NCT05547373

Brief Summary

Hospital-acquired infections (HAIs) are significant public health issues, especially in low- and middle-income countries (LMICs). Hand hygiene and low-level disinfection of equipment (LLDE) practices among healthcare workers (HCWs) are essential to reduce HAIs. Various effective infection prevention and control (IPC) interventions to reduce HAI incidence have been developed. However, which interventions work effectively in LMICs has not been identified. The investigators aim to develop, pilot, and assess the feasibility and acceptability of an IPC intervention in Cambodia and the Lao People's Democratic Republic (PDR).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

September 13, 2022

Last Update Submit

November 10, 2023

Conditions

Keywords

Infection controlPreventionHand hygieneHealthcare workersLow- and middle-income countriesAsia

Outcome Measures

Primary Outcomes (1)

  • Changes in hand hygiene compliance among health workers from baseline to endline

    The investigators will calculate hand hygiene compliance by having the hand hygiene action of alcohol hand rub or hand washing using soap and water divided by the hand hygiene opportunity and multiple with 100.

    At endline (6 months after the intervention started)

Secondary Outcomes (1)

  • Perceived feasibility and acceptability of the infection prevention and control intervention among HCWs and stakeholders

    At endline (6 months after the intervention started)

Study Arms (1)

Intervention

EXPERIMENTAL

The investigators will select HCWs from the selected departments at the national hospitals, provincial hospitals, and district referral hospitals to participate in the pilot intervention. The participants will also include representatives from the Communicable Disease Control Department and the Department of Hospital Services of the Ministry of Health, the provincial hospitals, and the district referral hospitals in Cambodia and Lao PDR.

Behavioral: Infection prevention and control (IPC)

Interventions

The intervention will be developed by matching behavioral change components identified in the gap analysis stage with the intervention components extracted from a systematic review. The investigators will use the Behavior Change Wheel (BCW) model as a guide to design this infection control prevention and control intervention. In brief, the intervention development processes will follow eight steps based on the BCW. The steps will include defining the problem in behavioral terms, selecting the target behaviors, specifying the target behaviors, identifying what needs to change, identifying intervention functions, identifying policy categories, identifying behavior change techniques, and identifying the mode of delivery.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare workers working in the selected wards and of chosen hospitals
  • Aged 18 years or above
  • Working in the selected wards of the chosen hospitals for at least six months
  • Being able and agreeing to provide informed consent to participate in the study

You may not qualify if:

  • \- Interns and visiting healthcare workers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khmer-Soviet Friendship Hospital

Phnom Penh, 12306, Cambodia

RECRUITING

Related Publications (1)

  • Oy S, Saing CH, Ung M, Zahari M, Nouhak I, Kim S, Nagashima-Hayashi M, Khuon D, Koy V, Mam S, Sayasone S, Saphonn V, Yi S. Developing an infection prevention and control intervention to reduce hospital-acquired infections in Cambodia and Lao People's Democratic Republic: the HAI-PC study protocol. Front Public Health. 2023 Sep 20;11:1239228. doi: 10.3389/fpubh.2023.1239228. eCollection 2023.

Central Study Contacts

Sreymom Oy, MSc

CONTACT

Chan Hang Saing, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 21, 2022

Study Start

April 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations