Tuberculosis InfectionSNAPNCT02175849
Intensifying Multi-Drug Resistant Tuberculosis Contact Tracing by Social Network Analysis
An observational study of Tuberculosis Infection, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis Infection
- How many people
- 596 participants
- Where
- 1 siteVietnam
- Study dates
- Dec 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly detected rifampicin resistant TB or MDR-TB and their contacts
Who may be able to join
- 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.
Who cannot join
- -PATIENTS AND CONTACTS: Lack of informed consent for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contact Tracing by Social Network Analysis to Enhance Multi-Drug Resistant Tuberculosis Case Finding in Hanoi, Vietnam
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.
Read the detailed description
The study will identify and recruit 60 newly detected Rifampicin resistant TB patients including an expected 50 MDR-TB patients living in Hanoi (index cases) who will undergo SNA of contacts and places they have stayed during 3 months preceding their TB diagnosis including residence, travel history, places of social aggregation in relation with their risk behaviour.
Patients will be interviewed to investigate contacts before the confirmation of MDR-TB (for early contact detection and minimize the risk of information lost due to patient default during treatment). Data analysis will focus on MDR-TB social networks using Cytoscape software.
After the first two enrolled Rifampicin resistant MDR-TB cases, social network data will be analyzed to identify close contacts, mutual contacts, mutual places and high risk locations. The Social Network Questionnaire (SNQ) will be contextualized to the Vietnamese setting and validated in a pilot study. Eligible contacts and locations will undergo MDR-TB screening.
Approximately 720 contacts will undergo active screening (on 2 occasions per individual: at the time of contact identification and 6 months later). Contacts will include household contacts, close contacts, mutual contacts and symptomatic individuals with significant exposure to the index case at mutual locations within a closed environment.
Contact screening will involve clinical assessment, chest X-ray and sputum or gastric aspirate collection for TB culture, molecular techniques and microbiological identification.
If contacts are screened and detected as having Rifampicin resistant TB, they will be invited to be included in SNA for further analysis.
The number of MDR-TB detected by SNA will determine whether transmission of MDR-TB not otherwise detected by routine contact investigation (only household contact tracing) is important. While traditional contact tracing practices in Vietnam mainly focus on household contacts to detect secondary cases of TB, this SNA is expected not only to identify secondary cases of MDR-TB within an extended catchment but to also identify the source cases of MDR-TB patients to " turn off the tap" of MDR-TB transmission. Moreover, the places identified as the sources of sustained transmission will be targeted for case finding along with appropriate resource allocation.
In this study analysis will focus on the costs of contact tracing with Social Network Questionnaires, the proportion of MDR-TB among eligible contacts by subgroup, the proportion of MDR-TB among Rifampicin resistant TB patients and the genotyping pattern of MDR -TB patients.
- Conditions
- Tuberculosis Infection
- Keywords
- Multi-Drug Resistant Tuberculosis, Social Network Analysis
- Medical subject headings
- Latent Tuberculosis, Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (4)
MDR-TB incidence among subgroups of contacts
The proportion of MDR-TB among eligible contacts by subgroup (household contacts, close contacts, mutual contacts, eligible contacts from mutual places with closed environment).
Measured: Six months
MDR-TB incidence among rifampicin resistant TB cases
Incidence of MDR-TB confirmed by drug susceptibility tests (DST) among rifampicin resistant TB patients.
Measured: Six months
MDR-TB genotype
Consistency or difference between TB genotype of enrolled MDR-TB patients and contacts/secondary cases.
Measured: Six months
Cost-effectiveness ratio of SNA and passive case finding strategies
The incremental cost-effectiveness ratio (ICERs) between SNA and passive case finding for one MDR-TB case detected (i.e, the cost of SNA minus the cost of passive case finding divided by the yield in terms of case detection of SNA minus the yield of passive CF)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- National Tuberculosis Program, Vietnam
- Responsible party
- Sponsor
- Investigators
- Heiman F Wertheim, PhD, Principal investigator, Oxford University Clinical Research Unit - Hanoi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175849
- Sponsor's protocol ID
- 10TB
- Acronym
- SNAP
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Tracing by Social Network Analysis to Enhance Multi-Drug Resistant Tuberculosis Case Finding in Hanoi, Vietnam
- ClinicalTrials.gov ID
- NCT02175849
- Acronym / sponsor ID
- SNAP / 10TB
- Conditions
- Tuberculosis Infection
- Keywords
- Multi-Drug Resistant Tuberculosis, Social Network Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- National Tuberculosis Program, Vietnam
- Study start
- Dec 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will identify and recruit 60 newly detected Rifampicin resistant TB patients including an expected 50 MDR-TB patients living in Hanoi (index cases) who will undergo SNA of contacts and places they have stayed during 3 months preceding their TB diagnosis including residence, travel history, places of social aggregation in relation with their risk behaviour.
Patients will be interviewed to investigate contacts before the confirmation of MDR-TB (for early contact detection and minimize the risk of information lost due to patient default during treatment). Data analysis will focus on MDR-TB social networks using Cytoscape software.
After the first two enrolled Rifampicin resistant MDR-TB cases, social network data will be analyzed to identify close contacts, mutual contacts, mutual places and high risk locations. The Social Network Questionnaire (SNQ) will be contextualized to the Vietnamese setting and validated in a pilot study. Eligible contacts and locations will undergo MDR-TB screening.
Approximately 720 contacts will undergo active screening (on 2 occasions per individual: at the time of contact identification and 6 months later). Contacts will include household contacts, close contacts, mutual contacts and symptomatic individuals with significant exposure to the index case at mutual locations within a closed environment.
Contact screening will involve clinical assessment, chest X-ray and sputum or gastric aspirate collection for TB culture, molecular techniques and microbiological identification.
If contacts are screened and detected as having Rifampicin resistant TB, they will be invited to be included in SNA for further analysis.
The number of MDR-TB detected by SNA will determine whether transmission of MDR-TB not otherwise detected by routine contact investigation (only household contact tracing) is important. While traditional contact tracing practices in Vietnam mainly focus on household contacts to detect secondary cases of TB, this SNA is expected not only to identify secondary cases of MDR-TB within an extended catchment but to also identify the source cases of MDR-TB patients to " turn off the tap" of MDR-TB transmission. Moreover, the places identified as the sources of sustained transmission will be targeted for case finding along with appropriate resource allocation.
In this study analysis will focus on the costs of contact tracing with Social Network Questionnaires, the proportion of MDR-TB among eligible contacts by subgroup, the proportion of MDR-TB among Rifampicin resistant TB patients and the genotyping pattern of MDR -TB patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly detected rifampicin resistant TB or MDR-TB and their contacts
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -PATIENTS AND CONTACTS: Lack of informed consent for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Yield of MDR-TB case detection through SNA
Time frame: Six months
The number of MDR-TB cases notified from contacts identified by SNA and who would not have been detected by routine screening.
4 secondary outcomes
MDR-TB incidence among subgroups of contacts
Time frame: Six months
MDR-TB incidence among rifampicin resistant TB cases
Time frame: Six months
MDR-TB genotype
Time frame: Six months
Cost-effectiveness ratio of SNA and passive case finding strategies
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Oxford University Clinical Research UnitLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiman F Wertheim, PhD principal investigator
Oxford University Clinical Research Unit - Hanoi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis Infection, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield of MDR-TB case detection through SNA (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.