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Reducing Silica Exposure Among Brick Kiln Workers in Nepal

Primary Purpose

Silicosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
N95 Respirator
Protective Eyewear
Baseline Survey
Design of Workshop
Training Workshop Pilot
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Silicosis focused on measuring Silica Exposure, Brick Kiln, Personal Protective Equipment (PPE) Program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18 years or older Active Brick Kiln Workers in Bhaktapur, Nepal Cognitively capable to provide informed consent Exclusion Criteria: Less than 18 years old Non Brick Kiln Workers Not cognitively capable to provide informed consent

Sites / Locations

  • Johns Hopkins University
  • Duke University
  • Tribhuvan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Baseline Survey: Silicosis and Personal Protective Equipment

Design of Personal Protective Equipment Training Workshop

Pilot Study: Personal Protective Equipment Training Program

Feedback Workshop on Pilot Personal Protective Equipment Training Program

Arm Description

A small training program will be offered to brick kiln workers to determine preferred PPE type, feasibility in the work environment and proper usage of PPE.

Outcomes

Primary Outcome Measures

Feasibility as assessed by The Feasibility of Intervention Measure (FIM) score
Feasibility will be measured using the Feasibility of Intervention Measure which includes 4 questions with 5-point likert response options, Completely disagree (1) - Completely agree (5). Higher score, higher agreement of feasibility.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2023
Last Updated
October 13, 2023
Sponsor
Johns Hopkins University
Collaborators
Tribhuvan University, Chiesi Foundation, National Institutes of Health (NIH), Duke University, Fogarty International Center of the National Institute of Health
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1. Study Identification

Unique Protocol Identification Number
NCT06090370
Brief Title
Reducing Silica Exposure Among Brick Kiln Workers in Nepal
Official Title
Reducing Silica Exposure Among Brick Kiln Workers in Nepal: A Human-centered Design Framework to Develop a Personal Protective Equipment Training Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Tribhuvan University, Chiesi Foundation, National Institutes of Health (NIH), Duke University, Fogarty International Center of the National Institute of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Inhaling respirable silica increases the risk for silicosis, an incurable and debilitating lung disease. In South Asia, one high-risk industry is brick manufacturing, where more than 4 million manual laborers mold bricks by hand. In Nepal, brick manufacturing employs over 200,000 workers across 1,200 registered brick kilns. These workers are exposed to respirable silica concentrations 1.4 to 6.6 times higher than the limits set by the U.S. National Institute for Occupational Safety and Health. Preventing silicosis is paramount, as the average brick kiln worker cannot afford medical care and only 6.8% receive regular health checks. Few studies have evaluated interventions in brick kiln workers to reduce silica exposure and prevent silicosis. One promising intervention involves providing workers who are exposed to silica above the permissible exposure limit with personal protective equipment (PPE), specifically respirators. When properly used, respirators decrease silica inhalation and the risk of silicosis. Brick kiln workers in Nepal do not use any PPE. Several studies have explored PPE barriers and have evaluated the feasibility of implementing PPE but to date none have been conducted in Nepali brick kiln workers. To close this gap, the goal of this research is a human-centered design approach to develop and pilot a PPE training program in one brick kiln in Nepal guided by the Discover, Design, Build, and Test (DDBT) framework. This research is necessary to understand the Nepali context and to efficiently develop appropriate and feasible PPE intervention components that will be trialed in future research.
Detailed Description
Workers will be recruited from Bhaktapur, a district in the Kathmandu Valley. The investigators will conduct a four-part study. Part 1 will involve a quantitative, cross-sectional survey to understand baseline worker perceptions on silicosis and personal protective equipment (PPE). Part 2 will comprise qualitative co-creation human-centered design workshops to elicit feedback on PPE training prototypes and types of PPE. Part 3 will be a small feasibility pilot of the training program and most preferred type of PPE. Part 4 will comprise qualitative workshops to elicit feedback on the piloted PPE training program. The same participants may participate in Part 1 and 2. Participants in Part 3 will be a distinct group from those who participated in Parts 1 and 2. Participants in Part 4 will also be distinct group from Parts 1, 2, and 3. Assessments will include: Aim 1: Characterize knowledge gaps and behaviors influencing PPE use among brick kiln workers in Bhaktapur, Nepal Method: Quantitative, cross-sectional survey to understand baseline worker perceptions on silicosis and personal protective equipment (PPE). N = 100 workers. Aim 2: Design a personal protective equipment (PPE) training program for brick kiln workers in Nepal through a human-centered design approach Method: 4 qualitative co-creation human-centered design workshops. N = 20 - 40 workers. Aim 3: Evaluate acceptability, appropriateness, and feasibility of personal protective equipment (PPE) training through a pilot among brick kiln workers in Nepal Method: Feasibility pilot study at 1 brick kiln for 1 month. N = 20 workers (intervention) and N = 20 workers (control). 2 qualitative co-creation human-centered design workshops to elicit feedback after the pilot. N = 10 - 20 workers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Silicosis
Keywords
Silica Exposure, Brick Kiln, Personal Protective Equipment (PPE) Program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baseline Survey: Silicosis and Personal Protective Equipment
Arm Type
Experimental
Arm Title
Design of Personal Protective Equipment Training Workshop
Arm Type
Experimental
Arm Title
Pilot Study: Personal Protective Equipment Training Program
Arm Type
Experimental
Arm Description
A small training program will be offered to brick kiln workers to determine preferred PPE type, feasibility in the work environment and proper usage of PPE.
Arm Title
Feedback Workshop on Pilot Personal Protective Equipment Training Program
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
N95 Respirator
Intervention Description
The participants in this group will be provided with N95 respirator masks to protect from dust and debris while working in the brick kiln and trained on proper usage.
Intervention Type
Device
Intervention Name(s)
Protective Eyewear
Intervention Description
The participants in this group will be provided with eye wear to protect the eyes from dust and debris while working in the brick kiln and trained on proper usage
Intervention Type
Other
Intervention Name(s)
Baseline Survey
Intervention Description
A quantitative, cross-sectional survey will be distributed to enrolled participants to understand baseline worker perceptions on silicosis and personal protective equipment (PPE).
Intervention Type
Other
Intervention Name(s)
Design of Workshop
Intervention Description
A co-creation human centered design workshop to elicit feedback on PPE training prototypes and types of PPE.
Intervention Type
Other
Intervention Name(s)
Training Workshop Pilot
Intervention Description
Qualitative workshops will be held to elicit feedback on the piloted PPE training program.
Primary Outcome Measure Information:
Title
Feasibility as assessed by The Feasibility of Intervention Measure (FIM) score
Description
Feasibility will be measured using the Feasibility of Intervention Measure which includes 4 questions with 5-point likert response options, Completely disagree (1) - Completely agree (5). Higher score, higher agreement of feasibility.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Active Brick Kiln Workers in Bhaktapur, Nepal Cognitively capable to provide informed consent Exclusion Criteria: Less than 18 years old Non Brick Kiln Workers Not cognitively capable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Checkley, MD, PhD
Phone
+1 443-287-4587
Email
wcheckl1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Miller
Phone
+1 443-287-4235
Email
emille76@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Checkley, MD, PhD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Checkley, MD, PhD
Phone
443-287-4587
Email
wcheckl1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Erika Miller, MHS
Phone
+1 443-287-4235
Email
emille76@jhmi.edu
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chelsea Gaviola, MD
Email
chelsea.gaviola@duke.edu
Facility Name
Tribhuvan University
City
Maharajgunj
State/Province
Kathmandu
Country
Nepal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laxman P Shrestha, MD
Phone
+977 01-4412202
Email
laxmanshree12@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Reducing Silica Exposure Among Brick Kiln Workers in Nepal

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