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

Not Applicable

Not yet recruiting

• Conditions: People Who Inject Drugs
• Interventions: Behavioral: Educational hand hygiene intervention

• Registration Number: NCT06131788
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Study Start: 2025-06
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• over 18 years old,
• French-speaking,
• reporting to have injected drugs at least once during the previous week,
• and providing free and informed consent to participate.

Exclusion Criteria

• not regularly going to the participating HR centre in the relevant city,
• having an alcohol and/or alcohol-based hand rub (ABHR) excipient intolerance/allergy,
• being under legal protection (guardianship or judicial protection),
• current pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Educational hand hygiene intervention	The intervention among people who inject drugs (PWID) from the intervention arm consist in : i) educational hand washing training ("fingertips first" model), ii) supply of single use alcohol-based hand rub (called MONO-RUB). Only staff from the 11 harm reduction (HR) centres in the intervention arm will be trained in the educational hand-washing intervention.

Primary Outcome Measures

Name	Time	Method
Change in abscess prevalence	Month 0; Month 3; Month 6	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

Secondary Outcome Measures

Name	Time	Method
MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use)	Month 6	This will be determined by mesuring adverse events, only in the intervention arm
Change in incidence of injection-related SSTI complications other than abscesses (e.g., cellulitis, skin ulcer, etc).	Month 0; Month 3; Month 6	This will be assessed using the injection site photographs and the face-to-face injection-related SSTI questionnaire
Impact of the educational intervention on injection practices (use of sterile equipment, equipment sharing, and injection into a dangerous body site)	Month 0 ; Month 6	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.

Trial Locations

Locations (1)

AIDES; 🇫🇷 Tours, France