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

Institut National de la Santé Et de la Recherche Médicale, France

Status: Not yet enrolling

Conditions: People Who Inject Drugs

Treatments: Behavioral: Educational hand hygiene intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06131788

C22-61

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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440 participants in 2 patient groups

Intervention Arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Educational hand hygiene intervention

Control Arm

No Intervention group

Description:

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.