Silicosis Treatment, Action, Screening and Surveillance in Rwanda Trials

NCT05538299 | Unknown

• 1 other identifier: IMB-sil1
• Study Type: observational
• Target: 995
• Locations: 1 country
• Sites: 1

Brief Summary

Silicosis is the most prevalent occupational lung disease in low- and middle-income countries (LMICs) with "tens of millions" estimated to suffer from the disease according to the World Health Organization (WHO). To date, there is little published data on silicosis in LMICs and the burden of silicosis in Rwanda has not been well-defined. Silicosis among local mine workers is a common reason for hospitalization and death at Rwinkwavu District Hospital, located in Rwanda's Kayonza District. The objectives of this study are:

1. 1.To assess the prevalence of silicosis among workers in four mines located in the Kayonza District of Rwanda
2. 2.To adapt a validated screening tool testing in Dutch construction workers for Rwandan miners
3. 3.To implement an occupational health education program and assess the change of before and after intervention that target towards proper use of PPE and individual risk assessment in mine workers using knowledge-attitudes-practice tool

Conditions

Silicosis; Silicotic Fibrosis (Massive) of Lung

Outcome Measures

Primary Outcomes (1)

• Silicosis Prevalence

  Estimate Silicosis prevalence in the Eastern Province of Rwanda

  6 months

Secondary Outcomes (2)

• Questionnaire Validation

  1 year

• Knowledge, Action, Prevelence

  1 year

Interventions

questionnaire, KAP BEHAVIORAL

Diagnostic studies including questionaire, CXR, spirometry, clinical assesment, occupational safety training

Also known as: diagnostic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All eligible mine workers in Kayonza District in four sectors including: Rwinkwavu, Murama, Ruramira, and Mwiri sectors, located in the Rwinkwavu DH catchment area will be included in the study. Those miners with potential risk for RCS exposure, including those who handle mining either underground or above ground will be included. People who work in WOLFRAM administration (office) and never directly touch mines will not be included.

You may qualify if:

• Miners with greater than 1 year of potential exposure to respirable crystalline silica within the defined catchment area of the study

You may not qualify if:

• non-mining (administrative, low risk of exposure) workers within the WOLFRAM (mining company) catchment area

Sponsors & Collaborators

• Samuel Hatfield: lead

Study Sites (1)

Rwinkwavu District Hospital

Rwinkwavu, Kayonza, Rwanda

RECRUITING

Related Publications (1)

• Suarthana E, Moons KG, Heederik D, Meijer E. A simple diagnostic model for ruling out pneumoconiosis among construction workers. Occup Environ Med. 2007 Sep;64(9):595-601. doi: 10.1136/oem.2006.027904. Epub 2007 Apr 4.

  PMID: 17409183 BACKGROUND

MeSH Terms

Conditions

Silicosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

• Innocent Kamali

  Partners in Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Tumusime

CONTACT

250788597448; rtumusime@pih.org

Samuel Hatfield

CONTACT

808-497-2509; shatfields@pih.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: July 31, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 31, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: the investigators plan to make data public 6-9 months following the completion of the study and accessible for up to 3 years
• Access Criteria: Access will be granted to qualified and interested researchers who approach the investigators directly following the conclusion of the study. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data will be de-identified for protection of PHI

Locations

RW (1)