NCT07452926

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Study Progress37%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

February 16, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 16, 2026

Last Update Submit

February 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Risky consumption behaviours

    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

Study Arms (1)

DCR users

EXPERIMENTAL

There is only one arm in this study and it gathers DCR users who are going to be followed up.

Other: Self-reported questionnaire to monitor the consumption behaviors and sociodemographic characteristics

Interventions

Participants will complete a unique questionnaire covering different aspects: * 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 * sociodemographic and socioeconomic characteristics * drug-use profiles * level of social integration * quality of life * level of personal recovery * care needs

DCR users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • user of the DCR Link-Up in Bruxelles
  • agree to participate
  • sufficient command of either French or Dutch

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

March 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share