Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000264088
Ethics application status
Approved
Date submitted
25/03/2010
Date registered
31/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the revised World Health Organization recommendations and algorithms for the diagnosis of tuberculosis in Human immunodeficiency virus prevalent settings
Scientific title
Evaluation of the operational performance of the revised World Health Organization (WHO) recommendations and algorithms for improving the diagnosis of tuberculosis in human immunodeficiency virus prevalent settings, Ethiopia
Secondary ID [1] 1551 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis(TB) 257039 0
Humman Immuno-defficiency Virus(HIV) 257053 0
Condition category
Condition code
Infection 257196 257196 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis of smear negative tuberculosis (TB) in HIV patients is a challenge for developing countries. Recently, the World Health organization(WHO) has recommended a new guideline to diagnose TB in such settings. The already exisiting guideline(WHO,2003) is inefficient to diagnose TB in HIV Patients. The 2003 guideline recommends the following to diagnose TB in adult HIV patients: three sputum examination, antibiotic trial if the three sputa are negative, repetition of sputum examination after antibiotic trial and finally X-ray for the diagnosis of TB. Based on this guideline, at least two sputa should be positive to diagnose TB or there should be evdidences of antibiotic trial failure, X-ray suggestion and physician decision to diagnose TB. On the other hand, the new guideline (WHO, 2006) recommends that HIV adult patients should have only two sputum examination, if one of them is positive, TB is confirmed. If the two sputa are negative, X-ray and culture should be done in the second visit. Based on the X-ray and culture results, patients shoud be treated immediately. Antibiotic trial is not recommended. However, the new guideline is not based on evidence. It is based on experts' opinion. This study will compare the two guidelines in terms of patients' satisfaction, treatment delay and mortality. Two hospitals will implement the 2006 WHO guideline to diagnose tuberculosis in patients with HIV. Two other comparasion hospitals will implement the 2003 WHO guideline to diagnose tuberculosis in HIV patients. We will compare treatment delay, proportion of smear negative TB , mortality between the two settings. The total duration of patient recruitment and follow up will be 2 years
Intervention code [1] 256219 0
Not applicable
Comparator / control treatment
The controls are the two hospitals which implement the 2003 WHO guideline to diagnose tuberculosis
Control group
Active

Outcomes
Primary outcome [1] 258089 0
Proportion of smear negative tuberculosis(TB) bieng diagnosed.
Timepoint [1] 258089 0
This outcome will be assessed one month after recruitment using sputum examination and culture
Primary outcome [2] 258092 0
Treatment delay
Timepoint [2] 258092 0
This outcome will be assessed one month after recruitment using questionnaire
Primary outcome [3] 258093 0
Client satisfaction
Timepoint [3] 258093 0
Client satisfaction will be evaluated one month after recruitment by interview using questionnaire
Primary outcome [4] 258094 0
Mortality
Timepoint [4] 258094 0
Mortality will be evaluated at 2, 6, and 8 months after recruitment using record review and verbal autopsy
Secondary outcome [1] 263697 0
Acceptance rate of HIV testing among TB suspects
Timepoint [1] 263697 0
Acceptance rate will be assessed one month after recruitment using questionaire
Secondary outcome [2] 263699 0
Cost effectiveness analysis for the study hospitals
Timepoint [2] 263699 0
It will be determined at the end of the study(year 2) by record review and interview

Eligibility
Key inclusion criteria
Settings which had TB culture facility will be included to implement the 2006 WHO TB guideline. TB suspects who are above 15 years will be included.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Tuberculosis suspects below 15 years will be excluded

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3236
Accrual to date
Final
Recruitment outside Australia
Country [1] 2559 0
Ethiopia
State/province [1] 2559 0

Funding & Sponsors
Funding source category [1] 256714 0
Commercial sector/Industry
Name [1] 256714 0
United Nations Children's Fund/United Development Program/World Health Organization/World Bank-Research and Training in Tropical Diseases(TDR)
Country [1] 256714 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
United Nations Children's Fund/United Development Program/World Health Organization/World Bank-Research and Training in Tropical Diseases(TDR)
Address
Dr. Pascal Launois,
TDR/EPM,
World Health Organization,
20 Avenue Appia,
1211 Geneva 27,
Geneva,
Switzerland
Country
Switzerland
Secondary sponsor category [1] 256002 0
Government body
Name [1] 256002 0
Institutional University Cooperation-Jimma University(IUC-JU) projects
Address [1] 256002 0
Jimma University, Oromiya regional state
P.O.BOX 378, Jimma
Ethiopia
Country [1] 256002 0
Ethiopia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258727 0
National Ethical committee, Ministry of Science and Technology, Ethiopia
Ethics committee address [1] 258727 0
Ethics committee country [1] 258727 0
Ethiopia
Date submitted for ethics approval [1] 258727 0
10/11/2008
Approval date [1] 258727 0
13/07/2009
Ethics approval number [1] 258727 0
RDHE/99-88/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30984 0
Address 30984 0
Country 30984 0
Phone 30984 0
Fax 30984 0
Email 30984 0
Contact person for public queries
Name 14231 0
Amare Deribew Taddege
Address 14231 0
Jimma Univeversity, Oromiya Regional state
P.O.Box 378,
Jimma,
Ethiopia
Country 14231 0
Ethiopia
Phone 14231 0
+251471120945
Fax 14231 0
Email 14231 0
[email protected]
Contact person for scientific queries
Name 5159 0
Amare Deribew Taddege
Address 5159 0
Jimma Univeversity, Oromiya Regional state
P.O.Box 378,
Jimma,
Ethiopiapia
Country 5159 0
Ethiopia
Phone 5159 0
+251471120945
Fax 5159 0
Email 5159 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.