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

NCT06131788 | Not Yet Recruiting

• 1 other identifier: C22-61
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 22

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.

Conditions

People Who Inject Drugs

Keywords

Harm Reduction; Soft Skin and Tissues Infections; Community-Based Participatory Research

Outcome Measures

Primary Outcomes (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

  Month 0; Month 3; Month 6

Secondary Outcomes (3)

• Change in incidence of injection-related SSTI complications other than abscesses (e.g., cellulitis, skin ulcer, etc).

  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)

  Month 0 ; Month 6

• MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use)

  Month 6

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

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

Control Arm

NO 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.

Interventions

Educational hand hygiene intervention BEHAVIORAL

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• AIDES: collaborator
• Nouvelle Aube: collaborator

Study Sites (22)

AIDES

Angoulême, 16000, France

Location

AIDES

Avignon, 84000, France

Location

AIDES

Besançon, 25000, France

Location

AIDES

Bourg-en-Bresse, 01000, France

Location

AIDES

Chartres, 28000, France

Location

AIDES

Clermont-Ferrand, 63000, France

Location

AIDES

La Rochelle, 17000, France

Location

AIDES

Laval, 53000, France

Location

AIDES

Lille, 59000, France

Location

AIDES

Limoges, 87000, France

Location

AIDES

Mulhouse, 68200, France

Location

AIDES

Nevers, 58000, France

Location

AIDES

Niort, 79000, France

Location

AIDES

Nîmes, 30000, France

Location

AIDES

Paris, 75002, France

Location

AIDES

Pau, 64000, France

Location

AIDES

Poitiers, 86000, France

Location

AIDES

Rennes, 35000, France

Location

AIDES

Rouen, 76000, France

Location

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Toulon, 83000, France

Location

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Toulouse, 31000, France

Location

AIDES

Tours, 37000, France

Location

Related Publications (14)

• 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.

  PMID: 35501854 BACKGROUND

• 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.

  PMID: 27897966 BACKGROUND

• 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.

  PMID: 30564282 BACKGROUND

• 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.

  PMID: 33691160 BACKGROUND

• 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.

  PMID: 33671972 BACKGROUND

• 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.

  PMID: 32830383 BACKGROUND

• 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.

  PMID: 27499724 BACKGROUND

• 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.

  PMID: 29074409 BACKGROUND

• 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.

  PMID: 33632143 BACKGROUND

• 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.

  PMID: 26234629 BACKGROUND

• 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.

  PMID: 30195241 BACKGROUND

• 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.

  PMID: 30395180 BACKGROUND

• 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.

  PMID: 28264743 BACKGROUND

• 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.

  PMID: 39420312 DERIVED

MeSH Terms

Conditions

Harm Reduction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Perrine ROUX, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Perrine ROUX, PhD

CONTACT

04 13 73 22 78; perrine.roux@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 14, 2023
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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).

Locations

FR (22)