Clinical trial NCT06131788: Evaluation of an Educational Intervention on Abscesses in People Who Self-inject Drugs
Official title: Evaluation of an Educational Hand Washing Intervention with a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: People Who Inject Drugs
Keywords: Harm Reduction
Soft Skin and Tissues Infections
Community-Based Participatory Research
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: AIDES
name: Nouvelle Aube
First posted: 2023-11-14
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in abscess prevalence
timeFrame: Month 0; Month 3; Month 6
Secondary outcomes:
measure: Change in incidence of injection-related SSTI complications other than abscesses (e.g., cellulitis, skin ulcer, etc).
timeFrame: Month 0; Month 3; Month 6
measure: Impact of the educational intervention on injection practices (use of sterile equipment, equipment sharing, and injection into a dangerous body site)
timeFrame: Month 0 ; Month 6
measure: MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use)
timeFrame: Month 6
Other outcomes:
Locations:
city: Angoulême
country: France
facility: AIDES
city: Avignon
country: France
facility: AIDES
city: Besançon
country: France
facility: AIDES
city: Bourg-en-Bresse
country: France
facility: AIDES
city: Chartres
country: France
facility: AIDES
city: Clermont-Ferrand
country: France
facility: AIDES
city: La Rochelle
country: France
facility: AIDES
city: Laval
country: France
facility: AIDES
city: Lille
country: France
facility: AIDES
city: Limoges
country: France
facility: AIDES
city: Mulhouse
country: France
facility: AIDES
city: Nevers
country: France
facility: AIDES
city: Niort
country: France
facility: AIDES
city: Nîmes
country: France
facility: AIDES
city: Paris
country: France
facility: AIDES
city: Pau
country: France
facility: AIDES
city: Poitiers
country: France
facility: AIDES
city: Rennes
country: France
facility: AIDES
city: Rouen
country: France
facility: AIDES
city: Toulon
country: France
facility: AIDES
city: Toulouse
country: France
facility: AIDES
city: Tours
country: France
facility: AIDES
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Perrine ROUX, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.