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Completed

NCT Number: NCT06090370

Reducing Silica Exposure Among Brick Kiln Workers in Nepal

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.

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Key information

Conditions

Silicosis Lung Diseases Lung Diseases, Interstitial Lung Injury Occupational Diseases Pneumoconiosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tribhuvan University, Maharajgunj, Kathmandu, Nepal

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N95 Respirator

Device

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

Device

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

Baseline Survey

Other

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

Other

A co-creation human centered design workshop to elicit feedback on PPE training prototypes and types of PPE.

Training Workshop Pilot

Other

Qualitative workshops will be held to elicit feedback on the piloted PPE training program.

Primary outcomes

  1. Feasibility as assessed by The Feasibility of Intervention Measure (FIM) score

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Chiesi Foundation
  • Duke University
  • Fogarty International Center of the National Institute of Health
  • National Institutes of Health (NIH)
  • Tribhuvan University, Nepal

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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