Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946980
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-06-16
Brief Title:
hands4health A Multi-component Intervention on Hand Hygiene in Primary Health Care Facilities in Burkina Faso and Mali
Sponsor:
Swiss Tropical Public Health Institute
Organization:
Swiss Tropical Public Health Institute
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
h4h
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 Graviteau 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 eg handwashing behavior perceptions towards hand hygiene perceived risks etc
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 Graviteau 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 eg 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 workers understanding of hygiene and expected positive and negative impacts of the intervention with Graviteau 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 studys 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
Module 1 Combined RANAS and KAP survey The survey will be developed through the RANAS approach and will not only include attitude and belief questions but also target the underlying psychological factors postulated by the RANAS model that are important precursors for effective behaviour change If needed this survey will be enriched with additional questions to assess knowledge and self-reported handwashing practices of the participants The survey will be administered to HCWs three times in total as a baseline survey before the intervention package about two months after the intervention and about a year after the baseline survey with the software Open Data Kit ODK Central version 202231 on Android tablets
Module 2 Structured handwashing observations Structured handwashing observations are perceived as a gold standard method to assess handwashing behaviour Data from Module 1 and the observations can later be combined through a unique ID of the study participants The observations will be administered with HCWs three times at the same time points as the survey in Module 1
A trained observer from a Tdh team or the local ministry of health who normally works in the health care facilities with a different function will visit the facility under the pretence of their usual function They will be equipped with an observation tool and will follow a healthcare worker for a minimum of one hour at the peak time per PHCF unit for patient visits The observer will not declare that heshe is observing handwashing practices Consent will be obtained at a health care facility level from the director of the health care facility To avoid making patients feel uncomfortable during sensitive procedures such as giving birth only patient visits containing physical examination injection and blood sampling will be observed and the patients will be asked for their oral consent prior to entering a room with them
Module 3 Microbiological analysis of hand rinse samples Hand rinse samples of HCWs will be collected after the survey with a modified glove juice method as described by Pickering et al 2010 For the hand rinse sample collection the participants hand will be inserted into a 69-oz Whirl-Pak bag NASCO Corp Fort Atkinson WI filled with 350 mL of clean water Then the participant has to shake herhis hand in the water and rub herhis thumb and fingers together for 15 seconds Afterwards the data collector will massage the participants hand through the bag for another 15 seconds The participant will be provided with a paper towel to dry the hand once it is retrieved from the bag Afterwards the procedure will be repeated with the other hand
The Whirl-Pak bags containing the samples will be kept on ice in an isolation box and processed within 4 hours of sampling Membrane filtration will be used to detect colony-forming units CFUs of EColi and total coliforms In a field laboratory the content of the bags will be passed through a 47-mm-diameter 045 µm cellulose filter The filter paper will then be placed on growth media and incubated at 35C 05C for a duration of 24 hours for EColi and total coliforms 45 We plan to filter 100 mL per bag to detect CFUs of EColi and total coliforms The exact amount of mL will be established during piloting as the volume used is dependent on the degree of bacterial contamination on the hands Compact dry plates will be used for the detection of Ecoli and total coliforms
The lower detection limit of CFUs will be calculated by dividing 1 CFUplate by the filtrate volume and then multiplying it with the total Whirl-Pak volume of 350 mL The upper detection limit will be calculated by dividing 500 CFUsplate by the filtrate volume and then multiplying it with the Whirl-Pak volume For the statistical analysis the CFUs per hand will be normalized and and log10 transformed
Module 4 Diary approach for pre-defined health outcomes Longitudinal data on hygiene-related health outcomes of patients and disease-related absences of HCWs will be collected during 9 months after the intervention in both of the study arms from the cluster-randomized controlled trial with a diary approach Every time a pre-defined health outcome takes place at facility level this outcome will be reported in a diary by the director of the PHCF or someone who was appointed by the director No patient names or birth dates will be recorded to keep this data fully anonymous For each health outcome the director will report when it happened if applicable how long it took if applicable the number of days of treatment if known the reason for the outcome and if it was an infection the outcome recovered death unknown These health outcomes either occur directly at the health care facility if the facility offers inpatient care or are reported if the patients report their outcome after a visit eg by calling or re-visiting the facility The diary consists of one table per month containing all of the different health outcomes and subcategories Consequently the HCWs can keep track of these outcomes with a minimal administrative effort The local study team is still discussing if a paper table which will be collected once a month will be used or if alternatively the team sends the doctor in charge once a month a mobile survey to fill in the data
Module 5 Focus Group Discussions The FGDs will be used to capture the common norms and beliefs of the HCWs This tool offers many insights in shorter time compared to other qualitative methods such as participatory observation Data will be collected by a small local team with experience in qualitative data collection and if the security situation allows by the Swiss TPH PhD student in autumn 2023 The team containing at least one moderator and one observernote taker will be trained by the PhD student prior to data collection A field research journal will be used throughout the study to take structured notes and observations of the FGDs The discussions will be audio recorded and then transcribed into the local language and translated to French or English for further analysis
Field notes observation notes and focus group transcripts will be analysed using the framework method with the software MaxQDA VERBI Software Marburg Germany or NVivo QSR International Melbourne Australia
Module 6 Key informant interviews The KIIs will engage with other stakeholders outside of the health care facilities who have an influence on the intervention areas of the project Some of these key informants will have been identified through the Theory of Change analysis while others will be suggested by local partners Individual interviewees were chosen as a tool to gain the insights of these stakeholders such as people from the ministry of health or the mayor so that their status does not influence other participants freedom of speech The KIIs can be additionally used to inquire further about questions or topics which came up during the FGDs Further the format of interviewing can also be used on the health care facility level in case not enough participants are available for a FGD The KIIs will take place in autumn 2023
Interviewers will receive the same training as for the Focus Group Discussions The interviews will be audio recorded and then transcribed into the local language and translated to French or English for further analysis In some instances interviews may be carried out remotely online from Switzerland in French if it is appropriate They will be audio recorded transcribed and translated if necessary for further analysis
As the FGD transcripts the interviews will be analysed using the framework method with the software MaxQDA VERBI Software Marburg Germany or NVivo QSR International Melbourne Australia
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 workers understanding of hygiene and expected positive and negative impacts of the intervention with Graviteau 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 studys 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
Module 1 Combined RANAS and KAP survey The survey will be developed through the RANAS approach and will not only include attitude and belief questions but also target the underlying psychological factors postulated by the RANAS model that are important precursors for effective behaviour change If needed this survey will be enriched with additional questions to assess knowledge and self-reported handwashing practices of the participants The survey will be administered to HCWs three times in total as a baseline survey before the intervention package about two months after the intervention and about a year after the baseline survey with the software Open Data Kit ODK Central version 202231 on Android tablets
Module 2 Structured handwashing observations Structured handwashing observations are perceived as a gold standard method to assess handwashing behaviour Data from Module 1 and the observations can later be combined through a unique ID of the study participants The observations will be administered with HCWs three times at the same time points as the survey in Module 1
A trained observer from a Tdh team or the local ministry of health who normally works in the health care facilities with a different function will visit the facility under the pretence of their usual function They will be equipped with an observation tool and will follow a healthcare worker for a minimum of one hour at the peak time per PHCF unit for patient visits The observer will not declare that heshe is observing handwashing practices Consent will be obtained at a health care facility level from the director of the health care facility To avoid making patients feel uncomfortable during sensitive procedures such as giving birth only patient visits containing physical examination injection and blood sampling will be observed and the patients will be asked for their oral consent prior to entering a room with them
Module 3 Microbiological analysis of hand rinse samples Hand rinse samples of HCWs will be collected after the survey with a modified glove juice method as described by Pickering et al 2010 For the hand rinse sample collection the participants hand will be inserted into a 69-oz Whirl-Pak bag NASCO Corp Fort Atkinson WI filled with 350 mL of clean water Then the participant has to shake herhis hand in the water and rub herhis thumb and fingers together for 15 seconds Afterwards the data collector will massage the participants hand through the bag for another 15 seconds The participant will be provided with a paper towel to dry the hand once it is retrieved from the bag Afterwards the procedure will be repeated with the other hand
The Whirl-Pak bags containing the samples will be kept on ice in an isolation box and processed within 4 hours of sampling Membrane filtration will be used to detect colony-forming units CFUs of EColi and total coliforms In a field laboratory the content of the bags will be passed through a 47-mm-diameter 045 µm cellulose filter The filter paper will then be placed on growth media and incubated at 35C 05C for a duration of 24 hours for EColi and total coliforms 45 We plan to filter 100 mL per bag to detect CFUs of EColi and total coliforms The exact amount of mL will be established during piloting as the volume used is dependent on the degree of bacterial contamination on the hands Compact dry plates will be used for the detection of Ecoli and total coliforms
The lower detection limit of CFUs will be calculated by dividing 1 CFUplate by the filtrate volume and then multiplying it with the total Whirl-Pak volume of 350 mL The upper detection limit will be calculated by dividing 500 CFUsplate by the filtrate volume and then multiplying it with the Whirl-Pak volume For the statistical analysis the CFUs per hand will be normalized and and log10 transformed
Module 4 Diary approach for pre-defined health outcomes Longitudinal data on hygiene-related health outcomes of patients and disease-related absences of HCWs will be collected during 9 months after the intervention in both of the study arms from the cluster-randomized controlled trial with a diary approach Every time a pre-defined health outcome takes place at facility level this outcome will be reported in a diary by the director of the PHCF or someone who was appointed by the director No patient names or birth dates will be recorded to keep this data fully anonymous For each health outcome the director will report when it happened if applicable how long it took if applicable the number of days of treatment if known the reason for the outcome and if it was an infection the outcome recovered death unknown These health outcomes either occur directly at the health care facility if the facility offers inpatient care or are reported if the patients report their outcome after a visit eg by calling or re-visiting the facility The diary consists of one table per month containing all of the different health outcomes and subcategories Consequently the HCWs can keep track of these outcomes with a minimal administrative effort The local study team is still discussing if a paper table which will be collected once a month will be used or if alternatively the team sends the doctor in charge once a month a mobile survey to fill in the data
Module 5 Focus Group Discussions The FGDs will be used to capture the common norms and beliefs of the HCWs This tool offers many insights in shorter time compared to other qualitative methods such as participatory observation Data will be collected by a small local team with experience in qualitative data collection and if the security situation allows by the Swiss TPH PhD student in autumn 2023 The team containing at least one moderator and one observernote taker will be trained by the PhD student prior to data collection A field research journal will be used throughout the study to take structured notes and observations of the FGDs The discussions will be audio recorded and then transcribed into the local language and translated to French or English for further analysis
Field notes observation notes and focus group transcripts will be analysed using the framework method with the software MaxQDA VERBI Software Marburg Germany or NVivo QSR International Melbourne Australia
Module 6 Key informant interviews The KIIs will engage with other stakeholders outside of the health care facilities who have an influence on the intervention areas of the project Some of these key informants will have been identified through the Theory of Change analysis while others will be suggested by local partners Individual interviewees were chosen as a tool to gain the insights of these stakeholders such as people from the ministry of health or the mayor so that their status does not influence other participants freedom of speech The KIIs can be additionally used to inquire further about questions or topics which came up during the FGDs Further the format of interviewing can also be used on the health care facility level in case not enough participants are available for a FGD The KIIs will take place in autumn 2023
Interviewers will receive the same training as for the Focus Group Discussions The interviews will be audio recorded and then transcribed into the local language and translated to French or English for further analysis In some instances interviews may be carried out remotely online from Switzerland in French if it is appropriate They will be audio recorded transcribed and translated if necessary for further analysis
As the FGD transcripts the interviews will be analysed using the framework method with the software MaxQDA VERBI Software Marburg Germany or NVivo QSR International Melbourne Australia
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