An interventional study of HFMD-PREP (HFMD Prevention and Response Enhancement Programme) in Hand, Foot and Mouth Disease and Infection Control, sponsored by Helmy Sajali, MD, MPH. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Helmy Sajali, MD, MPH · Not applicable, Interventional, and Prevention
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).
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 10 are open to participants now.
This study's planned enrollment of 780 is above the median of 467 across 50 interventional studies indexed under Hand, Foot and Mouth Disease.
Browse Hand, Foot and Mouth Disease studies →This is the only study on the registry with Helmy Sajali, MD, MPH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria (centre level):
Exclusion Criteria (centre level):
Inclusion Criteria (individual level - staff and parents/guardians):
Exclusion Criteria (individual level):
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Behavioral: 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.
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.
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, and 16
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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 0 through 16 (aggregated across the 5 measurement periods)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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