hands4health: A Multi-component Intervention on Hand Hygiene in Primary Health Care Facilities in Burkina Faso and Mali

NCT05946980 | Completed

• 1 other identifier: 7F-l 0345.03.01
• Study Type: interventional
• Target: 309
• Locations: 2 countries
• Sites: 2

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.).

Conditions

Hand Hygiene Behavior; Hand Hygiene Effectiveness

Keywords

Hand Hygiene; Behavior Change; Primary Health Care; Primary Schools; Humanitarian Emergency

Outcome Measures

Primary Outcomes (1)

• Change in handwashing practice with soap and water or hand sanitizer in the 5 critical moments of WHO

  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

  Up to 12 months

Secondary Outcomes (8)

• Change in self reported handwashing practice

  Up to 12 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

Other Outcomes (7)

• Covariate 1: Age (age groups)

  Up to 12 months

• Covariate 2: Education levels

  Up to 12 months

• Covariate 3: Sex

  Up to 12 months

Study Arms (2)

Intervention arm for primary health care facilities in Mali and Burkina Faso

EXPERIMENTAL

This arm receives the multi-component intervention for primary health care facilities described under interventions

Other: Multi-component hand hygiene intervention in primary health care facilities

Control arm for primary health care facilities in Mali and Burkina Faso

NO INTERVENTION

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.

Interventions

Multi-component hand hygiene intervention in primary health care facilities OTHER

Intervention facilities will receive (1), two novel Gravit'eau (https://www.graviteau.ch/) handwashing systems which are locally produced. These systems recycle water for handwashing with gravity through a membrane filter without electricity up to a month. Facilities also receive (2), a behavior change intervention lead by RANAS (https://www.ranasmosler.com/ranas), expert psychologist for behavior change in WASH. They will also receive (3), support to implement WASH FIT (https://washfit.org/#/) in their facilities, a tool developed by WHO to sustainably maintain and improve WASH infrastructure in health care facilities. Additionally, we are recruiting a "circuit rider" responsible for the regular inspection and maintenance of WASH infrastructure. (4), the facilities will receive support for regular water chlorination.

Also known as: Gravit'eau handwashing system, RANAS behavior change, WASH FIT, Chlorination support

Intervention arm for primary health care facilities in Mali and Burkina Faso

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 3.
• Minimum age of 18 years
• HCWs, men and women, who are in direct (body) contact with the patients
• 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
• HCWs of the intervention facilities
• Minimum age of 18 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Terre des Hommes: collaborator
• University of Applied Sciences and Arts Northwestern Switzerland: collaborator

Study Sites (2)

24 community health centers (CSPS)

Dédougou, Dédougou, Boromo, Burkina Faso

Location

24 community health centers (CSCOMs)

Ségou, Markala, Macina, Ségou, Tominian, Mali

Location

Related Publications (1)

• Galli A, Ma'ani Abuzahra Y, Banziger C, Ballo A, Friedrich MND, Gross K, Harter M, Hattendorf J, Peter M, Tamas A, Owen BN, Winkler MS. Assessing the Effectiveness of a Multicomponent Intervention on Hand Hygiene and Well-Being in Primary Health Care Centers and Schools Lacking Functional Water Supply in Protracted Conflict Settings: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 3;13:e52959. doi: 10.2196/52959.

  PMID: 38569182 DERIVED

Related Links

• Hands4health project website
• Gravit'eau Website
• RANAS Ltd. Website
• WASH FIT Website

Study Officials

• Mirko S. Winkler, Prof.

  Swiss Tropical and Public Health Institute and University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Lab technicians will be masked for hand-rinse sample processing and analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized multi-center controlled trial In each country there is an intervention and control group. The control group will not receive anything until the end of data collection. Afterwards they will receive the intervention as well, improved if needed.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 14, 2023
• Study Start: January 30, 2023
• Primary Completion: March 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: As our partner Terre des hommes actually collects the data in the field, they will have access to the IPD in real time in order to guaranty quality control. Other consortium members can receive the coded IPD if needed upon request as soon as the data is complete and cleaned.
• Access Criteria: Internally: Data collected through ODK or KoboToolbox are stored on the ODK central server, to which the data collecting organization (Tdh, CESVI), RANAS and Swiss TPH have direct access. Other consortium members wishing to have access to data can directly contact someone with access to the server and ask them for the coded data. Externally: The use of data by third parties needs to be approved in writing by all consortium members.

Locations

MA (1); BU (1)