi-disease Screening Tool to High-risk Migrant Populations
1 other identifier
interventional
980
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Jan 2024
Shorter than P25 for not_applicable hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 13, 2025
September 1, 2024
1 year
April 17, 2023
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Over at least 5 years until the end of the intervention (1 year).
Comparison of the number of early HIV diagnoses
Over at least 5 years until the end of the intervention (1 year).
Comparison of the number of early HBV and HCV diagnoses
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
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
Over at least 5 years until the end of the intervention (1 year).
- +28 more secondary outcomes
Other Outcomes (1)
Prevalence of each individual condition in the migrant population
Through study completion, 1 year.
Study Arms (2)
Primary care centres with the ISMiHealth software tool.
EXPERIMENTALPrimary care centres implementing the screening programme through the ISMiHealth software (tool-based arm).
Primary care centres that follow current routine care.
NO INTERVENTIONPrimary care centres that follow the current practices in routine care (non tool-based arm).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Centres with a migration density higher than 7%.
- II) Primary care professionals
- Aged \>18 years old working at the selected PCCs.
- III) Migrant populations
- Individuals assigned to a PCC.
- Patients attending the PCCs for any reason.
- 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.
You may not qualify if:
- For the active TB recommendation, migrants residing in the host country for more than five years.
- For FGM recommendation, being a male.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barcelona Institute for Global Healthlead
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurinacollaborator
- Distrito Sanitario Poniente de Almeríacollaborator
- Hospital de Ponientecollaborator
- Universidad de Granadacollaborator
- Consorci d'Atenció Primària de Salut de l'Eixamplecollaborator
Study Sites (2)
Servicio Andaluz de Salud (SAS) (administration of the participant PCCs in Andalusia)
Almería, Andalusia, Spain
Institut Català de la Salut (ICS) (administration of the participant PCCs in Catalonia)
Tortosa, Catalonia, Spain
Related Publications (3)
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.
PMID: 31029458BACKGROUNDSequeira-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.
PMID: 34230959BACKGROUNDCruz 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.
PMID: 39496367DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Requena Méndez, PhD
Barcelona Institute for Global Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2023
First Posted
May 22, 2023
Study Start
January 1, 2024
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
May 13, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data and metadata will be deposited into ISGlobal's repository at the time of publication or by the end of the project period, whichever comes first. After 10 years, all data will be eliminated and destroyed.
- Access Criteria
- Pseudo-anonymized data in ISGlobal's VPN will only be accessed by investigators. In addition, a password will be requested to all researchers in order to access the data, registering any access. Anonymous data will be available from the corresponding author upon reasonable request.
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.