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Evaluation of an Educational Intervention on Abscesses in People Who Self-inject Drugs

NCT06131788 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-05-12

No results posted yet for this study

Summary

The goal of this cluster randomised controlled trial (cRCT) is to to evaluate the effectiveness of an educational intervention combining training in hand-washing with the supply of MONO-RUBs on the reduction of skin abscesses (both observed and self-reported) in people who inject drugs (PWID).

The main questions it aims to answer are:

* does an educational intervention change the incidence of injection-related skin and soft tissue infection (SSTI) like abscesses in PWID?
* does the educational hand-washing intervention improve injection practices in terms of hand-hygiene in PWID?

According to cluster randomisation, PWID will be assigned to:

* Standard harm reduction (HR) services to reduce abscesses plus an educational hand-washing intervention (intervention arm)
* Standard HR services only (control arm)

To measure the effectiveness of the educational hand-washing intervention, the primary outcome will be the reduction in abscess prevalence compared in both groups. Statistical analyses for the primary outcome will involve comparing the reduction in abscess prevalence in the intervention arm with that in the control arm. This prevalence will be measured from observed and self-declared data, collected from the injection-site photographs and the face-to-face injection-related SSTI questionnaire, respectively.

Conditions

  • People Who Inject Drugs

Interventions

BEHAVIORAL

Educational hand hygiene intervention

The intervention combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB

Sponsors & Collaborators

  • AIDES

    collaborator UNKNOWN

  • Nouvelle Aube

    collaborator UNKNOWN

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Perrine ROUX, PhD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-02-20
Completion
2026-02-20

Countries

  • France

Study Locations

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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 NCT06131788 on ClinicalTrials.gov