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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 309
- Locations
- 2
- Primary Endpoint
- Change in handwashing practice with soap and water or hand sanitizer in the 5 critical moments of WHO
Study Overview
Brief Summary
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.).
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Lab technicians will be masked for hand-rinse sample processing and analysis.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •in health care facilities:
- •Study participants will be health care workers of the primary health care facilities (PHCFs) which were chosen to be included in this study. PHCFs were chosen based on accessibility for the study teams, not having a water source directly connected to the building of the facility, having a maternity ward, having at least five employees and being impacted by conflict. All of the HCWs who are present in the PHCFs of the day of data collection will be invited to participate in the project for Modules 1 and
- •Inclusion criteria Modules 1-3: HCWs must fulfil all the inclusion criteria:
- •Minimum age of 18 years
- •HCWs, men and women, who are in direct (body) contact with the patients
- •During the handwashing observations, HCWs will consult with patients. In order to protect patients, they must meet these inclusion criteria for an observer to be allowed into the consultation room with them:
- •Minimum age of 18 years or be accompanied by a legal guardian 18 years or older.
- •Going to the SSE for a physical examination, injections/vaccinations or blood test.
- •Oral consent to enter the room with them
- •Inclusion criteria Module 4: As the data will be collected on the health care facility level, all facilities in the project will be included.
- •Inclusion criteria Module 5:
- •HCWs of the intervention facilities
- •Minimum age of 18 years
- •Inclusion criteria Module 6:
- •The participant needs to be:
- •a stakeholder within the community, state, region or country of the intervention who's position is related in any way to WASH in HCFs
- •working in one of the intervention PHCFs. They do not need to be HCWs, they can also be hygiene technicians or in a leading position of the facilities.
- •Minimum age of 18 years
Exclusion Criteria
- •Exclusion criteria Modules 1-3: HCW participants must not fulfil any of the following exclusion criteria:
- •HCWs, whose primary occupation is not in the PHCF of the h4h project
- •Suffering from any skin conditions not allowing the HCW to use soap or alcoholic hand rub
- •Refusals to participate
- •Exclusion criteria Module 5: Refusals to participate.
- •Exclusion criteria Module 6: Refusals to participate
Arms & Interventions
Intervention arm for primary health care facilities in Mali and Burkina Faso
This arm receives the multi-component intervention for primary health care facilities described under interventions
Intervention: Multi-component hand hygiene intervention in primary health care facilities (Other)
Control arm for primary health care facilities in Mali and Burkina Faso
No intervention until the end of the cRCT. After completion of data collection, this arm will receive the same intervention as the intervention arm has received previously.
Outcomes
Primary Outcomes
Change in handwashing practice with soap and water or hand sanitizer in the 5 critical moments of WHO
Time Frame: 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
Secondary Outcomes
- 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)