Evaluation of an Educational Hand Washing Intervention With a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 440
- 试验地点
- 23
- 主要终点
- Change in abscess prevalence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control Arm
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.
Intervention Arm
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.
干预措施: Educational hand hygiene intervention (Behavioral)
结局指标
主要结局
Change in abscess prevalence
时间窗: 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
次要结局
- MONO RUB Compliance, tolerance and satisfaction associated with the intervention (by measuring adverse events of MONO-RUB use)(Month 6)
- 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)