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NCT05868005Completed

Delivering a Multi-disease Screening Tool to Migrant Populations

Delivering an Innovative Multi-disease Screening Tool to High-risk Migrant Populations

Source: ClinicalTrials.gov · Last updated 13 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
980 (actual)
First submitted
17 Apr 2023
Start date
Jan 2024
Primary completion date
Dec 2024
Lead sponsor
Barcelona Institute for Global Health
NCT number
NCT05868005

What you commit to

  • Study type: Interventional
  • Participants enrolled: 980
  • From Jan 2024 to the primary completion date, Dec 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • For the active TB recommendation, migrants residing in the host country for more than five years.
  • For FGM recommendation, being a male.

Who the study is looking for

  • 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.
  • 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.

Criteria the registry did not label

  • PCCs

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Servicio Andaluz de Salud (SAS) (administration of the participant PCCs in Andalusia)
Coordinator of this site? Confirm its status
AlmeríaSpainUnknown status
Institut Català de la Salut (ICS) (administration of the participant PCCs in Catalonia)
Coordinator of this site? Confirm its status
TortosaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.