An interventional study of Educational hand hygiene intervention in People Who Inject Drugs, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Withdrawn at 22 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Prevention
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:
According to cluster randomisation, PWID will be assigned to:
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.
115 studies on the registry are indexed under Harm Reduction; 39 are open to participants now.
Browse Harm Reduction studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
The intervention combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB
Change in abscess prevalence
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
Time frame: Month 0; Month 3; Month 6
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
Time frame: 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)
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.
Time frame: Month 0 ; Month 6
MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use)
This will be determined by mesuring adverse events, only in the intervention arm
Time frame: Month 6
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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.
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).
Ran from Dec 2025 to primary completion in Feb 2026, 2 months.
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This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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