hands4health: Hand Hygiene, Water Quality and Sanitation in Primary Health Care Not Connected to Functional Water Supply System: a Cluster-randomized Controlled Trial in Mali and Burkina Faso
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Change in handwashing practice with soap and water or hand sanitizer in the 5 critical moments of WHO
研究概览
简要总结
The goal of this cluster randomized controlled trial is to assess the effectiveness of the hands4health multi-component hand hygiene intervention in patients and health care providers in primary health care facilities in Burkina Faso and Mali. The main question it aims to answer is:
* Can the hands4health multi-component hand hygiene intervention have a positive effect on the health determinants of our study population? Participants will be structurally observed for assessing their handwashing behavior, answer to a self-reported RANAS survey and provide a hand-rinse sample at base line, follow-up and end line. In addition specific pre-defined health outcomes and absenteeism will be tracked with a journal approach in the facilities. Intervention facilities will receive a Gravit'eau handwashing system, a RANAS behaviour change intervention, WASH FIT support, and chlorination support. Control facilities will receive nothing at the beginning, but once all of the data is collected, they will receive the same intervention as the intervention facilities have received. Researchers will compare the intervention and control groups to see if the hands4health intervention has any positive effects on the populations health determinants (e.g. handwashing behavior, perceptions towards hand hygiene, perceived risks, etc.).
详细描述
The overall project will follow an multi-center cluster-randomized controlled trial (cRCT) design. Prior to this study, the Facility and Evaluation Tool for WASH in Institutions (FACET) has been used to assess the WASH infrastructure of the primary health care facilities (PHCFs) in the study regions. From these PHCFs a subsample was identified which fulfils certain inclusion criteria (see Eligibility).
This subsample was handed over to the local Terre des hommes (Tdh) collaborators who carefully assessed the security situation around the facilities. The Tdh collaborators then chose 24 facilities which are most probable to still be accessible for data collection within the next year. These 24 PHCFs will then be distributed into two arms (intervention vs. control) with stratified randomization using computer-generated randomization code provided by an statistician not involved in any field activities. The intervention arm will receive the full intervention package (see multi-component intervention in health care facilities). The control arm will receive nothing for the duration of the intervention (9 months). Afterwards they will receive the same intervention package with potential improvements identified in the former intervention group.
In the chosen PHCFs all health care workers (HCWs) present at the day of data collection who fulfil the inclusion criteria will be asked to participate in the study. We aim to have as many of the HCWs in all of the Modules 1 and 3 as possible. For Module 2, only a maximum of 10 HCWs per facility will be observed.
The following modules will be used in the cRCT and the overall project to assess the effectiveness of the h4h multi-component intervention: (i) Module 1: Combined RANAS and KAP survey, (ii) Module 2: Structured handwashing observations, (iii) Module 3: Microbiological analysis of hand rinse samples, (iv) Module 4: Diary approach for pre-defined health outcomes, (v) Module 5: Focus Group Discussions (FGDs) and (vi) Module 6: Key informant interviews (KIIs).
The Swiss TPH assessed the health care worker's understanding of hygiene and expected positive and negative impacts of the intervention with Gravit'eau with focus group discussions (FGDs) in 18 facilities in Mali and 9 facilities in Burkina Faso (more facilities are still being investigated). Local collaborators from Tdh and the regional ministries of health were involved from the study's kick-off meeting onwards and are regularly being consulted in bi-weekly meetings and additional ToC workshops led by Skat Foundation. The data collection methods for each module will be described in further detail:
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
- None
盲法说明
Lab technicians will be masked for hand-rinse sample processing and analysis.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in handwashing practice with soap and water or hand sanitizer in the 5 critical moments of WHO
时间窗: Up to 12 months
The primary outcome is the number of times a participant performs good handwashing practice with soap or hand disinfectant at critical moments assessed by structured handwashing observations over an hour per unit in each health care facility. The number of critical moments serves as denominator. Critical moments are defined by the WHO as: i) Before touching a patient ii) Before clean/aseptic procedures iii) After risk/exposure to body fluids iv) After touching a patient v) After touching a patient's surroundings
次要结局
- Change in self reported handwashing practice(Up to 12 months)
- Experimental 4: Sum of incidences of neonatal sepsis per health care facility(Up to 8 months)
- Experimental 5: Sum of incidences of umbilical cord infections per health care facility(Up to 8 months)
- Health care facilities: change in log-transformed number of total coliforms and E.coli(Up to 12 months)
- Experimental 1: Sum of incidences of absenteeism of work due to illness in health care workers(Up to 8 months)
- Experimental 2: Sum of incidences of maternal mortality per health care facility(Up to 8 months)
- Experimental 3: Sum of incidences of neonatal mortality per health care facility(Up to 8 months)
- Experimental 6: Sum of incidences of wound infection after stitching or surgical procedures per health care facility(Up to 8 months)