Reducing Silica Exposure Among Brick Kiln Workers in Nepal

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06090370
Collaborator
Tribhuvan University (Other), Chiesi Foundation (Other), National Institutes of Health (NIH) (NIH), Duke University (Other), Fogarty International Center of the National Institute of Health (NIH)
200
3
4
13
66.7
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: N95 Respirator
  • Device: Protective Eyewear
  • Other: Baseline Survey
  • Other: Design of Workshop
  • Other: Training Workshop Pilot
N/A

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. Participants in Part 4 will also be distinct group from Parts 1, 2, and 3.

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 1 month. N = 20 workers (intervention) and N = 20 workers (control). 2 qualitative co-creation human-centered design workshops to elicit feedback after the pilot. N = 10 - 20 workers.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Reducing Silica Exposure Among Brick Kiln Workers in Nepal: A Human-centered Design Framework to Develop a Personal Protective Equipment Training Intervention
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University Baltimore Maryland United States 21287
2 Duke University Durham North Carolina United States 27710
3 Tribhuvan University Maharajgunj Kathmandu Nepal

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: William Checkley, MD, PhD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT06090370
Other Study ID Numbers:
  • IRB00387104
  • D43TW009340
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2023