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CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu

ConditionsHand, Foot and Mouth DiseaseInfection Control
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelmy Sajali, MD, MPH

About this 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Registered/licensed childcare or ECEC centre

Operational for 2 years or more

10 or more children enrolled

Located within Kota Kinabalu district

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • HFMD-PREP (HFMD Prevention and Response Enhancement Programme)

    Behavioral

    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.

Treatment groups

780 Participants
are divided into 2 treatment groups
Group A: Control period (usual practice)No intervention 0 interventions
Group B: HFMD-PREP intervention periodExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helmy Sajali, MD, MPH

Lead sponsor

Universiti Malaysia Sabah

Sponsor institution

Source ClinicalTrials.gov

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