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

October 9, 2026 updated by: Helmy Sajali, MD, MPH

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

780

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia
        • Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control period (usual practice)

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.
Experimental: HFMD-PREP intervention period

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 0) and Weeks 4, 8, 12, and 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

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.
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)

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.
Weeks 0 through 16 (aggregated across the 5 measurement periods)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helmy Sajali, MD, MPH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 18, 2026

First Posted (Actual)

September 24, 2026

Study Record Updates

Last Update Posted (Actual)

October 13, 2026

Last Update Submitted That Met QC Criteria

October 9, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIPCAT-HFMDPREPv.05.07.2026
  • NMRR ID-26-03135-GPA (Registry Identifier: National Medical Research Register (NMRR), Malaysia)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe