Reducing Silica Exposure Among Brick Kiln Workers in Nepal

Silicosis Clinical Trial

Official title:

Reducing Silica Exposure Among Brick Kiln Workers in Nepal: A Human-centered Design Framework to Develop a Personal Protective Equipment Training Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090370
• Other study ID #: IRB00387104
• Secondary ID: D43TW009340
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: William Checkley, MD, PhD
• Phone: +1 443-287-4587
• Email: wcheckl1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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 3 weeks. N = 20 workers (intervention) and N = 20 workers (control). 3 qualitative co-creation human-centered design workshops to elicit feedback after the pilot. N = 10 - 20 workers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Silicosis

Intervention

Device:
• N95 Respirator
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.
• Protective Eyewear
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

Other:
• Baseline Survey
A quantitative, cross-sectional survey will be distributed to enrolled participants to understand baseline worker perceptions on silicosis and personal protective equipment (PPE).
• Design of Workshop
A co-creation human centered design workshop to elicit feedback on PPE training prototypes and types of PPE.
• Training Workshop Pilot
Qualitative workshops will be held to elicit feedback on the piloted PPE training program.

Locations

Country	Name	City	State
Nepal	Tribhuvan University	Maharajgunj	Kathmandu
United States	Johns Hopkins University	Baltimore	Maryland
United States	Duke University	Durham	North Carolina

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins University	Chiesi Foundation, Duke University, Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH), Tribhuvan University

Countries where clinical trial is conducted

United States,  Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months