MediationECEMSoNCT06180746
Study of the Conditions of the Effects of Health Mediation on Underserved Population
An observational study of Mediation, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The investigators are conducting a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The ECEMSo study aims to identify the impact of health mediation on fostering healthcare utilization, in particular organized cancer screening uptake, by underserved… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediation
- What is being tested?
- Knowledge mobilization to facilitate the structuring of health mediation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,041 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Underserved Population
Who may be able to join
- Living on the streets, in a shanty house, squat or caravan
- Living in an area covered by one of care structures participating in the ECEMSo study
- Being over 18 years old
- Being able to understand the detailed information provided about the ECEMso study
- Being a health mediator, a health worker or a social worker belonging to one of the study's participation care structures
- Providing support to people living in informal housing
Who cannot join
- Suffering from cognitive and/or psychiatric disorders
- Being under guardianship or curatorship
- Health mediators, heal workers, socials workers
- Stakeholder:
- Inclusion criteria: Being an actor concerned or involved with the issues and needs of people living in informal housing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Conditions of the Effects of Health Mediation on Underserved Populations' Healthcare Utilization
The investigators are conducting a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The ECEMSo study aims to identify the impact of health mediation on fostering healthcare utilization, in particular organized cancer screening uptake, by underserved populations living in informal housing in France.
Read the detailed description
Health mediation may foster underserved populations' healthcare utilization. No study to date has demonstrated its effectiveness in an experimental context. The ECEMSo case study aims to identify the impact of health mediation on fostering healthcare utilization - in particular organized cancer screening uptake - by underserved populations living in informal housing in France.
Grounded in a theory-based framework, the ECEMSo case study is a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The study population comprises various participant profiles including health mediators, health workers, social workers, people living in informal housing whom these professionals support, and other stakeholders concerned with underserved populations' health issues. Participants will be recruited in several French regions and divided into three mixed participant profile groups. In group 1, health mediation and the ECEMSo intervention will be implemented. This intervention comprises knowledge mobilization to facilitate the structuring of health mediation throughout France, and the development of an action plan to facilitate cancer screening uptake by people living in informal housing. In group 2, only health mediation will be implemented (i.e., no ECEMSo intervention). In group 3, neither health mediation nor the ECEMSo intervention will be implemented, but health and social workers will implement other health system navigation interventions.
Quantitative and qualitative data will be collected by interviewers through face-to-face questionnaires, interviews, observations, focus groups, and tracking tables of health mediation activities over six months. Data collection will be based on the health mediation conceptual framework.
- Conditions
- Mediation
- Being tested
- Knowledge mobilization to facilitate the structuring of health mediation
- Keywords
- Healthcare utilization, Health mediation, Cancer screening, Complex intervention, realist evaluation, study protocol, underserved populations
- Medical subject headings
- Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge mobilization to facilitate the structuring of health mediationBehavioural
The ECEMSo intervention involves knowledge mobilization to facilitate the structuring of health mediation throughout French territory, and the development of a co-designed effective action plan to facilitate cancer screening uptake by people living in informal housing.
The action plan will, consider territorial specificities at the regional level. The ECEMSo project team will organize a seminar and three workshops. The aim of the seminar and workshops is to mobilize knowledge to facilitate i) the structuring of health mediation in the regions, and ii) the development of an action plan with health mediators and other stakeholders to foster organized cancer screenings uptake by underserved people. This action plan must match with the needs of people living in informal housing, and must be coordinated, suitable and feasible to implement, in terms of knowledge about people living in informal housing specificities and specific local collaborations
| Study group | Role | What they receive |
|---|---|---|
| ECEMSo intervention | This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group Receives: Behavioral: Knowledge mobilization to facilitate the structuring of health mediation | |
| Group 2 : No intervention | This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will not be implemented in this group. | |
| Group 3 : No intervention | This group is composed of health workers, social workers, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of health mediation on healthcare utilization in people living in informal housing (PLIH) in France
The difference in healthcare utilization by PLIH between groups 2 and group 3
Measured: At six months follow-up
Impact of the intervention on people living in informal housing (PLIH) uptake of organized cancer screening
The difference in organized cancer screening uptake (breast cancer, colorectal cancer, cervical cancer) between PLIH in group 1 and PLIH in group 2
Measured: At six months follow-up
Health mediation conditions required to foster utilization of healthcare services among people living in informal housing (PLIH) in France
The difference in organized cancer screening uptake (at 2 years since diagnosis for breast cancer and colorectal cancer, at 3 years since diagnosis for cervical cancer) between PLIH in group 1 and people living in informal housing in group 3
Measured: At six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Jan 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MediationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,041 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Martin-Fernandez, PhD, Principal investigator, Equipe Mérisp/PHARES, INSERM, BPH, U1219, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180746
- Sponsor's protocol ID
- CHUBX 2020/70
- Acronym
- ECEMSo
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Conditions of the Effects of Health Mediation on Underserved Populations' Healthcare Utilization
- ClinicalTrials.gov ID
- NCT06180746
- Acronym / sponsor ID
- ECEMSo / CHUBX 2020/70
- Conditions
- Mediation
- Keywords
- Healthcare utilization, Health mediation, Cancer screening, Complex intervention, realist evaluation, study protocol, underserved populations
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,041 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 22 Dec 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.
The investigators are conducting a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The ECEMSo study aims to identify the impact of health mediation on fostering healthcare utilization, in particular organized cancer screening uptake, by underserved populations living in informal housing in France.
Detailed description
Health mediation may foster underserved populations' healthcare utilization. No study to date has demonstrated its effectiveness in an experimental context. The ECEMSo case study aims to identify the impact of health mediation on fostering healthcare utilization - in particular organized cancer screening uptake - by underserved populations living in informal housing in France.
Grounded in a theory-based framework, the ECEMSo case study is a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The study population comprises various participant profiles including health mediators, health workers, social workers, people living in informal housing whom these professionals support, and other stakeholders concerned with underserved populations' health issues. Participants will be recruited in several French regions and divided into three mixed participant profile groups. In group 1, health mediation and the ECEMSo intervention will be implemented. This intervention comprises knowledge mobilization to facilitate the structuring of health mediation throughout France, and the development of an action plan to facilitate cancer screening uptake by people living in informal housing. In group 2, only health mediation will be implemented (i.e., no ECEMSo intervention). In group 3, neither health mediation nor the ECEMSo intervention will be implemented, but health and social workers will implement other health system navigation interventions.
Quantitative and qualitative data will be collected by interviewers through face-to-face questionnaires, interviews, observations, focus groups, and tracking tables of health mediation activities over six months. Data collection will be based on the health mediation conceptual framework.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECEMSo intervention | – | Behavioral: Knowledge mobilization to facilitate the structuring of health mediationThis group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group |
| Group 2 : No intervention | – | –This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will not be implemented in this group. |
| Group 3 : No intervention | – | –This group is composed of health workers, social workers, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Underserved Population
Key inclusion criteria (6 listed)
- Living on the streets, in a shanty house, squat or caravan
- Living in an area covered by one of care structures participating in the ECEMSo study
- Being over 18 years old
- Being able to understand the detailed information provided about the ECEMso study
- Being a health mediator, a health worker or a social worker belonging to one of the study's participation care structures
Key exclusion criteria (5 listed)
- Suffering from cognitive and/or psychiatric disorders
- Being under guardianship or curatorship
- Health mediators, heal workers, socials workers
- Inclusion criteria: Being an actor concerned or involved with the issues and needs of people living in informal housing
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 |
|---|---|---|
| Knowledge mobilization to facilitate the structuring of health mediationThe ECEMSo intervention involves knowledge mobilization to facilitate the structuring of health mediation throughout French territory, and the development of a co-designed effective action plan to facilitate cancer screening uptake by people living in informal housing. The action plan will, consider territorial specificities at the regional level. The ECEMSo project team will organize a seminar and three workshops. The aim of the seminar and workshops is to mobilize knowledge to facilitate i) the structuring of health mediation in the regions, and ii) the development of an action plan with health mediators and other stakeholders to foster organized cancer screenings uptake by underserved people. This action plan must match with the needs of people living in informal housing, and must be coordinated, suitable and feasible to implement, in terms of knowledge about people living in informal housing specificities and specific local collaborations | Behavioural | ECEMSo intervention |
Primary outcome
Impact of health mediation on healthcare utilization in people living in informal housing (PLIH) in France
Time frame: At six months follow-up
The difference in healthcare utilization by PLIH between groups 2 and group 3
Impact of the intervention on people living in informal housing (PLIH) uptake of organized cancer screening
Time frame: At six months follow-up
The difference in organized cancer screening uptake (breast cancer, colorectal cancer, cervical cancer) between PLIH in group 1 and PLIH in group 2
Health mediation conditions required to foster utilization of healthcare services among people living in informal housing (PLIH) in France
Time frame: At six months follow-up
The difference in organized cancer screening uptake (at 2 years since diagnosis for breast cancer and colorectal cancer, at 3 years since diagnosis for cervical cancer) between PLIH in group 1 and people living in informal housing in group 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Judith Martin-Fernandez, PhD principal investigator
Equipe Mérisp/PHARES, INSERM, BPH, U1219, University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediation, run by University Hospital, Bordeaux at 1 site in France.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Impact of health mediation on healthcare utilization in people living in informal housing (PLIH) in France (time frame: At six months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.