TuberculosisTBIDUNCT01290081
Enhanced Tuberculosis Case Detection Among Substitution Treatment Patients
A study testing Case management approach in referral to health care services in people with Tuberculosis, run by National Institute for Health Development, Estonia at 1 site in Estonia.
Trial summary
The purpose of this study was to determine the prevalence of latent tuberculosis infection among injecting drug users and to conduct randomized controlled trial to evaluate a case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Case management approach in referral to health care services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEstonia
- Study dates
- Oct 2007to Jan 2008
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Participation in substitution treatment program,
- Age 18 years or more,
- Able to read and write in Estonian or Russian,
- Able to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Latent Tuberculosis and Enhanced Tuberculosis Case Detection Among Injecting Drug Users Receiving Methadone Substitution Treatment
The purpose of this study was to determine the prevalence of latent tuberculosis infection among injecting drug users and to conduct randomized controlled trial to evaluate a case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program in Estonia.
- Conditions
- Tuberculosis
- Being tested
- Case management approach in referral to health care services
- Keywords
- Tuberculosis, Injecting drug users, Case management
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case management approach in referral to health care servicesOther
Case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program
| Study group | Role | What they receive |
|---|---|---|
| Active referral | Active comparator | Case management intervention group - study personnel scheduled the TB doctor appointment for the participant, reminded to keep it, and transportation to the clinic was organized when needed. Receives: Other: Case management approach in referral to health care services |
| Passive referral | No intervention | Participants were instructed to schedule an appointment with TB services themselves. Receives: Other: Case management approach in referral to health care services |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Health Development, Estonia
- Sponsor type
- Other government
- Collaborators
- LLC Corrigo, Ida-Viru Central Hospital, Department of Tuberculosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290081
- Sponsor's protocol ID
- TBIDU-1230
- Acronym
- TBIDU
- Status last verified
- Jan 2008
- First submitted
- 3 Feb 2011
- Last updated
- 4 Feb 2011
- Results posted
- No
Publications
Ruutel K, Loit HM, Sepp T, Kliiman K, McNutt LA, Uuskula A. Enhanced tuberculosis case detection among substitution treatment patients: a randomized controlled trial. BMC Res Notes. 2011 Jun 15;4:192. doi: 10.1186/1756-0500-4-192.
PubMed 21676222
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Latent Tuberculosis and Enhanced Tuberculosis Case Detection Among Injecting Drug Users Receiving Methadone Substitution Treatment
- ClinicalTrials.gov ID
- NCT01290081
- Acronym / sponsor ID
- TBIDU / TBIDU-1230
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Injecting drug users, Case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Institute for Health Development, EstoniaOther government
- Collaborators
- LLC Corrigo, Ida-Viru Central Hospital, Department of Tuberculosis
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 4 Feb 2011 (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.
The purpose of this study was to determine the prevalence of latent tuberculosis infection among injecting drug users and to conduct randomized controlled trial to evaluate a case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program in Estonia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active referral | Active comparator | Other: Case management approach in referral to health care servicesCase management intervention group - study personnel scheduled the TB doctor appointment for the participant, reminded to keep it, and transportation to the clinic was organized when needed. |
| Passive referral | No intervention | Other: Case management approach in referral to health care servicesParticipants were instructed to schedule an appointment with TB services themselves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participation in substitution treatment program,
- Age 18 years or more,
- Able to read and write in Estonian or Russian,
- Able to provide informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case management approach in referral to health care servicesCase management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program | Other | Active referral, Passive referral |
Primary outcome
Not reported in the source record.
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 4 Feb 2011.
- Derived from this study: PubMed 21676222Ruutel K, Loit HM, Sepp T, Kliiman K, McNutt LA, Uuskula A. Enhanced tuberculosis case detection among substitution treatment patients: a randomized controlled trial. BMC Res Notes. 2011 Jun 15;4:192. doi: 10.1186/1756-0500-4-192.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management approach in referral to health care services in people with Tuberculosis, run by National Institute for Health Development, Estonia at 1 site in Estonia.
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 0 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 4 Feb 2011. 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 Estonia. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01290081, which also lists 1 linked publication.
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 4 Feb 2011.