Evaluation of an Educational Hand Washing Intervention With a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs
| Registry | NCT06131788, acronym HAWA |
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| Status | Withdrawn - As the research did not start within two years of the CPP's approval being granted, it is automatically considered to have expired for the CPP on the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. |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, prevention |
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| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France (Other gov); collaborators: AIDES, Nouvelle Aube |
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| Conditions | People Who Inject Drugs |
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| Interventions | Educational hand hygiene intervention (Behavioral) |
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| Dates | start 2025-12-01, primary completion 2026-02-20, completion 2026-02-20, first posted 2023-11-14, last updated 2026-05-12 |
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| Locations | 22 sites in France |
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Related Papers Related Patents Related Grants Related Experts
All trials for People Who Inject Drugs All trials of Educational hand hygiene intervention
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Intervention Arm | Active comparator | Behavioral: Educational hand hygiene intervention | 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. |
| 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. |
- 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
+Outcome measures
Primary outcomes
- Change in abscess prevalence [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
Secondary outcomes
- Change in incidence of injection-related SSTI complications other than abscesses (e.g., cellulitis, skin ulcer, etc). [Month 0; Month 3; Month 6]: This will be assessed using the injection site photographs and the face-to-face injection-related SSTI questionnaire
- 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]: 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.
- MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use) [Month 6]: This will be determined by mesuring adverse events, only in the intervention arm
+Eligibility
Sex: All, ages: 18 Years to any, 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.
+Locations (22)
| Facility | City | Country | Status |
|---|
| AIDES | Angoulême | France | |
| AIDES | Avignon | France | |
| AIDES | Besançon | France | |
| AIDES | Bourg-en-Bresse | France | |
| AIDES | Chartres | France | |
| AIDES | Clermont-Ferrand | France | |
| AIDES | La Rochelle | France | |
| AIDES | Laval | France | |
| AIDES | Lille | France | |
| AIDES | Limoges | France | |
| AIDES | Mulhouse | France | |
| AIDES | Nevers | France | |
| AIDES | Niort | France | |
| AIDES | Nîmes | France | |
| AIDES | Paris | France | |
| AIDES | Pau | France | |
| AIDES | Poitiers | France | |
| AIDES | Rennes | France | |
| AIDES | Rouen | France | |
| AIDES | Toulon | France | |
| AIDES | Toulouse | France | |
| AIDES | Tours | France | |
+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28264743
- Results publication: 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
+Investigators
- Perrine ROUX, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France