Delivering a Multi-disease Screening Tool to Migrant Populations

NCT05868005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2025-05-13

No results posted yet for this study

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.

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

Interventions

OTHER

Clinical decision support system for screening of migrants using the ISMiHealth software tool.

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.

Sponsors & Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    collaborator OTHER
  • Distrito Sanitario Poniente de Almería

    collaborator UNKNOWN
  • Hospital de Poniente

    collaborator UNKNOWN
  • Universidad de Granada

    collaborator OTHER
  • Consorci d'Atenció Primària de Salut de l'Eixample

    collaborator OTHER
  • Barcelona Institute for Global Health

    lead OTHER

Principal Investigators

  • Ana Requena Méndez, PhD · Barcelona Institute for Global Health

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868005 on ClinicalTrials.gov