Tuberculosis Clinical Trial
Official title:
Comparing the Accessibility of the World Health Organization's Tuberculosis Guidelines to the eTB Catalogue of Recommendations: A Two-Arm Superiority Randomized Controlled Trial
NCT number | NCT04745897 |
Other study ID # | 7908 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 26, 2021 |
Est. completion date | August 29, 2021 |
Verified date | December 2021 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The World Health Organization's Global Tuberculosis Programme (WHO-GTB) issues evidence-informed guideline recommendations on tuberculosis (TB). These recommendations are used by decision-makers, guideline developers and other stakeholders. In an effort to improve the accessibility and usability of these recommendations, a new eTB catalogue of recommendations has been developed. This study aims to compare the accessibility of the new eTB catalogue to the earlier method of accessing recommendations directed through the general WHO website.
Status | Completed |
Enrollment | 244 |
Est. completion date | August 29, 2021 |
Est. primary completion date | August 29, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Stakeholders who consider themselves to be users or potential users of tuberculosis (TB) recommendations will be eligible for participation. For the purposes of this trial, a user is defined as someone who has previously accessed TB guidelines, recommendations or policy advice, and a potential user is someone who plans to access TB guidelines, recommendations, or policy advice in the future. - Participants may be part of any group that has a stake in TB, including the public, healthcare providers, policymakers, or researchers. Participants may be from either low- and middle-income countries (LMIC) or high-income countries (HIC). - They may also vary in levels of education and previous TB work experience. Exclusion Criteria: - Individuals involved in eTB catalogue development. |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accessibility of Information on a Seven-Point Likert Scale | The primary outcome is the accessibility of information on the eTB catalogue compared to the current WHO TB guidelines. Accessibility is defined as the ability to access and use information. This outcome considers the four following domains: (1) how easy is it to find the information (2) how easy is it to understand the information (3) whether the presentation of this information facilitates decision-making (4) overall accessibility of information. These domains will be measured using a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree). The statements will be: 'It was easy to find the information', 'it was easy to understand the information', 'the information was presented in a way that would help me make a decision', and 'this website was easy to navigate'. The investigators will calculate mean composite values of these four domains for the primary outcome of accessibility, and present the four individual domains as secondary outcomes. | Duration of survey (approximately 10 minutes) | |
Secondary | Satisfaction on a Seven-Point Likert Scale | Satisfaction is defined as a stakeholder's impression of catalogue presentation. This outcome considers the three following domains: (1) home page presentation (2) recommendation list presentation (3) individual recommendation presentation. These domains will be measured using a seven-point Likert-scale (1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied). The questions will be: 'how satisfied are you with presentation of the home page?', and 'how satisfied are you with the presentation of the list of recommendations?', and 'how satisfied are you with the presentation of this individual recommendation?'. The investigators will compare means between the intervention and control groups for each domain. |
Duration of survey (approximately 10 minutes) | |
Secondary | Understanding with Multiple Choice Questions | Understanding is defined as the correct comprehension of findings. This outcome will be measured using three multiple-choice questions with four choices and one correct answer. There will be an additional option to select 'not found'. The questions will be: 'what is the recommendation strength?', 'what is the certainty of the evidence?' and 'on which page does the evidence to decision (EtD) table for this recommendation start?'. The proportion of correct responses will be compared between groups. | Duration of survey (approximately 10 minutes) | |
Secondary | Preference on a Seven-Point Likert-Scale | Preference is defined as a greater liking of one platform over the other. Participants will be provided with a demonstration of both platforms. They will subsequently answer the question 'between the WHO Tuberculosis Guidelines (current website), and the eTB Guidelines (alternative website), which do you prefer?'. This response will be measured on a Likert-scale (1 = strongly prefer WHO TB, 2 = prefer WHO TB, 3 = somewhat prefer WHO TB, 4 = same preference for WHO TB and eTB, 5 = somewhat prefer eTB, 6 = prefer eTB, 7 = strongly prefer eTB). The means will be compared between the intervention and control groups. | Duration of survey (approximately 10 minutes) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |