Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06090370
Study type Interventional
Source Johns Hopkins University
Contact William Checkley, MD, PhD
Phone +1 443-287-4587
Email wcheckl1@jhmi.edu
Status Recruiting
Phase N/A
Start date January 24, 2024
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT01329003 - DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone) N/A
Not yet recruiting NCT01338064 - Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone) N/A
Recruiting NCT04161014 - The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial Phase 2
Recruiting NCT05118256 - Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis Phase 2
Completed NCT02430259 - Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention Phase 3
Not yet recruiting NCT06011785 - Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil Early Phase 1
Not yet recruiting NCT05402176 - The SHIELD Whole Lung Lavage Study
Completed NCT02794701 - Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
Completed NCT01977131 - Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis Phase 1/Phase 2
Completed NCT00005280 - Specialized Center of Research in Occupational and Immunologic Lung Disease N/A
Recruiting NCT05538299 - Silicosis Treatment, Action, Screening and Surveillance in Rwanda Trials
Completed NCT01725971 - Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis N/A
Completed NCT04205708 - Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
Recruiting NCT05546944 - The SHIELD Study-silicosis