Reducing Silica Exposure Among Brick Kiln Workers in Nepal

NCT06090370 | Completed

• 2 other identifiers: IRB00387104D43TW009340
• Study Type: interventional
• Target: 98
• Locations: 2 countries
• Sites: 3

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.

Conditions

Silicosis

Keywords

Silica Exposure; Brick Kiln; Personal Protective Equipment (PPE) Program

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Baseline Survey: Silicosis and Personal Protective Equipment

EXPERIMENTAL

Other: Baseline Survey

Design of Personal Protective Equipment Training Workshop

EXPERIMENTAL

Other: Design of Workshop

Pilot Study: Personal Protective Equipment Training Program

EXPERIMENTAL

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; Device: Protective Eyewear

Feedback Workshop on Pilot Personal Protective Equipment Training Program

EXPERIMENTAL

Other: Training Workshop Pilot

Interventions

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.

Pilot Study: Personal Protective Equipment Training Program

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

Pilot Study: Personal Protective Equipment Training Program

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).

Baseline Survey: Silicosis and Personal Protective Equipment

Design of Workshop OTHER

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

Design of Personal Protective Equipment Training Workshop

Training Workshop Pilot OTHER

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

Feedback Workshop on Pilot Personal Protective Equipment Training Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Active Brick Kiln Workers in Bhaktapur, Nepal
• Cognitively capable to provide informed consent

You may not qualify if:

• Less than 18 years old
• Non Brick Kiln Workers
• Not cognitively capable to provide informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead
• Tribhuvan University: collaborator
• Chiesi Foundation: collaborator
• National Institutes of Health (NIH): collaborator
• Duke University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Tribhuvan University

Maharajgunj, Kathmandu, Nepal

Location

MeSH Terms

Conditions

Silicosis

Interventions

N95 Respirators; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• William Checkley, MD, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 19, 2023
• Study Start: January 24, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

US (2); NE (1)