- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07452926
Research and Evaluation of Link-Up, DCR in Brussels
Research and Evaluation of Link-Up, Drug Consumption Room in Brussels
Link-Up is the second Safer Consumption Room (SCMR) to open in the Brussels-Capital Region. SCMRs are public health facilities designed for people who use drugs mainly in public places. They are hygienically safe spaces where users can safely consume the products they have acquired elsewhere without moral judgment, under the supervision of specially trained professional staff. It is a risk reduction facility. Before Link-Up, two other SCMRs were opened in Belgium, including one, GATE, in the Brussels region. These first two SCMRs are currently undergoing scientific evaluation as part of the REVE-DROOM project (approved by the CEHF (2024/28MAI/276, on 06/18/2024) of the "Drugs" research program funded by BELSPO (Federal Science Policy). The present project aims to replicate the study of the effects associated with the use of SCMRs on users, as implemented in the evaluation system currently underway at GATE in the new SCMR, Link-Up, with a view to also evaluating its effects. The RELINK study is being conducted at the request of Iriscare, the bicommunal social protection OIP (Public Interests Organization) of the Brussels-Capital Region.
It is a study based on a natural experiment (i.e., all Link-Up users who agree to participate in the study will be included) and measures various indicators concerning them. The measured indicators primarily concern risky consumption practices (injection, consumption in public spaces, reuse and/or sharing of consumption equipment, and other practices that endanger the health of people who use drugs). As secondary effects, the measures concern the sociodemographic and socioeconomic characteristics of the user population, drug-use profiles, level of social integration, quality of life, level of personal recovery, and care needs.
The analysis of these various indicators will make it possible to describe the profile of Link-up SCS users and to compare it with that of GATE users. In addition, the study design allows for an extension to conduct a cohort follow-up and, therefore, to measure changes associated with the use of the SCS service.
The current study aims for a sample of at least 250 people recruited within the service. Indicator measurement is carried out using a questionnaire administered with the assistance of the research team and supported by SCS staff. The questionnaire consists of various scales validated in the scientific literature and already used in the REVE-DROOM study.
Given the similarity of the proposed Link-Up system with the one implemented at GATE, the results of the two Brussels SCSs will be the subject of a comparative analysis.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- user of the DCR Link-Up in Bruxelles
- agree to participate
- sufficient command of either French or Dutch
Exclusion Criteria:
- Refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DCR users
There is only one arm in this study and it gathers DCR users who are going to be followed up.
|
Participants will complete a unique questionnaire covering different aspects:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risky consumption behaviours
Time Frame: Throughout the entire study, during approximately 6 months
|
The questionnaire concerns different aspects of consumption behaviors (consumption mode, in public spaces, reuse and/or sharing of consumption equipment,...) and also sociodemographic and socioeconomic characteristics of the user population, level of social integration, quality of life, level of personal recovery, and care needs
|
Throughout the entire study, during approximately 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RELINK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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