The impact of wash text messages and environmental cues intervention on hand hygiene practice among healthcare workers in the greater Kampala metropolitan area, Uganda

ISRCTN	ISRCTN98148144
DOI	https://doi.org/10.1186/ISRCTN98148144
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	8-187
Sponsor	National Academy of Sciences
Funder	National Academy of Sciences

Submission date: 18/11/2020
Registration date: 23/11/2020
Last edited: 06/09/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Richard Mugambe
Scientific

New Mulago Hospital Complex
New Mulago Hill Road
Kampala
-
Uganda

ORCID ID	0000-0003-2311-5436
Phone	+256 789477677
Email	rmugambe@musph.ac.ug

Study information

Primary study design	Interventional
Study design	Cluster randomized trial
Secondary study design	Cluster randomised trial
Participant information sheet	ISRCTN98148144 _PIS.pdf
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
Study acronym	PEER MHEALTH STUDY
Study objectives	Mobile phone WASH text messages and environmental cues improve hand hygiene compliance among healthcare workers (HCWs)
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/09/2021

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	All
Target sample size at registration	450
Key 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
Key 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
Date of first enrolment	01/02/2021
Date of final enrolment	31/03/2021

Locations

Countries of recruitment

Uganda

Study participating centre

Makerere University School of Public Health

New Mulago Hospital Complex
P.o Box 7072
Kampala
-
Uganda

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		26/01/2021	29/11/2022	Yes	No
Other publications	Formative qualitative study	05/09/2024	06/09/2024	Yes	No
Participant information sheet			17/01/2024	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN98148144 _PIS.pdf: Participant information sheet

Editorial Notes

06/09/2024: Publication reference added.
19/01/2024: Patient information sheet added as an additional file.
29/11/2022: Publication reference added.
18/11/2020: Trial’s existence confirmed by Makere University