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

People Who Inject Drugs Clinical Trial

— HAWA  

Official title:

Evaluation of an Educational Hand Washing Intervention With a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06131788
• Other study ID #: C22-61
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2026

Study information

• Verified date: July 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Perrine ROUX, PhD
• Phone: 04 13 73 22 78
• Email: perrine.roux[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abscess
• People Who Inject Drugs

Intervention

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

Locations

Country	Name	City	State
France	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	Nîmes
France	AIDES	Niort
France	AIDES	Paris
France	AIDES	Pau
France	AIDES	Poitiers
France	AIDES	Rennes
France	AIDES	Rouen
France	AIDES	Toulon
France	AIDES	Toulouse
France	AIDES	Tours

Sponsors (4)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	AIDES, IAME INSERM UMR1137, Nouvelle Aube

Country where clinical trial is conducted

France, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. Erratum In: Lancet Glob Health. 2017 Nov 15;: — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Month 0; Month 3; Month 6
Secondary	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.	Month 0 ; Month 6
Secondary	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	Month 6