Hospital InfectionsNCT05540886
CLEAN Frontline: A Stepped Wedge Cluster Trial
A study testing TEACH CLEAN in people with Hospital Infections and Environment, Controlled, run by London School of Hygiene and Tropical Medicine at 1 site in Cambodia.
Trial summary
Environmental hygiene is a key component of infection prevention in healthcare, and a driver of healthcare associated infections. Staff who clean in many low resource countries receive no formal training on cleaning, waste disposal and linen handling. This issue has been execrated by the COVID-19 pandemic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hospital Infections, Environment, Controlled, Infection Control
- What is being tested?
- TEACH CLEAN
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Mar 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Surfaces outside the patient zone
- Surfaces not in the wards of interest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLEAN FRONTLINE CAMBODIA A Stepped Wedge Cluster Trial of an Environmental Hygiene Educational Intervention Across Thirteen Cambodian Hospitals
Environmental hygiene is a key component of infection prevention in healthcare, and a driver of healthcare associated infections. Staff who clean in many low resource countries receive no formal training on cleaning, waste disposal and linen handling. This issue has been execrated by the COVID-19 pandemic. The only recommended training on environmental hygiene for low resourced facilities, TEACH CLEAN, uses a training of trainers model. A selected cadre "champions" which in turn train their peers with responsibilities on environmental hygiene at the facility level. Early pilot data to test its effectiveness of this training package are very promising.
The main objective is to evaluate the effectiveness of an environmental cleaning bundle to improve microbiological cleanliness in Cambodian hospitals.
Read more
The latest TEACH CLEAN will be implemented across all hospitals (13) of three provinces in Cambodia. A stepped wedge randomised trial will be used to evaluate the effectiveness of TEACH CLEAN to improve microbiological cleanliness in Cambodian hospitals. All facilities will receive the intervention. Hospitals are arranged in groups of three or four based on the randomisation with staggered commencement dates of the intervention at four distinct time points. The design will include ten months of data collection. We expect one month gap between the training of champions and the training of staff at the facility level. The main outcome is microbiological cleanliness (<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) measured using a non-specific agar on one side for measuring total Aerobic Colony Counts (ACC/cm2). With 30 sampling sites in each hospital and with a pre-training cleanliness proportion ranging from 30% to 50% will give us over 85% power to detect a 10% absolute post-intervention increase in cleanliness.
Evidence from this trial will contribute to future policy and practice guidelines about hospital environmental hygiene and ultimately reduce healthcare associated infections. This would be the first randomised trial on environmental hygiene in low resource settings.
- Being tested
- TEACH CLEAN
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACH CLEANBehavioural
The intervention is primary a training facility cleaning champions to educate and supervise other existing facility cleaners with environmental hygiene responsibilities - training of trainers (ToT).
The training content includes as much as possible the seven contextualized modules of TEACH CLEAN training package (CLEAN BOX): i) Introduction to Infection Prevention and Control, ii) Personal hygiene and dress code, iii) Hand hygiene, iv) Personal protective equipment, v) Housekeeping/control of environment, vi) Waste handling, and vii) Linen handling.
Facility training will occur in three selected wards: i) maternity ward, including labour and post-natal rooms, ii) medicine ward, iii) and medicine ward.
There is also supervision stage that refers to ongoing mentorship of cleaning champions by the local partner while they educate and supervise existing facility cleaners with environmental hygiene responsibilities.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard practices are expected at hospitals before the education intervention is deployed |
| Intervention | Experimental | The main intervention - the training of trainers/champions (ToT) will be delivered to selected facility "cleaning champions" from three or four hospitals within a certain month. Four sets of ToT are expected to happen during the study period. Receives: Behavioral: TEACH CLEAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological cleanliness
The unit of measurement is high touch surfaces within the patient zone in each ward. Proportion of microbiological cleanliness (<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) will be calculated for each cluster as the number of sites with <2.5 cfu/cm2 out of the 30 sites sampled per period/month.
Measured: Data is collected monthly during the study period from each of the study sites. Because this is a stepped wedge trial with four steps, the data collection period referring to the pre-training/intervention period varies between 2 and 7 months. Whereas the
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a randomised cluster controlled trial using a stepped-wedge random allocation. At four distinct time points, 13 hospitals will receive the educational intervention. The unit of analysis is high frequency touches sites in the three wards of interest in each of the study hospitals.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Cambodia, WaterAid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540886
- Sponsor's protocol ID
- 26637
- Status last verified
- Feb 2022
- First submitted
- 1 Sep 2022
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gon G, Ma S, Aiken AM, Dancer SJ, Graham WJ, Nash S, Nov V, Mao S, Sarpong B, Pepper M, Vong S, Tang V, Thompson J, Por I. Impact of a multicomponent training intervention (Clean FrontLine) on microbiological cleanliness in Cambodian referral hospitals: a multicentre, stepped-wedge, cluster-randomised trial. Lancet Microbe. 2026 Feb;7(2):101262. doi: 10.1016/j.lanmic.2025.101262. Epub 2025 Dec 11.
PubMed 41389803
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEAN FRONTLINE CAMBODIA A Stepped Wedge Cluster Trial of an Environmental Hygiene Educational Intervention Across Thirteen Cambodian Hospitals
- ClinicalTrials.gov ID
- NCT05540886
- Acronym / sponsor ID
- 26637
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute of Public Health, Cambodia, WaterAid
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Environmental hygiene is a key component of infection prevention in healthcare, and a driver of healthcare associated infections. Staff who clean in many low resource countries receive no formal training on cleaning, waste disposal and linen handling. This issue has been execrated by the COVID-19 pandemic. The only recommended training on environmental hygiene for low resourced facilities, TEACH CLEAN, uses a training of trainers model. A selected cadre "champions" which in turn train their peers with responsibilities on environmental hygiene at the facility level. Early pilot data to test its effectiveness of this training package are very promising.
The main objective is to evaluate the effectiveness of an environmental cleaning bundle to improve microbiological cleanliness in Cambodian hospitals.
The latest TEACH CLEAN will be implemented across all hospitals (13) of three provinces in Cambodia. A stepped wedge randomised trial will be used to evaluate the effectiveness of TEACH CLEAN to improve microbiological cleanliness in Cambodian hospitals. All facilities will receive the intervention. Hospitals are arranged in groups of three or four based on the randomisation with staggered commencement dates of the intervention at four distinct time points. The design will include ten months of data collection. We expect one month gap between the training of champions and the training of staff at the facility level. The main outcome is microbiological cleanliness (<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) measured using a non-specific agar on one side for measuring total Aerobic Colony Counts (ACC/cm2). With 30 sampling sites in each hospital and with a pre-training cleanliness proportion ranging from 30% to 50% will give us over 85% power to detect a 10% absolute post-intervention increase in cleanliness.
Evidence from this trial will contribute to future policy and practice guidelines about hospital environmental hygiene and ultimately reduce healthcare associated infections. This would be the first randomised trial on environmental hygiene in low resource settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised cluster controlled trial using a stepped-wedge random allocation. At four distinct time points, 13 hospitals will receive the educational intervention. The unit of analysis is high frequency touches sites in the three wards of interest in each of the study hospitals.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard practices are expected at hospitals before the education intervention is deployed |
| Intervention | Experimental | Behavioral: TEACH CLEANThe main intervention - the training of trainers/champions (ToT) will be delivered to selected facility "cleaning champions" from three or four hospitals within a certain month. Four sets of ToT are expected to happen during the study period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Surfaces outside the patient zone
- Surfaces not in the wards of interest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEACH CLEANThe intervention is primary a training facility cleaning champions to educate and supervise other existing facility cleaners with environmental hygiene responsibilities - training of trainers (ToT). The training content includes as much as possible the seven contextualized modules of TEACH CLEAN training package (CLEAN BOX): i) Introduction to Infection Prevention and Control, ii) Personal hygiene and dress code, iii) Hand hygiene, iv) Personal protective equipment, v) Housekeeping/control of environment, vi) Waste handling, and vii) Linen handling. Facility training will occur in three selected wards: i) maternity ward, including labour and post-natal rooms, ii) medicine ward, iii) and medicine ward. There is also supervision stage that refers to ongoing mentorship of cleaning champions by the local partner while they educate and supervise existing facility cleaners with environmental hygiene responsibilities. | Behavioural | Intervention |
Primary outcome
Microbiological cleanliness
Time frame: Data is collected monthly during the study period from each of the study sites. Because this is a stepped wedge trial with four steps, the data collection period referring to the pre-training/intervention period varies between 2 and 7 months. Whereas the
The unit of measurement is high touch surfaces within the patient zone in each ward. Proportion of microbiological cleanliness (<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) will be calculated for each cluster as the number of sites with <2.5 cfu/cm2 out of the 30 sites sampled per period/month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 41389803Gon G, Ma S, Aiken AM, Dancer SJ, Graham WJ, Nash S, Nov V, Mao S, Sarpong B, Pepper M, Vong S, Tang V, Thompson J, Por I. Impact of a multicomponent training intervention (Clean FrontLine) on microbiological cleanliness in Cambodian referral hospitals: a multicentre, stepped-wedge, cluster-randomised trial. Lancet Microbe. 2026 Feb;7(2):101262. doi: 10.1016/j.lanmic.2025.101262. Epub 2025 Dec 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEACH CLEAN in people with Hospital Infections and Environment, Controlled, run by London School of Hygiene and Tropical Medicine at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological cleanliness (time frame: Data is collected monthly during the study period from each of the study sites. Because this is a stepped wedge trial with four steps, the data collection period referring to the pre-training/intervention period varies between 2 and 7 months. Whereas the). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05540886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.