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NCT Number: NCT07839442

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

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).

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Key information

Conditions

Hand, Foot and Mouth Disease Coxsackievirus Infections Enterovirus Infections Infection Control Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah

Kota Kinabalu, Sabah, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

(centre level):

  • Registered/licensed childcare or ECEC centre
  • Operational for 2 years or more
  • 10 or more children enrolled
  • Located within Kota Kinabalu district

Exclusion criteria

(centre level):

  • 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

Exclusion criteria

(individual level):

  • 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.

Exclusion criteria

-

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Staff Knowledge, Attitude and Practice (KAP) score

    Time frame: Baseline (Week 0) and Weeks 4, 8, 12, and 16

    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.

  2. Parent/Guardian Knowledge, Attitude and Practice (KAP) score

    Time frame: Baseline (Week 0) and Weeks 4, 8, 12, and 16

    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.

  3. HFMD incidence (exploratory secondary outcome)

    Time frame: Weeks 0 through 16 (aggregated across the 5 measurement periods)

    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.

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Sponsors and collaborators

Lead sponsor

Helmy Sajali, MD, MPH

Other

Registry information

Official study title

Development and Evaluation of CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu: A Stepped-Wedge Cluster Randomised Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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