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

Study Overview
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Brief Summary
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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
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Evaluation of an Educational Hand Washing Intervention With a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs

Conditions
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People Who Inject Drugs

Intervention / Treatment
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* Behavioral: Educational hand hygiene intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The HAWA study is a community-based participatory research conducted in 22 harm reduction centres in France which will be cluster randomised to determine those who will propose the intervention (standard services + brief education to hand washing + MONO-RUB distribution) and those who will be the control group (standard services). After randomization, each group of HR centres will include 220 PWID within an inclusion period of 12 months and a follow-up period of 6 months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Arm<br>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. | Behavioral: Educational hand hygiene intervention<br>* The intervention combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB<br>|
| No Intervention: Control Arm<br>The 11 control arm HR centres will be the placebo group. People who inject drugs (PWID) in this group will receive standard HR services, including to reduce abscesses if necessary. MONO-RUBs will not be made available in these HR centres during the intervention period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in abscess prevalence | The primary outcome will be the reduction 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 | Month 0; Month 3; Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Month 0; Month 3; Month 6 | 
| impact in injection practices in terms of hand-hygiene directly linked to the educational hand-washing intervention | This will be determined using data from the three computer-assisted telephon interview (CATI) questionnaires and by assessing the use of sterile equipment, equipment sharing, and injection into a dangerous body site | Month 0 ; Month 6 | 
| MONO-RUB use compliance | This will be determined by mesuring adverse events , only in the intervention arm | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Harm Reduction, Soft Skin and Tissues Infections, Community-Based Participatory Research