Plain English Summary
Background and study aims
Hand hygiene in healthcare facilities is very important in reducing the spread of hospital-acquired infections such as sepsis and COVID-19. Hand hygiene entails the use of soap and water or an alcohol-based hand rub to eliminate pathogens. The World Health Organization recommends that all healthcare workers need to wash their hands while in healthcare settings during critical moments such as before and after handling a patient, after touching a patient's surrounding, before and after any procedure. Compliance with these critical moments of hand hygiene is critical in averting hospital-acquired infections, however, this has not been the case in many healthcare settings in low-income settings, largely due to a lack of efficacious behavioral interventions. This interventional study will test the use of water, sanitation and hygiene (WASH) messages and nudges to improve hand hygiene among health workers in the greater Kampala metropolitan region.
Who can participate?
Full-time staff in the selected healthcare facilities, who have worked there for at least 6 months.
What does the study involve?
In this study, some health workers will receive simple hand hygiene facilities such as tapped plastic jerricans with a stand and basin while others will receive WASH text messages, nudges in addition to the simple hand washing facilities.
What are the possible benefits and risks of participating?
Health workers participating in this study will have an opportunity for their ideas being shared with policy makers and program implementers to influence and contribute to the promotion of hand hygiene practice in healthcare facilities. The risks involved by participating in this study are minimal. However, their views may become known to other people who have not participated in the interviews. We will minimize this by ensuring that only the individual directly responsible for this study will have access to the interviews. Only authorized project personnel (approved by the study Principal Investigator) will have access to this information.
Where is the study run from?
1. Makerere University School of Public Health, Kampala (Uganda)
2. Emory University (USA)
When is the study starting and how long is it expected to run for?
January 2020 to September 2021.
Who is funding the study?
National Academies of Science (USA)
Who is the main contact?
Dr Richard K. Mugambe, rmugambe@musph.ac.ug
Trial website
Contact information
Type
Scientific
Primary contact
Dr Richard Mugambe
ORCID ID
http://orcid.org/0000-0003-2311-5436
Contact details
New Mulago Hospital Complex
New Mulago Hill Road
Kampala
-
Uganda
+256 789477677
rmugambe@musph.ac.ug
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
8-187
Study information
Scientific title
The impact of a mhealth and environmental cues intervention on hand hygiene practice among healthcare workers in the greater Kampala metropolitan area. A cluster randomised trial
Acronym
PEER MHEALTH STUDY
Study hypothesis
Mobile phone WASH text messages and environmental cues improve hand hygiene compliance among healthcare workers (HCWs)
Ethics approval
Approved 15/04/2020, Makerere University School of Public Health Higher Degrees, Research and Ethics Committee (MakSPH-HDREC) (New Mulago Hospital Complex, New Mulago Hill Road, Kampala, Uganda; +256-393 291 397; hdrecadmin@musph.ac.ug), ref: Protocol 775
Study design
Cluster randomized trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Compliance with hand hygiene among healthcare workers
Intervention
In both the intervention and control HCFs, simple hand washing facilities (HWF) (tapped plastic jerricans with a stand and basin) will be provided (where needed) in delivery rooms, post-natal wards, and children’s ward. Soap for hand washing as well as alcohol hand rub will be provided at the hand hygiene stations. Hand hygiene demonstrations using the “glo germ” gel will be done in both study arms at the beginning of the study.
In the intervention HCFs, besides the provisions in the control group, two interventions, mhealth and environmental cues (nudges) will be provided. The choice of the specific mhealth and nudges intervention, and the frequency of exposure to mhealth messages among the study participants will be determined in the insight workshop. The mhealth intervention messages will be designed with a focus on: information on the benefits of hand hygiene; when to do hand hygiene; how to do hand hygiene and how to protect others. However, the messages will also have educational jokes and response prompts where HCWs with the highest number of responses will win hand hygiene supplies. The educational messages and jokes in the mhealth intervention will be guided by the results from the formative study. The mhealth messages will be sent to study participants using either short message service (sms) or whataspp, depending on the decision of the stakeholders in the stakeholders’ workshop.
Randomisation:
Selected healthcare facilities will be randomly assigned to the intervention and control arms. Randomization will be stratified at level III and IV HCF. All HCWs from the same HCF will be allocated to the same group as the randomized HCF in which they are working. HCWs will be masked off the intervention they are receiving.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Proportion of used Hand hygiene (HH) opportunities (number of times HH is observed to be done at critical times out of the total number of observed HH opportunities.
Hand hygiene observations will be conducted during the baseline, midline and end-line surveys. The hand hygiene observations will be done in the mornings (8 am – 12 pm) and evenings (4 pm – 8 pm) since these are considered to be peak treatment hours (Fries, Segre et al. 2012). Within the targeted time, 15 hand hygiene opportunities will be observed for each of the selected HCWs (corresponding to 3 patients each with 5 hand hygiene opportunities), and the used and missed opportunities will be recorded. Observations will be conducted by experienced researchers (HCWs or environmental health officers) who will observe from the least obtrusive point within a radius of 10 meters of the patient wards.
Secondary outcome measures
1. E. coli levels in hand rinsates from HCWs that indicate recent fecal contamination and HH failure collected immediately after the hand hygiene observations during baseline and end-line.
The samples (hand rinsates) will be collected by a team of trained environmental health officers. During sampling of hand rinsates, HCWs will put their hands, one at a time in Whirl-Pak bags containing distilled water. The HCWs will wash their hands by rubbing the inner hands for about 2 minutes and the enumerator massaging their hands from outside the whirl pak bag to remove any potential pathogens. Aseptic techniques will be used to collect duplicate samples from each of the study participants (HCWs) during baseline, midline and end-line. The samples will be stored in sterile plastic bottles and transported on ice to the laboratory for further analysis within 4 hours. Hand rinsates will be diluted using the ratios of 1:1, 1:10 and 1:100. The membrane filtration method (with Chromocult agar) will be used to concentrate samples, and incubation will be done at 37°C for 24 hours. Colonies of E.coli will be identified by their dark blue to violet colour, and they will be counted and recorded per 100ml of sample.
Overall trial start date
01/01/2020
Overall trial end date
30/09/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Full-time staff in the selected healthcare facility. This will be based on appointment letters wherever possible
2. Worked in the selected healthcare facility for at least 6 months prior to the study
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
A sample size of 30 clusters / HC IIIs and IVs (15 HCF under the intervention and 15 HCF under the control arm) with 15 HCWs per HCF
Participant exclusion criteria
1. All healthcare workers in maternal and children’s wards of selected healthcare, who will be on leave at the time of the baseline
2. All healthcare workers in maternal and children’s wards of selected healthcare, who will be so sick at the time of the baseline
Recruitment start date
01/02/2021
Recruitment end date
31/03/2021
Locations
Countries of recruitment
Uganda
Trial participating centre
Makerere University School of Public Health
New Mulago Hospital Complex
P.o Box 7072
Kampala
-
Uganda
Sponsor information
Organisation
National Academy of Sciences
Sponsor details
500 Fifth Street
NW
Washington
DC
20001
United States of America
+1(202) 334 3367
RGasior@nas.edu
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Academy of Sciences
Alternative name(s)
The National Academy of Sciences, US National Academy of Sciences, The NAS, NAS
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high impact journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
12/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list