SilicosisNCT06090370
Reducing Silica Exposure Among Brick Kiln Workers in Nepal
A study testing N95 Respirator, Protective Eyewear and Baseline Survey in people with Silicosis, run by Johns Hopkins University at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Silicosis
- What is being tested?
- N95 Respirator, Protective Eyewear and Baseline Survey
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Jan 2024to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Active Brick Kiln Workers in Bhaktapur, Nepal
- Cognitively capable to provide informed consent
Who cannot join
- Less than 18 years old
- Non Brick Kiln Workers
- Not cognitively capable to provide informed consent
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Duke University
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the 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.
- Conditions
- Silicosis
- Being tested
- N95 Respirator, Protective Eyewear, Baseline Survey, Design of Workshop, Training Workshop Pilot
- Keywords
- Silica Exposure, Brick Kiln, Personal Protective Equipment (PPE) Program
- Medical subject headings
- Silicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N95 RespiratorDevice
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 EyewearDevice
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 SurveyOther
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 WorkshopOther
A co-creation human centered design workshop to elicit feedback on PPE training prototypes and types of PPE.
Training Workshop PilotOther
Qualitative workshops will be held to elicit feedback on the piloted PPE training program.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Survey: Silicosis and Personal Protective Equipment | Experimental | Not described Receives: Other: Baseline Survey |
| Design of Personal Protective Equipment Training Workshop | Experimental | Not described Receives: 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. Receives: Device: N95 Respirator; Device: Protective Eyewear |
| Feedback Workshop on Pilot Personal Protective Equipment Training Program | Experimental | Not described Receives: Other: Training Workshop Pilot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start24 Jan 2024
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SilicosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Tribhuvan University, Nepal, Chiesi Foundation, National Institutes of Health (NIH), Duke University, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- William Checkley, MD, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090370
- Sponsor's protocol ID
- IRB00387104
- Other IDs
- D43TW009340
- Status last verified
- Jun 2024
- First submitted
- 12 Oct 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaviola C, Sharma AK, Lama K, Karki A, Chandyo R, Shrestha L, Parker D, Thielman NM, Ramachandran G, Thygerson SM, Beres L, Nicolaou L, Checkley W. Reducing respirable silica exposure among brick kiln workers in Nepal: a human-centred design and implementation science framework to develop and pilot a personal protective equipment intervention. Occup Environ Med. 2026 Aug 23;83(5):243-250. doi: 10.1136/oemed-2025-110582.
PubMed 42481393
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Silica Exposure Among Brick Kiln Workers in Nepal: A Human-centered Design Framework to Develop a Personal Protective Equipment Training Intervention
- ClinicalTrials.gov ID
- NCT06090370
- Acronym / sponsor ID
- IRB00387104
- Conditions
- Silicosis
- Keywords
- Silica Exposure, Brick Kiln, Personal Protective Equipment (PPE) Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Tribhuvan University, Nepal, Chiesi Foundation, National Institutes of Health (NIH), Duke University, Fogarty International Center of the National Institute of Health
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: N95 Respirator, Device: Protective EyewearA 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. |
| Feedback Workshop on Pilot Personal Protective Equipment Training Program | Experimental | Other: Training Workshop Pilot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Active Brick Kiln Workers in Bhaktapur, Nepal
- Cognitively capable to provide informed consent
Key exclusion criteria (3 listed)
- Less than 18 years old
- Non Brick Kiln Workers
- Not cognitively capable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N95 RespiratorThe 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 | Pilot Study: Personal Protective Equipment Training Program |
| Protective EyewearThe 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 | Device | Pilot Study: Personal Protective Equipment Training Program |
| Baseline SurveyA quantitative, cross-sectional survey will be distributed to enrolled participants to understand baseline worker perceptions on silicosis and personal protective equipment (PPE). | Other | Baseline Survey: Silicosis and Personal Protective Equipment |
| Design of WorkshopA co-creation human centered design workshop to elicit feedback on PPE training prototypes and types of PPE. | Other | Design of Personal Protective Equipment Training Workshop |
| Training Workshop PilotQualitative workshops will be held to elicit feedback on the piloted PPE training program. | Other | Feedback Workshop on Pilot Personal Protective Equipment Training Program |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 42481393Gaviola C, Sharma AK, Lama K, Karki A, Chandyo R, Shrestha L, Parker D, Thielman NM, Ramachandran G, Thygerson SM, Beres L, Nicolaou L, Checkley W. Reducing respirable silica exposure among brick kiln workers in Nepal: a human-centred design and implementation science framework to develop and pilot a personal protective equipment intervention. Occup Environ Med. 2026 Aug 23;83(5):243-250. doi: 10.1136/oemed-2025-110582.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Checkley, MD, PhD principal investigator
Johns Hopkins School of Medicine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N95 Respirator, Protective Eyewear and Baseline Survey in people with Silicosis, run by Johns Hopkins University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by The Feasibility of Intervention Measure (FIM) score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.