People Who Inject Drugs
Conditions
Keywords
Harm Reduction, Soft Skin and Tissues Infections, Community-Based Participatory Research
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.
Interventions
BEHAVIORALEducational hand hygiene intervention
The intervention combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
AIDES
Nouvelle Aube
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPerrine ROUX, PhD
Institut National de la Santé Et de la Recherche Médicale, France
Outcome results
None listed