Hospital-acquired InfectionsIPC-HAINCT05547373
Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections
A study of Hospital-acquired Infections, run by National University of Singapore at 1 site in Cambodia.
Trial summary
Hospital-acquired infections (HAIs) are significant public health issues, especially in low- and middle-income countries (LMICs). Hand hygiene and low-level disinfection of equipment (LLDE) practices among healthcare workers (HCWs) are essential to reduce HAIs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hospital-acquired Infections
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Apr 2023to 30 Jun 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare workers working in the selected wards and of chosen hospitals
- Aged 18 years or above
- Working in the selected wards of the chosen hospitals for at least six months
- Being able and agreeing to provide informed consent to participate in the study
Who cannot join
- Interns and visiting healthcare workers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Piloting an Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections in Cambodia and Lao PDR
Hospital-acquired infections (HAIs) are significant public health issues, especially in low- and middle-income countries (LMICs). Hand hygiene and low-level disinfection of equipment (LLDE) practices among healthcare workers (HCWs) are essential to reduce HAIs. Various effective infection prevention and control (IPC) interventions to reduce HAI incidence have been developed. However, which interventions work effectively in LMICs has not been identified. The investigators aim to develop, pilot, and assess the feasibility and acceptability of an IPC intervention in Cambodia and the Lao People's Democratic Republic (PDR).
Read the detailed description
This study consists of four phases guided by the Medical Research Council (MRC) framework. Three hospitals from each country will be selected. In Phase 1, the investigators will conduct a gap analysis of IPC implementation and practices among HCWs at each hospital through desk review, direct observation of hand hygiene and LLDE practices, in-depth interviews with HCWs, and key informant interviews with stakeholders. In Phase 2, the investigators will develop an IPC intervention based on results from Phase 1 and interventions selected from the literature review of IPC interventions in LMICs. In Phase 3, the investigators will pilot the developed intervention in the same hospitals selected in Phase 1. Finally, in Phase 4, the investigators will assess the feasibility and acceptability of the developed intervention among HCWs and stakeholders at the selected hospitals. The investigators will employ the MRC framework to develop and evaluate an intervention to reduce HAIs in both countries. The investigators will also use a theoretical framework to explore factors that are barriers and enablers for HCWs to improve hand hygiene compliance. With these approaches, the investigators will be able to develop a comprehensive intervention. Findings from this study would shed light on promising IPC interventions to reduce HAI incidence in Cambodia and Lao PDR. More importantly, the findings may be applied to other LMIC settings.
- Conditions
- Hospital-acquired Infections
- Being tested
- Infection prevention and control (IPC)
- Keywords
- Infection control, Prevention, Hand hygiene, Healthcare workers, Low- and middle-income countries, Asia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infection prevention and control (IPC)Behavioural
The intervention will be developed by matching behavioral change components identified in the gap analysis stage with the intervention components extracted from a systematic review. The investigators will use the Behavior Change Wheel (BCW) model as a guide to design this infection control prevention and control intervention. In brief, the intervention development processes will follow eight steps based on the BCW. The steps will include defining the problem in behavioral terms, selecting the target behaviors, specifying the target behaviors, identifying what needs to change, identifying intervention functions, identifying policy categories, identifying behavior change techniques, and identifying the mode of delivery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The investigators will select HCWs from the selected departments at the national hospitals, provincial hospitals, and district referral hospitals to participate in the pilot intervention. The participants will also include representatives from the Communicable Disease Control Department and the Department of Hospital Services of the Ministry of Health, the provincial hospitals, and the district referral hospitals in Cambodia and Lao PDR. Receives: Behavioral: Infection prevention and control (IPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hand hygiene compliance among health workers from baseline to endline
The investigators will calculate hand hygiene compliance by having the hand hygiene action of alcohol hand rub or hand washing using soap and water divided by the hand hygiene opportunity and multiple with 100.
Measured: At endline (6 months after the intervention started)
Secondary outcomes (1)
Perceived feasibility and acceptability of the infection prevention and control intervention among HCWs and stakeholders
The investigators will conduct a post-intervention qualitative evaluation to assess the feasibility and acceptability and identify challenges in implementing the infection prevention and control intervention following the Medical Research Council's framework.
Measured: At endline (6 months after the intervention started)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Apr 2023
- Primary completion31 Dec 2025
- Study completion30 Jun 2026
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-acquired InfectionsStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Siyan Yi, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547373
- Sponsor's protocol ID
- RCP100737ITDC
- Acronym
- IPC-HAI
- Status last verified
- Nov 2023
- First submitted
- 13 Sep 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oy S, Saing CH, Ung M, Zahari M, Nouhak I, Kim S, Nagashima-Hayashi M, Khuon D, Koy V, Mam S, Sayasone S, Saphonn V, Yi S. Developing an infection prevention and control intervention to reduce hospital-acquired infections in Cambodia and Lao People's Democratic Republic: the HAI-PC study protocol. Front Public Health. 2023 Sep 20;11:1239228. doi: 10.3389/fpubh.2023.1239228. eCollection 2023.
PubMed 37799162
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Piloting an Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections in Cambodia and Lao PDR
- ClinicalTrials.gov ID
- NCT05547373
- Acronym / sponsor ID
- IPC-HAI / RCP100737ITDC
- Conditions
- Hospital-acquired Infections
- Keywords
- Infection control, Prevention, Hand hygiene, Healthcare workers, Low- and middle-income countries, Asia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 21 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.
Hospital-acquired infections (HAIs) are significant public health issues, especially in low- and middle-income countries (LMICs). Hand hygiene and low-level disinfection of equipment (LLDE) practices among healthcare workers (HCWs) are essential to reduce HAIs. Various effective infection prevention and control (IPC) interventions to reduce HAI incidence have been developed. However, which interventions work effectively in LMICs has not been identified. The investigators aim to develop, pilot, and assess the feasibility and acceptability of an IPC intervention in Cambodia and the Lao People's Democratic Republic (PDR).
Detailed description
This study consists of four phases guided by the Medical Research Council (MRC) framework. Three hospitals from each country will be selected. In Phase 1, the investigators will conduct a gap analysis of IPC implementation and practices among HCWs at each hospital through desk review, direct observation of hand hygiene and LLDE practices, in-depth interviews with HCWs, and key informant interviews with stakeholders. In Phase 2, the investigators will develop an IPC intervention based on results from Phase 1 and interventions selected from the literature review of IPC interventions in LMICs. In Phase 3, the investigators will pilot the developed intervention in the same hospitals selected in Phase 1. Finally, in Phase 4, the investigators will assess the feasibility and acceptability of the developed intervention among HCWs and stakeholders at the selected hospitals. The investigators will employ the MRC framework to develop and evaluate an intervention to reduce HAIs in both countries. The investigators will also use a theoretical framework to explore factors that are barriers and enablers for HCWs to improve hand hygiene compliance. With these approaches, the investigators will be able to develop a comprehensive intervention. Findings from this study would shed light on promising IPC interventions to reduce HAI incidence in Cambodia and Lao PDR. More importantly, the findings may be applied to other LMIC settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Infection prevention and control (IPC)The investigators will select HCWs from the selected departments at the national hospitals, provincial hospitals, and district referral hospitals to participate in the pilot intervention. The participants will also include representatives from the Communicable Disease Control Department and the Department of Hospital Services of the Ministry of Health, the provincial hospitals, and the district referral hospitals in Cambodia and Lao PDR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthcare workers working in the selected wards and of chosen hospitals
- Aged 18 years or above
- Working in the selected wards of the chosen hospitals for at least six months
- Being able and agreeing to provide informed consent to participate in the study
Key exclusion criteria (1 listed)
- Interns and visiting healthcare workers
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 |
|---|---|---|
| Infection prevention and control (IPC)The intervention will be developed by matching behavioral change components identified in the gap analysis stage with the intervention components extracted from a systematic review. The investigators will use the Behavior Change Wheel (BCW) model as a guide to design this infection control prevention and control intervention. In brief, the intervention development processes will follow eight steps based on the BCW. The steps will include defining the problem in behavioral terms, selecting the target behaviors, specifying the target behaviors, identifying what needs to change, identifying intervention functions, identifying policy categories, identifying behavior change techniques, and identifying the mode of delivery. | Behavioural | Intervention |
Primary outcome
Changes in hand hygiene compliance among health workers from baseline to endline
Time frame: At endline (6 months after the intervention started)
The investigators will calculate hand hygiene compliance by having the hand hygiene action of alcohol hand rub or hand washing using soap and water divided by the hand hygiene opportunity and multiple with 100.
1 secondary outcome
Perceived feasibility and acceptability of the infection prevention and control intervention among HCWs and stakeholders
Time frame: At endline (6 months after the intervention started)
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 16 Sep 2026.
- Derived from this study: PubMed 37799162Oy S, Saing CH, Ung M, Zahari M, Nouhak I, Kim S, Nagashima-Hayashi M, Khuon D, Koy V, Mam S, Sayasone S, Saphonn V, Yi S. Developing an infection prevention and control intervention to reduce hospital-acquired infections in Cambodia and Lao People's Democratic Republic: the HAI-PC study protocol. Front Public Health. 2023 Sep 20;11:1239228. doi: 10.3389/fpubh.2023.1239228. eCollection 2023.
- 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 of Hospital-acquired Infections, run by National University of Singapore 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 4 inclusion and 1 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 16 Sep 2026. 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?
Changes in hand hygiene compliance among health workers from baseline to endline (time frame: At endline (6 months after the intervention started)). 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 NCT05547373, 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 16 Sep 2026.