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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
440
The intervention combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB
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
...and 12 more locations
Change in abscess prevalence
The primary outcome will be the change in abscess prevalence between M0 and M6, compared between the control and intervention arms, measured from observed and self-declared data, collected from the injection-site photographs and the face-to-face injection-related SSTI questionnaire, respectively
Time frame: Month 0; Month 3; Month 6
Change in incidence of injection-related SSTI complications other than abscesses (e.g., cellulitis, skin ulcer, etc).
This will be assessed using the injection site photographs and the face-to-face injection-related SSTI questionnaire
Time frame: Month 0; Month 3; Month 6
Impact of the educational intervention on injection practices (use of sterile equipment, equipment sharing, and injection into a dangerous body site)
This will be determined using data from the three computer-assisted telephon interview (CATI) questionnaires. The EQ-5D-5L1 questionnaire is an European quality of life scale. The first part contains questions known as the "EQ-5D descriptive system", supplemented by a visual analogue scale known as the "EQ-5D VAS". It consists of a 20 cm, graduated from 0 to 100, on which the person must indicate how he or she rates his or her current state of health, 0 being the worst possible state and and 100 being the best.
Time frame: Month 0 ; Month 6
MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use)
This will be determined by mesuring adverse events, only in the intervention arm
Time frame: Month 6
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