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People Who Inject DrugsHAWANCT06131788

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

A study testing Educational hand hygiene intervention in people with People Who Inject Drugs, run by Institut National de la Santé Et de la Recherche Médicale, France at 22 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
People Who Inject Drugs
What is being tested?
Educational hand hygiene intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
22 sitesFrance
Study dates
1 Dec 2025to 20 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • AIDES

    Angoulême, 16000

  • AIDES

    Avignon, 84000

  • AIDES

    Besançon, 25000

  • AIDES

    Bourg-en-Bresse, 01000

  • AIDES

    Chartres, 28000

  • AIDES

    Clermont-Ferrand, 63000

  • AIDES

    La Rochelle, 17000

  • AIDES

    Laval, 53000

  • AIDES

    Lille, 59000

  • AIDES

    Limoges, 87000

  • AIDES

    Mulhouse, 68200

  • AIDES

    Nevers, 58000

  • AIDES

    Nîmes, 30000

  • AIDES

    Niort, 79000

  • AIDES

    Paris, 75002

  • AIDES

    Pau, 64000

  • AIDES

    Poitiers, 86000

  • AIDES

    Rennes, 35000

  • AIDES

    Rouen, 76000

  • AIDES

    Toulon, 83000

  • AIDES

    Toulouse, 31000

  • AIDES

    Tours, 37000

Other trials in France

About this study

Official title: 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:

Read more
  • 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.

Being tested
Educational hand hygiene intervention
Keywords
Harm Reduction, Soft Skin and Tissues Infections, Community-Based Participatory Research
Medical subject headings
Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational hand hygiene interventionBehavioural

    The intervention combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB

Study groups in NCT06131788
Study groupRoleWhat they receive
Intervention ArmActive comparatorThe 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.
Receives: Behavioral: Educational hand hygiene intervention
Control ArmNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Month 0; Month 3; Month 6

Secondary outcomes (3)

  1. 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

    Measured: Month 0; Month 3; Month 6

  2. 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.

    Measured: Month 0 ; Month 6

  3. 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

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start1 Dec 2025
  3. Primary completion20 Feb 2026
  4. Study completion20 Feb 2026

Why it stopped: As the research did not start within two years of the CPP's approval being granted, it is automatically considered to have expired for the CPP on the submission platform.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131788
Sponsor's protocol ID
C22-61
Acronym
HAWA
Status last verified
May 2026
First submitted
13 Oct 2023
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Hrycko A, Mateu-Gelabert P, Ciervo C, Linn-Walton R, Eckhardt B. Severe bacterial infections in people who inject drugs: the role of injection-related tissue damage. Harm Reduct J. 2022 May 2;19(1):41. doi: 10.1186/s12954-022-00624-6.

    PubMed 35501854

  • Dahlman D, Hakansson A, Kral AH, Wenger L, Ball EL, Novak SP. Behavioral characteristics and injection practices associated with skin and soft tissue infections among people who inject drugs: A community-based observational study. Subst Abus. 2017 Jan-Mar;38(1):105-112. doi: 10.1080/08897077.2016.1263592. Epub 2016 Nov 29.

    PubMed 27897966

  • Sartelli M, Guirao X, Hardcastle TC, Kluger Y, Boermeester MA, Rasa K, Ansaloni L, Coccolini F, Montravers P, Abu-Zidan FM, Bartoletti M, Bassetti M, Ben-Ishay O, Biffl WL, Chiara O, Chiarugi M, Coimbra R, De Rosa FG, De Simone B, Di Saverio S, Giannella M, Gkiokas G, Khokha V, Labricciosa FM, Leppaniemi A, Litvin A, Moore EE, Negoi I, Pagani L, Peghin M, Picetti E, Pintar T, Pupelis G, Rubio-Perez I, Sakakushev B, Segovia-Lohse H, Sganga G, Shelat V, Sugrue M, Tarasconi A, Trana C, Ulrych J, Viale P, Catena F. 2018 WSES/SIS-E consensus conference: recommendations for the management of skin and soft-tissue infections. World J Emerg Surg. 2018 Dec 14;13:58. doi: 10.1186/s13017-018-0219-9. eCollection 2018.

    PubMed 30564282

  • Allegranzi B, Tartari E, Pittet D. "Seconds save lives - clean your hands": the 5 May 2021 World Health Organization SAVE LIVES: Clean Your Hands campaign. J Hosp Infect. 2021 May;111:1-3. doi: 10.1016/j.jhin.2021.03.001. Epub 2021 Mar 7.

    PubMed 33691160

  • Rosenfeld J, Berggren R, Frerichs L. A Review of the Community Health Club Literature Describing Water, Sanitation, and Hygiene Outcomes. Int J Environ Res Public Health. 2021 Feb 15;18(4):1880. doi: 10.3390/ijerph18041880.

    PubMed 33671972

  • Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.

    PubMed 32830383

  • Phillips KT. Barriers to practicing risk reduction strategies among people who inject drugs. Addict Res Theory. 2016;24(1):62-68. doi: 10.3109/16066359.2015.1068301. Epub 2015 Jul 21.

    PubMed 27499724

  • Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, Stone J, Cunningham EB, Trickey A, Dumchev K, Lynskey M, Griffiths P, Mattick RP, Hickman M, Larney S. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health. 2017 Dec;5(12):e1192-e1207. doi: 10.1016/S2214-109X(17)30375-3. Epub 2017 Oct 23.

    PubMed 29074409

  • Mezaache S, Briand-Madrid L, Rahni L, Poireau J, Branchu F, Moudachirou K, Wendzinski Y, Carrieri P, Roux P. A two-component intervention to improve hand hygiene practices and promote alcohol-based hand rub use among people who inject drugs: a mixed-methods evaluation. BMC Infect Dis. 2021 Feb 25;21(1):211. doi: 10.1186/s12879-021-05895-1.

    PubMed 33632143

  • Roux P, Le Gall JM, Debrus M, Protopopescu C, Ndiaye K, Demoulin B, Lions C, Haas A, Mora M, Spire B, Suzan-Monti M, Carrieri MP. Innovative community-based educational face-to-face intervention to reduce HIV, hepatitis C virus and other blood-borne infectious risks in difficult-to-reach people who inject drugs: results from the ANRS-AERLI intervention study. Addiction. 2016 Jan;111(1):94-106. doi: 10.1111/add.13089. Epub 2015 Sep 28.

    PubMed 26234629

  • Mezaache S, Protopopescu C, Debrus M, Morel S, Mora M, Suzan-Monti M, Rojas Castro D, Carrieri P, Roux P. Changes in supervised drug-injecting practices following a community-based educational intervention: A longitudinal analysis. Drug Alcohol Depend. 2018 Nov 1;192:1-7. doi: 10.1016/j.drugalcdep.2018.07.028. Epub 2018 Sep 5.

    PubMed 30195241

  • Tschudin-Sutter S, Sepulcri D, Dangel M, Ulrich A, Frei R, Widmer AF. Simplifying the World Health Organization Protocol: 3 Steps Versus 6 Steps for Performance of Hand Hygiene in a Cluster-randomized Trial. Clin Infect Dis. 2019 Aug 1;69(4):614-620. doi: 10.1093/cid/ciy948.

    PubMed 30395180

  • Pires D, Soule H, Bellissimo-Rodrigues F, Gayet-Ageron A, Pittet D. Hand Hygiene With Alcohol-Based Hand Rub: How Long Is Long Enough? Infect Control Hosp Epidemiol. 2017 May;38(5):547-552. doi: 10.1017/ice.2017.25. Epub 2017 Mar 7.

    PubMed 28264743

  • Balhan L, Aubert M, Lacoux C, Grau N, Levy J, Stefanowski ML, Perreaut L, Sagaon-Teyssier L, Deuffic-Burban S, Cousien A, Michels D, Costa M, Roux P. A hand-washing community-based educational intervention to reduce abscess incidence among people who inject drugs: a cluster randomised controlled clinical trial protocol (the HAWA study protocol). BMC Public Health. 2024 Oct 17;24(1):2858. doi: 10.1186/s12889-024-20299-x.

    PubMed 39420312

Questions about this trial

What is this clinical trial studying?

A study testing Educational hand hygiene intervention in people with People Who Inject Drugs, run by Institut National de la Santé Et de la Recherche Médicale, France at 22 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in abscess prevalence (time frame: Month 0; Month 3; Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131788, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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