Intensifying Multi-Drug Resistant Tuberculosis Contact Tracing by Social Network Analysis

NCT02175849 | Completed

• 1 other identifier: 10TB
• Study Type: observational
• Target: 596
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis burden in Vietnam increasing with contribution from low detection rates and increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant Tuberculosis) among both notified TB cases and their contacts in the community. Traditional contact tracing often focuses on household contacts while strains of TB circulate in homes, schools, workplaces, and beyond. Social network Analysis (SNA) is a comprehensive approach which includes a set of persons and the connections among them used for analysis of structure of disease transmission. In this study, SNA will be used to collect network data from 60 newly detected Rifampicin resistant TB patients including an expected 50 MDR-TB patients living in Hanoi, and to identify and test potential MDR-TB cases.

Conditions

Tuberculosis Infection

Keywords

Multi-Drug Resistant Tuberculosis; Social Network Analysis

Outcome Measures

Primary Outcomes (1)

• Yield of MDR-TB case detection through SNA

  The number of MDR-TB cases notified from contacts identified by SNA and who would not have been detected by routine screening.

  Six months

Secondary Outcomes (4)

• MDR-TB incidence among subgroups of contacts

  Six months

• MDR-TB incidence among rifampicin resistant TB cases

  Six months

• MDR-TB genotype

  Six months

• Cost-effectiveness ratio of SNA and passive case finding strategies

  Six months

Study Arms (2)

Drug resistant TB patients

Patients with rifampicin resistant TB or MDR-TB newly confirmed by drug susceptibility tests (DST)

Contacts

Contacts of patients with newly detected rifampicin resistant TB or MDR-TB in households, schools, workplaces and other locations.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly detected rifampicin resistant TB or MDR-TB and their contacts

You may qualify if:

• PATIENTS: Newly detected rifampicin resistant TB or MDR-TB patients living in Hanoi for at least 3 months preceding a diagnosis made between 2013-2015.
• CONTACTS: During the 3 months before the patient's TB or MDR-TB diagnosis: all persons who spend an average of \>4 hours per day in the same residence as the patient AND/OR any individual who has had frequent and prolonged contact with the patient AND/OR anyone who has spent time in a closed environment with an MDR-TB patient
• PATIENTS AND CONTACTS: All ages
• PATIENTS AND CONTACTS: Living in Hanoi during the study period.

You may not qualify if:

• PATIENTS AND CONTACTS: Lack of informed consent for participation.

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• National Tuberculosis Program, Vietnam: collaborator

Study Sites (1)

National Lung Hospital

Hanoi, 10000, Vietnam

Location

Related Links

• Oxford University Clinical Research Unit

Biospecimen

Retention: SAMPLES WITH DNA

Sputum Gastric Aspirate

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Heiman F Wertheim, PhD

  Oxford University Clinical Research Unit - Hanoi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 26, 2014
• Study Start: December 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 15, 2016

Record last verified: 2014-07

Locations

VN (1)