Evaluation of an Educational Hand Washing Intervention With a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- People Who Inject Drugs
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- Change in abscess prevalence
- Status
- Not Yet Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in abscess prevalence
Time Frame: 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 Outcomes
- MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use)(Month 6)
- Change in incidence of injection-related SSTI complications other than abscesses (e.g., cellulitis, skin ulcer, etc).(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)(Month 0 ; Month 6)