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

NCT07839442 | Not Yet Recruiting

• 2 other identifiers: CHIPCAT-HFMDPREPv.05.07.2026RSCH ID-26-05258-LQ3
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

HFMD; childcare centres; stepped-wedge cluster randomised trial; Malaysia

Outcome Measures

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.

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

Secondary Outcomes (3)

• Staff Knowledge, Attitude and Practice (KAP) score

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

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

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

• HFMD incidence (exploratory secondary outcome)

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

Study Arms (2)

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.

Behavioral: HFMD-PREP (HFMD Prevention and Response Enhancement Programme)

Interventions

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.

HFMD-PREP intervention period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Helmy Sajali, MD, MPH: lead

Study Sites (1)

Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah

Kota Kinabalu, Sabah, Malaysia

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Helmy Sajali @ Majali

CONTACT

+601129857445; amiesajali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the dual role of the principal investigator as both CHIPCAT assessor and HFMD-PREP deliverer, no formal masking is applied. Observation bias in CHIPCAT/IPCI scoring is mitigated through standardised scoring protocols and independent verification of 20% of assessments by a Health Officer not otherwise involved in intervention delivery.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DrPH Candidate

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

MY (1)