Hand, Foot and Mouth DiseaseNCT07839442
CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
A study testing HFMD-PREP (HFMD Prevention and Response Enhancement Programme) in people with Hand, Foot and Mouth Disease and Infection Control, run by Helmy Sajali, MD, MPH at 1 site in Malaysia.
Trial summary
Hand, foot and mouth disease (HFMD) is endemic in Malaysia and disproportionately affects children in childcare settings, where institutional infection prevention and control (IPC) capacity is frequently inadequate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease, Infection Control
- What is being tested?
- HFMD-PREP (HFMD Prevention and Response Enhancement Programme)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Registered/licensed childcare or ECEC centre
- Operational for 2 years or more
- 10 or more children enrolled
- Located within Kota Kinabalu district
Who cannot join
- Planned closure or relocation during the study period
- Concurrent participation in another infection-prevention intervention
- Home-based centre with fewer than 10 children enrolled
- Inclusion Criteria (individual level - staff and parents/guardians):
- Employed as childcare staff at, or parent/guardian of a child enrolled at, a participating centre
- Willing and able to provide informed consent
Show all 9Show fewer
- Unable to provide informed consent
- Children are not individually enrolled at any stage; no child is approached, examined, interviewed, or identified as part of this study.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah
Kota Kinabalu, Sabah
Helmy Sajali @ Majali, +601129857445, amiesajali@gmail.com
About this study
Official title: Development and Evaluation of CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu: A Stepped-Wedge Cluster Randomised Trial
Hand, foot and mouth disease (HFMD) is endemic in Malaysia and disproportionately affects children in childcare settings, where institutional infection prevention and control (IPC) capacity is frequently inadequate. This study develops and evaluates two linked tools: CHIPCAT (Childcare Infection Prevention Capacity Assessment Tool), which generates the Infection Prevention Capacity Index (IPCI) as an institutional capacity score, and HFMD-PREP (HFMD Prevention and Response Enhancement Programme), a structured capacity-building intervention mapped to CHIPCAT domains. Following instrument development and validation, the intervention is evaluated using a stepped-wedge cluster randomised trial (SW-CRT) across 12 licensed childcare centres in Kota Kinabalu, Sabah, Malaysia. All centres receive HFMD-PREP by the end of the study; only the timing of crossover differs by randomised sequence. The primary outcome is the change in IPCI. Secondary outcomes are staff and parent knowledge, attitude and practice (KAP) scores. HFMD incidence is analysed as an exploratory secondary disease outcome. This study is also registered with the Malaysian National Medical Research Register (NMRR ID RSCH ID-26-05258-LQ3), with parallel ethics submission to the Ministry of Health Malaysia Medical Research Ethics Committee (MOH MREC).
- Conditions
- Hand, Foot and Mouth Disease, Infection Control
- Being tested
- HFMD-PREP (HFMD Prevention and Response Enhancement Programme)
- Keywords
- HFMD, childcare centres, stepped-wedge cluster randomised trial, Malaysia
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFMD-PREP (HFMD Prevention and Response Enhancement Programme)Behavioural
A structured, six-component digital capacity-building intervention mapped to the six CHIPCAT domains (governance and policies; human resources and training; service delivery practices; supplies and physical environment; communication and engagement; sustainability and system integration), delivered through Track A (childcare providers) and Track B (parents/guardians) via the hfmdprep.my platform.
| Study group | Role | What they receive |
|---|---|---|
| Control period (usual practice) | No intervention | Period during which a centre has not yet crossed over to HFMD-PREP. Centres continue existing HFMD prevention routines, including any standard MOH-recommended practices already in place; no centre is asked to discontinue existing prevention activities. |
| HFMD-PREP intervention period | Experimental | Period following a centre's randomised crossover step, during which the centre receives HFMD-PREP (HFMD Prevention and Response Enhancement Programme), a structured six-component digital capacity-building intervention delivered to childcare providers (Track A) and parents/guardians (Track B) via the hfmdprep.my platform, mapped to the six CHIPCAT domains. Receives: Behavioral: HFMD-PREP (HFMD Prevention and Response Enhancement Programme) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Prevention Capacity Index (IPCI)
Centre-level composite score generated by CHIPCAT (Childcare Infection Prevention Capacity Assessment Tool), calculated as the sum of item scores divided by the total maximum possible score, multiplied by 100 (range 0-100, higher scores indicate greater institutional infection prevention and control capacity). Analysed using a linear mixed-effects model with fixed effects for intervention status and time period and a random intercept for centre.
Measured: Baseline (Week 0) and Weeks 4, 8, 12, and 16
Secondary outcomes (3)
Staff Knowledge, Attitude and Practice (KAP) score
Composite and subscale (knowledge, attitude, practice) scores from the Staff HFMD KAP questionnaire (Hamirudin et al., 2021), expressed as a percentage of subscale maximum. Analysed by linear mixed-effects model with random intercepts for individual nested within centre.
Measured: Baseline (Week 0) and Weeks 4, 8, 12, and 16
Parent/Guardian Knowledge, Attitude and Practice (KAP) score
Composite and subscale (knowledge, attitude, practice) scores from the Parent/Guardian HFMD KAP questionnaire (Abd Ghani \& Mansor, 2024), expressed as a percentage of subscale maximum. Analysed by linear mixed-effects model with random intercepts for individual nested within centre.
Measured: Baseline (Week 0) and Weeks 4, 8, 12, and 16
HFMD incidence (exploratory secondary outcome)
Aggregated, centre-level HFMD case counts expressed as cases per 100 child-months, extracted from routine centre records. No individual child is enrolled or identified. AnalysWeeks 0 through 16 (aggregated across the 5 measurement periods)ed using Poisson or negative binomial models as an exploratory secondary disease outcome; the trial is not powered on this endpoint.
Measured: Weeks 0 through 16 (aggregated across the 5 measurement periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies 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
- Stepped-wedge cluster randomised trial. Twelve childcare centres (clusters), stratified by age group served and documented HFMD outbreak history, are randomised to one of four sequential crossover steps (three centres per step) across five measurement periods (one baseline plus four follow-up periods, approximately every four weeks). All centres begin in the control condition (usual HFMD prevention practice) and cross over to the HFMD-PREP intervention at their assigned step; all centres receive the intervention by the end of the trial and no centre remains permanently in the control condition.
- Masking
- None (open label)
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helmy Sajali, MD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helmy Sajali, MD, MPH, Universiti Malaysia Sabah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839442
- Sponsor's protocol ID
- CHIPCAT-HFMDPREPv.05.07.2026
- Other IDs
- NMRR ID-26-03135-GPA
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu: A Stepped-Wedge Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT07839442
- Acronym / sponsor ID
- CHIPCAT-HFMDPREPv.05.07.2026
- Conditions
- Hand, Foot and Mouth Disease, Infection Control
- Keywords
- HFMD, childcare centres, stepped-wedge cluster randomised trial, Malaysia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Helmy Sajali, MD, MPHUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Sep 2026 (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.
Hand, foot and mouth disease (HFMD) is endemic in Malaysia and disproportionately affects children in childcare settings, where institutional infection prevention and control (IPC) capacity is frequently inadequate. This study develops and evaluates two linked tools: CHIPCAT (Childcare Infection Prevention Capacity Assessment Tool), which generates the Infection Prevention Capacity Index (IPCI) as an institutional capacity score, and HFMD-PREP (HFMD Prevention and Response Enhancement Programme), a structured capacity-building intervention mapped to CHIPCAT domains. Following instrument development and validation, the intervention is evaluated using a stepped-wedge cluster randomised trial (SW-CRT) across 12 licensed childcare centres in Kota Kinabalu, Sabah, Malaysia. All centres receive HFMD-PREP by the end of the study; only the timing of crossover differs by randomised sequence. The primary outcome is the change in IPCI. Secondary outcomes are staff and parent knowledge, attitude and practice (KAP) scores. HFMD incidence is analysed as an exploratory secondary disease outcome. This study is also registered with the Malaysian National Medical Research Register (NMRR ID RSCH ID-26-05258-LQ3), with parallel ethics submission to the Ministry of Health Malaysia Medical Research Ethics Committee (MOH MREC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomised trial. Twelve childcare centres (clusters), stratified by age group served and documented HFMD outbreak history, are randomised to one of four sequential crossover steps (three centres per step) across five measurement periods (one baseline plus four follow-up periods, approximately every four weeks). All centres begin in the control condition (usual HFMD prevention practice) and cross over to the HFMD-PREP intervention at their assigned step; all centres receive the intervention by the end of the trial and no centre remains permanently in the control condition.
| Arm | Type | Receives |
|---|---|---|
| Control period (usual practice) | No intervention | –Period during which a centre has not yet crossed over to HFMD-PREP. Centres continue existing HFMD prevention routines, including any standard MOH-recommended practices already in place; no centre is asked to discontinue existing prevention activities. |
| HFMD-PREP intervention period | Experimental | Behavioral: HFMD-PREP (HFMD Prevention and Response Enhancement Programme)Period following a centre's randomised crossover step, during which the centre receives HFMD-PREP (HFMD Prevention and Response Enhancement Programme), a structured six-component digital capacity-building intervention delivered to childcare providers (Track A) and parents/guardians (Track B) via the hfmdprep.my platform, mapped to the six CHIPCAT domains. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Registered/licensed childcare or ECEC centre
- Operational for 2 years or more
- 10 or more children enrolled
- Located within Kota Kinabalu district
Key exclusion criteria (9 listed)
- Planned closure or relocation during the study period
- Concurrent participation in another infection-prevention intervention
- Home-based centre with fewer than 10 children enrolled
- Employed as childcare staff at, or parent/guardian of a child enrolled at, a participating centre
- Willing and able to provide informed consent
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 |
|---|---|---|
| HFMD-PREP (HFMD Prevention and Response Enhancement Programme)A structured, six-component digital capacity-building intervention mapped to the six CHIPCAT domains (governance and policies; human resources and training; service delivery practices; supplies and physical environment; communication and engagement; sustainability and system integration), delivered through Track A (childcare providers) and Track B (parents/guardians) via the hfmdprep.my platform. | Behavioural | HFMD-PREP intervention period |
Primary outcome
Infection Prevention Capacity Index (IPCI)
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, and 16
Centre-level composite score generated by CHIPCAT (Childcare Infection Prevention Capacity Assessment Tool), calculated as the sum of item scores divided by the total maximum possible score, multiplied by 100 (range 0-100, higher scores indicate greater institutional infection prevention and control capacity). Analysed using a linear mixed-effects model with fixed effects for intervention status and time period and a random intercept for centre.
3 secondary outcomes
Staff Knowledge, Attitude and Practice (KAP) score
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, and 16
Parent/Guardian Knowledge, Attitude and Practice (KAP) score
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, and 16
HFMD incidence (exploratory secondary outcome)
Time frame: Weeks 0 through 16 (aggregated across the 5 measurement periods)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFMD-PREP (HFMD Prevention and Response Enhancement Programme) in people with Hand, Foot and Mouth Disease and Infection Control, run by Helmy Sajali, MD, MPH at 1 site in Malaysia.
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 9 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: opening soon, as of the sponsor's last update on 13 Oct 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helmy Sajali @ Majali (+601129857445, amiesajali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection Prevention Capacity Index (IPCI) (time frame: Baseline (Week 0) and Weeks 4, 8, 12, and 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.