Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06131788
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-10-13
Brief Title:
Evaluation of an Educational Intervention on Abscesses in People Who Self-inject Drugs
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Evaluation of an Educational Hand Washing Intervention With a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAWA
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None