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NOT YET RECRUITING
NCT06131788
NA

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

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

View on ClinicalTrials.gov

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.

Official title: Evaluation of an Educational Hand Washing Intervention With a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2025-12

Completion Date

2026-12

Last Updated

2025-09-19

Healthy Volunteers

Yes

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

Locations (22)

AIDES

Angoulême, France

AIDES

Avignon, France

AIDES

Besançon, France

AIDES

Bourg-en-Bresse, France

AIDES

Chartres, France

AIDES

Clermont-Ferrand, France

AIDES

La Rochelle, France

AIDES

Laval, France

AIDES

Lille, France

AIDES

Limoges, France

AIDES

Mulhouse, France

AIDES

Nevers, France

AIDES

Niort, France

AIDES

Nîmes, France

AIDES

Paris, France

AIDES

Pau, France

AIDES

Poitiers, France

AIDES

Rennes, France

AIDES

Rouen, France

AIDES

Toulon, France

AIDES

Toulouse, France

AIDES

Tours, France