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Trial registered on ANZCTR


Registration number
ACTRN12619001439134
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
17/10/2019
Date last updated
17/10/2019
Date data sharing statement initially provided
17/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study for universal testing and treatment of Latent Tuberculosis Infection (LTBI)
Scientific title
A pilot study for universal testing and treatment of LTBI
Secondary ID [1] 298300 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACT5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Latent Tuberculosis Infection 312929 0
Condition category
Condition code
Respiratory 311420 311420 0 0
Other respiratory disorders / diseases
Infection 312921 312921 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The initial treatment regimen will be 4RIF as this is currently approved and available. When 3HP is approved and available, we will switch to that regimen.

RIF regimen: 18 weeks of oral treatment with rifampicin (600mg/day for > 50 kg or 400mg/day < 50 kg body weight) as a single daily dose dispensed weekly at the participants home by a study team member.

If during the pilot study we receive approval for the use of a new treatment regimen we will commence new participants on this regimen.
3HP regimen: 12 weeks of oral treatment administered once a week with isoniazid (15mg/kg, with 900mg maximum dose) and rifapentine (900mg if greater than or equal to 50Kg, otherwise 15mg/kg if aged > 12 years)

Screening for LTBI will be performed as the part if the study. Screening involves implementation of an tuberculin skin test (TST) using the Mantoux technique. The TST is performed by injecting a small amount of tuberculin under the skin on the participants forearm. 48-72 hours after injection the test site is checked and the size of any lump will determine whether the test is positive or negative.

Participants who do not have a positive TST will not be offered any LTBI treatment. However, if they have symptoms of TB, they will be screened for TB disease.

TEST phase
Screening for LTBI infection

TREAT phase
Treatment of LTBI in those who screen positive for LTBI.
Intervention code [1] 314533 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320139 0
Proportion of eligible patients who complete at least 80% of doses of the required treatment, via record of drug delivery (directly observed therapy)
Timepoint [1] 320139 0
18 weeks from treatment initiation for RIF regimen and 12 weeks from treatment initiation for 3HP regimen
Secondary outcome [1] 370673 0
Proportion of the census population that meet the eligibility criteria (for the screening phase)
Timepoint [1] 370673 0
At completion of screening phase
Secondary outcome [2] 370674 0
The proportion of the eligible population in whom "Informed consent"" is obtained to participate in the study
Timepoint [2] 370674 0
At completion of screening phase
Secondary outcome [3] 370675 0
The proportion of the eligible population in whom data on TB symptoms are acquired
Timepoint [3] 370675 0
At completion of screening phase
Secondary outcome [4] 370676 0
The proportion of the eligible population in whom a TB skin test is placed
Timepoint [4] 370676 0
At completion of the screening phase
Secondary outcome [5] 370677 0
The proportion of the eligible population in whom a TB skin test is read
Timepoint [5] 370677 0
At completion of screening phase
Secondary outcome [6] 370678 0
The proportion of persons with a positive test for LTBI in whom screening for active TB disease is completed
Timepoint [6] 370678 0
At completion of screening phase
Secondary outcome [7] 370679 0
The proportion of persons, who are eligible for treatment for LBTI, who provide consent to commence treatment
Timepoint [7] 370679 0
At completion of the study
Secondary outcome [8] 370680 0
The proportion of persons, who are eligible for treatment for LBTI, who ingest at least one dose of treatment under observation
Timepoint [8] 370680 0
At completion of the study
Secondary outcome [9] 370681 0
The proportion of persons, who are eligible for treatment for LBTI, who complete treatment
Timepoint [9] 370681 0
At completion of study
Secondary outcome [10] 370683 0
The proportion of persons, who are eligible for treatment for LBTI, who were asked by the investigators to prematurely permanently discontinued treatment
Timepoint [10] 370683 0
At completion of the study
Secondary outcome [11] 370684 0
The proportion of persons, who are eligible for treatment for LBTI, who permanently discontinue treatment prior to completion, without being asked to do so by the investigators
Timepoint [11] 370684 0
At completion of the study
Secondary outcome [12] 370685 0
The proportion of persons, who are eligible for treatment for LBTI, who report Grade 3 or 4 adverse reactions. Information on adverse events will be acquired from a) pre-treatment symptom questionnaire; b) scheduled liver function tests and full blood count in individuals stratified as being at high risk; c) reports from patients or their carers or medical attendants.
Timepoint [12] 370685 0
Participants followed up for adverse events for 18 weeks from treatment initiation for RIF regimen and 12 weeks from treatment initiation for 3HP regimen

Eligibility
Key inclusion criteria
Resident in any of three selected Aps in Ca Mau Province, Vietnam
Minimum age
15 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for the TEST phase;
No exclusion criteria for the test phase.

Exclusion criteria for the TREAT phase;
* Pregnant women or women planning and attempting to fall pregnant
* Active TB

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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] 21516 0
Viet Nam
State/province [1] 21516 0
Ca Mau

Funding & Sponsors
Funding source category [1] 302842 0
Government body
Name [1] 302842 0
National Health and Medical Research Council
Address [1] 302842 0
Level 1
16 MARCUS CLARKE STREET,
Canberra, Australian Capital Territory, 2601
Country [1] 302842 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road,
Glebe, NSW, 2037
Country
Australia
Secondary sponsor category [1] 302790 0
None
Name [1] 302790 0
Address [1] 302790 0
Country [1] 302790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303420 0
The University of Sydney, Human Research Ethics Committee
Ethics committee address [1] 303420 0
Research integrity and ethics
The University of Sydney
NSW 2006
Ethics committee country [1] 303420 0
Australia
Date submitted for ethics approval [1] 303420 0
31/05/2019
Approval date [1] 303420 0
16/07/2019
Ethics approval number [1] 303420 0
2019/515

Summary
Brief summary
This study is a pilot study for a proposed community-based cluster-randomised controlled trial of universal testing and treatment for latent TB infection, together with active case finding for TB disease, to reduce the prevalence of TB. The aim of this pilot study is to develop the detailed procedures for implementing the universal testing for, and treatment of, LTBI infection and to demonstrate the feasibility, safety and acceptability in preparation for the RCT.

The study will be conducted in three Aps (sub-communes) in South Vietnam. All community members will be screened for LTBI infection and those who have evidence of LTBI will be offered drug treatment. The primary outcome will be the proportion of eligible participants with LTBI who completed at least 80% of the scheduled doses of drug treatment. Secondary outcomes include indices of participation and acceptability of the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93618 0
Prof Guy Marks
Address 93618 0
Woolcock Institute of Medical Research,
Box M77 Missenden Road Post Office
Camperdown, NSW, 2050
Country 93618 0
Australia
Phone 93618 0
+61419251565
Fax 93618 0
+61 2 9114 0011
Email 93618 0
g.marks@unsw.edu.au
Contact person for public queries
Name 93619 0
Prof Guy Marks
Address 93619 0
Woolcock Institute of Medical Research,
Box M77 Missenden Road Post Office
Camperdown, NSW, 2050
Country 93619 0
Australia
Phone 93619 0
+61419251565
Fax 93619 0
+61 2 9114 0011
Email 93619 0
g.marks@unsw.edu.au
Contact person for scientific queries
Name 93620 0
Prof Guy Marks
Address 93620 0
Woolcock Institute of Medical Research,
Box M77 Missenden Road Post Office
Camperdown, NSW, 2050
Country 93620 0
Australia
Phone 93620 0
+61419251565
Fax 93620 0
+61 2 9114 0011
Email 93620 0
g.marks@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 4716 0
Study protocol
Citation [1] 4716 0
Link [1] 4716 0
Email [1] 4716 0
Other [1] 4716 0
Type [2] 4717 0
Informed consent form
Citation [2] 4717 0
Link [2] 4717 0
Email [2] 4717 0
Other [2] 4717 0
This informed consent form is for the TEST phase of the trial. Participants here are providing consent to have a Tuberculin Skin Test for LTBI.
Type [3] 4718 0
Informed consent form
Citation [3] 4718 0
Link [3] 4718 0
Email [3] 4718 0
Other [3] 4718 0
This informed consent form is for the TREAT phase of the trial. Participants here are providing consent to have receive drug treatment for LTBI.
Type [4] 4719 0
Ethical approval
Citation [4] 4719 0
Link [4] 4719 0
Email [4] 4719 0
Other [4] 4719 0
Summary results
No Results