The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000600044
Ethics application status
Approved
Date submitted
8/07/2009
Date registered
26/07/2010
Date last updated
11/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A new direction for tuberculosis control in highly endemic countries: a randomised controlled trial of active case finding
Scientific title
A randomised controlled trial to measure the impact of active case finding of tuberculosis (TB) upon the case detection rate of tuberculosis among close contacts of patients with tuberculosis in Vietnam using clinical assessment, radiology and microbiologic examination.
Secondary ID [1] 252087 0
National Health and Medical Research Council, Australia Application ID 632781.
Universal Trial Number (UTN)
Trial acronym
ACT 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tuberculosis 237184 0
Condition category
Condition code
Infection 237509 237509 0 0
Studies of infection and infectious agents
Public Health 237510 237510 0 0
Epidemiology
Respiratory 237512 237512 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Household contacts in the intervention group will receive basic education about tuberculosis and a two year programme of systematic screening and follow-up for active tuberculosis disease. These household contacts will be screened using clinical assessment and plain chest Xrays at the time of enrolment and periodically over the next 2 years. Contacts with symptoms or signs suspicious of active tuberculosis will submit sputum samples for smear and culture.
Intervention code [1] 236891 0
Early detection / Screening
Comparator / control treatment
The control group will receive routine follow-up, according to usual practices of the National Tuberculosis Program. They will receive basic education about tuberculosis at the time of enrollment.
Control group
Active

Outcomes
Primary outcome [1] 238321 0
The primary outcome measure is the case detection rate of tuberculosis among household contacts during the two year follow-up period of the trial. This is measured by clinical diagnosis (according to World Health Organization definition of active tuberculosis). A diagnosis of tuberculosis can be reached based upon clinical history and examination, chest Xray and microbiological diagnosis (sputum investigation including culture). Tuberculosis will be classified as either smear positive, smear negative or all tuberculosis. The diagnosis of tuberculosis in contacts will be classified as pulmonary tuberculosis or extra-pulmonary tuberculosis.
Timepoint [1] 238321 0
2 years from enrollment of the contacts.
Secondary outcome [1] 244711 0
Rate of pulmonary tuberculosis
Timepoint [1] 244711 0
2 years following enrollment.
Secondary outcome [2] 244712 0
Rate of culture positive tuberculosis
Timepoint [2] 244712 0
2 years following enrollment
Secondary outcome [3] 244713 0
Rate of smear positive tuberculosis
Timepoint [3] 244713 0
2 years after enrollment.
Secondary outcome [4] 244714 0
Health system costs using a cost analysis based upon questionnaires and health care costs records of participants
Timepoint [4] 244714 0
2 years after enrollment
Secondary outcome [5] 244715 0
Health care costs of contacts who develop tuberculosis during the study period, using a cost analysis based upon questionnaires and health care costs records of participants
Timepoint [5] 244715 0
2 years following recruitment
Secondary outcome [6] 244716 0
Deaths among contacts, based upon reported deaths and medical records
Timepoint [6] 244716 0
2 years following recruitment

Eligibility
Key inclusion criteria
Inclusion for index patients:
- smear positive (stain positive for acid fast bacilli on at least one sputum smear)
- aged 15 years or older

Inclusion for household contacts
- members of the household of index patients during the previous 2 months (including contact with the index patient for a minimum of 8 hours in total)
- no age limit
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion for index patients:
- primary residence outside of the geographical region of the study (due to difficulty with follow-up)
- index patient has no household contacts
- severe difficulty with communication

Exclusion for household contacts:
- not living in same household as the index patient
- already taking treatment for tuberculosis at the time of recruitment
- unwilling to participate in follow-up over 2 years of the study

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This will be a cluster-randomised controlled trial, where the unit of allocation is the District clinic. Each District will be randomised to be either a control district or a screening District.

This is an effectiveness and cost-effectiveness study.

All study participants at a given District will either be included in the control or screening group. The randomisation of each District will occur after an initial trial run-in period, in order to test faesability of the study at each District.

Patients with smear positive tuberculosis will be enrolled at the district tuberculosis clinics at the time of diagnosis or subsequent treatment. Household contacts will be enrolled when patients bring their household members to the district clinics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Districts will be selected from all available districts within the 8 provinces combined with probability proportional to population size. Within each province equal numbers of Districts will be randomised to active and control status.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1874 0
Viet Nam
State/province [1] 1874 0
District tuberculosis units from 8 Provinces / Cities including: An Giang, Binh Dinh, Can Tho, Da Nang, Ha Noi, Ho Chi Minh City, Tien Giang, Vinh Phuc.

Funding & Sponsors
Funding source category [1] 237289 0
Charities/Societies/Foundations
Name [1] 237289 0
Woolcock Institute of Medical Research, University of Sydney
Address [1] 237289 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2037
Country [1] 237289 0
Australia
Funding source category [2] 256167 0
Government body
Name [2] 256167 0
National Health and Medical Research Council, Australia
Address [2] 256167 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 256167 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council, Australia
Address
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country
Viet Nam
Secondary sponsor category [1] 236772 0
University
Name [1] 236772 0
University of Sydney, Australia
Address [1] 236772 0
Faculty of Medicine
University of Sydney NSW 2006
Country [1] 236772 0
Australia
Secondary sponsor category [2] 236774 0
University
Name [2] 236774 0
Woolcock Institute of Medical Research, University of Sydney
Address [2] 236774 0
431 Glebe Point Road
Glebe NSW 2031
Country [2] 236774 0
Australia
Other collaborator category [1] 750 0
Hospital
Name [1] 750 0
National Lung Hospital Viet Nam
Address [1] 750 0
463 Hoang Hoa Tham
Ba Dinh, Hanoi
Country [1] 750 0
Viet Nam
Other collaborator category [2] 251335 0
Government body
Name [2] 251335 0
National Tuberculosis Program, Viet Nam
Address [2] 251335 0
463 Hoang Hoa Tham
Ba Dinh, Hanoi
Country [2] 251335 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239383 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 239383 0
OFFICE OF ETHICS ADMINISTRATION
LEVEL 6
JANE FOSS RUSSELL BUILDING G02
THE UNIVERSITY OF SYDNEY NSW 2006
Ethics committee country [1] 239383 0
Australia
Date submitted for ethics approval [1] 239383 0
Approval date [1] 239383 0
20/03/2009
Ethics approval number [1] 239383 0
11554
Ethics committee name [2] 259219 0
Scientific Review Committee, National Lung Hospital, Viet Nam
Ethics committee address [2] 259219 0
463 Hoang Hoa Tham
Ba Dinh
Ha Noi
Ethics committee country [2] 259219 0
Viet Nam
Date submitted for ethics approval [2] 259219 0
Approval date [2] 259219 0
19/05/2010
Ethics approval number [2] 259219 0
235
Ethics committee name [3] 259349 0
Institutional Review Board, Ministry of Health, Vietnam
Ethics committee address [3] 259349 0
138A Giang Vo Street
Ba Dinh District
Ha Noi
Ethics committee country [3] 259349 0
Viet Nam
Date submitted for ethics approval [3] 259349 0
11/05/2010
Approval date [3] 259349 0
07/07/2010
Ethics approval number [3] 259349 0
2422/QD-BYT

Summary
Brief summary
This is a cluster-randomised controlled trial for screening household contacts of tuberculosis patients in 8 Provinces in Vietnam. It is an effectiveness and cost-effectiveness study. We will screen household contacts from districts in the intervention group regularly over a two year follow-up period and determine the case detection rate of tuberculosis disease in the screening and control groups.
Trial website
Trial related presentations / publications
Fox GJ, Nhung NV, Sy DN, et al. Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial. Trials. 2013;14(1):342.
Public notes

Contacts
Principal investigator
Name 29866 0
Prof Guy Marks
Address 29866 0
Woolcock Institute of Medical Research, University of Sydney
431 Glebe Point Road, Glebe NSW 2037
Country 29866 0
Australia
Phone 29866 0
+61 2 9114 0010
Fax 29866 0
Email 29866 0
guy.marks@sydney.edu.au
Contact person for public queries
Name 13113 0
Dr Dr Greg Fox
Address 13113 0
Woolcock Institute of Medical Research, University of Sydney
431 Glebe Point Road, Glebe NSW 2037
Country 13113 0
Australia
Phone 13113 0
+61 412 912 538
Fax 13113 0
Email 13113 0
greg.fox@sydney.edu.au
Contact person for scientific queries
Name 4041 0
Dr Dr Greg Fox
Address 4041 0
Woolcock Institute of Medical Research, University of Sydney
431 Glebe Point Road, Glebe NSW 2037
Country 4041 0
Australia
Phone 4041 0
+61 412 912 538
Fax 4041 0
Email 4041 0
greg.fox@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary