ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tuberculosis(TB)

Humman Immuno-defficiency Virus(HIV)

Condition category

Condition code

Infection

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]

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]

Proportion of smear negative tuberculosis(TB) bieng diagnosed.

Timepoint [1]

This outcome will be assessed one month after recruitment using sputum examination and culture

Primary outcome [2]

Treatment delay

Timepoint [2]

This outcome will be assessed one month after recruitment using questionnaire

Primary outcome [3]

Client satisfaction

Timepoint [3]

Client satisfaction will be evaluated one month after recruitment by interview using questionnaire

Primary outcome [4]

Mortality

Timepoint [4]

Mortality will be evaluated at 2, 6, and 8 months after recruitment using record review and verbal autopsy

Secondary outcome [1]

Acceptance rate of HIV testing among TB suspects

Timepoint [1]

Acceptance rate will be assessed one month after recruitment using questionaire

Secondary outcome [2]

Cost effectiveness analysis for the study hospitals

Timepoint [2]

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?

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]

Ethiopia

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

United Nations Children's Fund/United Development Program/World Health Organization/World Bank-Research and Training in Tropical Diseases(TDR)

Address [1]

Dr. Pascal Launois,
TDR,
World Health Organization,
20 Avenue Appia,
1211 Geneva 27,
Geneva,
Switzerland

Country [1]

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]

Government body

Name [1]

Institutional University Cooperation-Jimma University(IUC-JU) projects

Address [1]

Jimma University, Oromiya regional state
P.O.BOX 378, Jimma
Ethiopia

Country [1]

Ethiopia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Ethical committee, Ministry of Science and Technology, Ethiopia

Ethics committee address [1]

Ministry of Scieince and Technology, Ethiopia
P.O.BOX 2490
Addis Ababa, Ethiopia

Ethics committee country [1]

Ethiopia

Date submitted for ethics approval [1]

10/11/2008

Approval date [1]

13/07/2009

Ethics approval number [1]

RDHE/99-88/2009

Summary

Brief summary

Background-Ethiopia is a highly affected country by HIV/AIDS epidemic among Sub-Saharan countries with a prevalence rate of 2.2%.  The rate of TB/HIV coinfection in Ethiopia is also very high ranging from 40-70%. The majority of the TB patients are smear negative and/or extra pulmonary. The existing guideline of Ethiopia did not adequately reflect the diagnostic and treatment challenges of smear negative and/or HIV-associated tuberculosis. Currently WHO has recommended new guideline (2006) for the diagnosis of HIV-associated tuberculosis. However, this guideline is based on expert opinion and consensus. 
Objective- The objective of this study is to assess the operational performance of the revised recommendations and algorithm for improving the diagnosis of TB in HIV prevalent setting in selected hospitals of two regional states in Ethiopia. 
Methods- The study will employ quasi-experimental study (pretest and post test design) which will be conducted in four settings in Ethiopia. In Jimma and Alert hospitals where there is TB culture facility, the new guideline will be implemented.  Nekemet and Zewuditu Memorial Hospitals will be selected as a comparison group. In these hospitals, TB management will continue based on the old (2003) guideline. Similarity of the population, patient flow, availability of TB and ART clinics and accessibility were the criteria to select these hospitals as a comparison group. In settings where the new guideline is implemented, all health professionals (medical doctors, nurses, laboratory and X-ray technicians) will be trained about the new guideline using a training manual. Strict observation of the application of the new guideline will be made by trained physicians regularly using observation checklist. Refreshing training on the old guideline will be given to the health professionals who are working in settings where the old guideline is implemented. 
In both settings, about 3236 TB suspects will be recruited and followed regularly to measure different outcomes. In settings where the new guideline is being implemented, all TB suspects will have two sputum examination using the standard Ziehl-Neelsen technique and HIV counseling and testing. Smear positive individuals based on the new guideline will be referred for Directly Observed Therapy for Short Course(DOTS) therapy. Culture and/or X-ray investigations will be done for smear negative individuals or individuals with extra-pulmonary TB on the second day of their visit. In settings where the 2003 guideline is being implemented, the usual procedure of patient diagnosis and treatment process will be applied.
After recruitment of patients, in both settings, there will be regular follow up of patients.  Clinical status and progress (such as weight, functional score/WHO staging, occurrence of opportunistic infections, trends in CD4 lymhocyte count, drug adherence and side effects, and death) will be monitored regularly. 
Several outcomes will be measured. In both settings, exit interviews using structured questionnaires will be done to measure client satisfaction. In-depth interviews will be done to measure satisfaction of the health professionals with the service in both settings. Treatment delay will be using record review. Hospitalization rate will be assessed using observation checklist and record review. Mortality of patients will be measured using standardized verbal autopsy tools or death certificate. Specificity of the new guideline will be computed using culture as a gold standard diagnostic technique. 
To minimize error, the data will be entered into Epi Info 3.3.2 statistical software. Analysis will be done using SPSS 12.0.1. Descriptive analysis will be done to measure the HIV/TB co- infection, patient satisfaction rate, treatment delay rates, and the level of knowledge and attitude of the TB patients about the disease. Bivariate analysis will be done to see the effect of implementing the new guideline (as compared to the old one) on patient satisfaction, treatment delay and mortality rate of patients. To control the effect of confounding variables, a multivariate technique using logistic regression will be done. 
The study is expected to document the current morbidity and mortality patterns with regard to the dual infection in this region and to improve the management of HIV related TB. The study will help to design national policy regarding the management of smear negative and extra pulmonary TB patients in HIV prevalent settings.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Amare Deribew Taddege

Address

Jimma Univeversity, Oromiya Regional state
P.O.Box 378,
Jimma,
Ethiopia

Country

Ethiopia

Phone

+251471120945

Fax

amare.deribew@ju.edu.et

Contact person for scientific queries

Name

Amare Deribew Taddege

Address

Jimma Univeversity, Oromiya Regional state
P.O.Box 378,
Jimma,
Ethiopiapia

Country

Ethiopia

Phone

+251471120945

Fax

amare.deribew@ju.edu.et

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.

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