Reducing the prevalence of tuberculosis (TB) in a highly endemic setting by community-wide active case finding

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000372684
• Date of registration: 08/04/2014
• Prospective Registration: No
• Primary sponsor: Woolcock Institute of Medical Research
• Public title: Reducing the prevalence of tuberculosis (TB) in a highly endemic setting by community-wide active case finding
• Scientific title: In regions that are highly endemic for tuberculosis (TB), does community-wide active case finding, compared with routine TB control program activities, reduce the prevalence of pulmonary TB in adults and the prevalence of TB infection in children?
• Date of first enrolment: 28/03/2014
• Target sample size: 120000
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000372684.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Viet Nam

Contacts

• Name: Prof Guy B. Marks

• Name: Prof Guy B Marks

Key inclusion & exclusion criteria

Inclusion criteria: The primary unit of randomisation is the cluster. All clusters (sub-communes) within the Province of Ca Mau, Vietnam, are eligible for selection.
Within each cluster all persons aged 15 years and over who are capable of giving informed consent are eligible.
Exclusion criteria: Unable to give informed consent

Age minimum: 15 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Respiratory - Other respiratory disorders / diseases

Tuberculosis;
Tuberculosis

Infection - Other infectious diseases

Intervention(s)

Adult residents of intervention clusters will be screened for TB once per year for three years.
Eligible residents within each cluster will be persons aged 15 years and over who are capable of giving informed consent and who are resident in the cluster at the time of screening.
Residents will be visited in their home, informed about the study and, if they agree to be screened, will answer questions about symptoms of TB and attempt to produce a single spontaneous sputum specimen for testing. The collected sputum specimen will be tested for Mycobacterium tuberculosis using a fully automated polymerase chain reaction (PCR) (Xpert MTB/RIF, Cepheid Inc). Those who test positive will be referred to the TB treatment program for further management. We will conduct a public information campaign within the selected intervention clusters to enhance participation in the screening process. This will include meeting with community leaders, announcements broadcast over loudspeakers in the village and distributing information flyers to households.

Primary Outcome(s)

Prevalence of microbiologically-confirmed pulmonary tuberculosis[In the fourth year of the study]

Prevalence of tuberculosis infection in children aged six years and below[In the fourth year of the study]

Secondary Outcome(s)

Transmission index, that is, the average number of secondary cases per index case. Secondary cases are additional cases of TB that are assumed to have arisen due to infection by the index case. [During the four years of the study]

Secondary ID(s)

None

Source(s) of Monetary Support

National Health and Medical Research Council (Australia)

Secondary Sponsor(s)

National Lung Hospital, Vietnam

Ethics review

Status: Approved
Approval date:
Contact:

National Lung Hospital, Vietnam, Research Ethics Committee

Status: Approved
Approval date:
Contact:

University of Sydney Human Research Ethics Committee