Reducing Silica Exposure Among Brick Kiln Workers in Nepal

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

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.

Study Overview

• Status: Completed
• Conditions: Silicosis
• Intervention / Treatment: Other: Baseline Survey; Other: Design of Workshop; Device: N95 Respirator; Device: Protective Eyewear; Other: Training Workshop Pilot

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Kathmandu
    • Maharajgunj, Kathmandu, Nepal
      • Tribhuvan University
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baseline Survey: Silicosis and Personal Protective Equipment	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).
Experimental: Design of Personal Protective Equipment Training Workshop	Other: Design of Workshop; A co-creation human centered design workshop to elicit feedback on PPE training prototypes and types of PPE.
Experimental: Pilot Study: Personal Protective Equipment Training Program; 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.	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.; Device: 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
Experimental: Feedback Workshop on Pilot Personal Protective Equipment Training Program	Other: Training Workshop Pilot; Qualitative workshops will be held to elicit feedback on the piloted PPE training program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Duke University; National Institutes of Health (NIH); Fogarty International Center of the National Institute of Health; Chiesi Foundation; Tribhuvan University
• Investigators: Principal Investigator: William Checkley, MD, PhD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Silica Exposure; Brick Kiln; Personal Protective Equipment (PPE) Program
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Pneumoconiosis; Lung Diseases, Interstitial; Lung Injury; Silicosis
• Other Study ID Numbers: IRB00387104; D43TW009340 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No