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

May 7, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angoulême, France, 16000
        • AIDES
      • Avignon, France, 84000
        • AIDES
      • Besançon, France, 25000
        • AIDES
      • Bourg-en-Bresse, France, 01000
        • AIDES
      • Chartres, France, 28000
        • AIDES
      • Clermont-Ferrand, France, 63000
        • AIDES
      • La Rochelle, France, 17000
        • AIDES
      • Laval, France, 53000
        • AIDES
      • Lille, France, 59000
        • AIDES
      • Limoges, France, 87000
        • AIDES
      • Mulhouse, France, 68200
        • AIDES
      • Nevers, France, 58000
        • AIDES
      • Niort, France, 79000
        • AIDES
      • Nîmes, France, 30000
        • AIDES
      • Paris, France, 75002
        • AIDES
      • Pau, France, 64000
        • AIDES
      • Poitiers, France, 86000
        • AIDES
      • Rennes, France, 35000
        • AIDES
      • Rouen, France, 76000
        • AIDES
      • Toulon, France, 83000
        • AIDES
      • Toulouse, France, 31000
        • AIDES
      • Tours, France, 37000
        • AIDES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Arm

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
The intervention combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB
No Intervention: Control Arm
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
Time Frame: Month 0; Month 3; Month 6
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 of the educational intervention on injection practices (use of sterile equipment, equipment sharing, and injection into a dangerous body site)
Time Frame: 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.
Month 0 ; Month 6
MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use)
Time Frame: Month 6
This will be determined by mesuring adverse events, only in the intervention arm
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

AIDES
Nouvelle Aube

Investigators

  • Principal Investigator: Perrine ROUX, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Actual)

February 20, 2026

Study Completion (Actual)

February 20, 2026

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C22-61

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through the HaWa study may be provided to qualified researchers with academic interest in harm reduction for PWID. Data or samples shared will be coded, and deidentified. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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