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Enhanced Tuberculosis Case Detection Among Substitution Treatment Patients (TBIDU)

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
Case management approach in referral to health care services
Sponsored by
National Institute for Health Development, Estonia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tuberculosis focused on measuring Tuberculosis, Injecting drug users, Case management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Participation in substitution treatment program,
  • Age 18 years or more,
  • Able to read and write in Estonian or Russian,
  • Able to provide informed consent

Sites / Locations

  • LLC Corrigo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Active referral

Passive referral

Arm Description

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.

Participants were instructed to schedule an appointment with TB services themselves.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 3, 2011
Last Updated
February 3, 2011
Sponsor
National Institute for Health Development, Estonia
Collaborators
LLC Corrigo, Ida-Viru Central Hospital, Department of Tuberculosis
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1. Study Identification

Unique Protocol Identification Number
NCT01290081
Brief Title
Enhanced Tuberculosis Case Detection Among Substitution Treatment Patients
Acronym
TBIDU
Official Title
Prevalence of Latent Tuberculosis and Enhanced Tuberculosis Case Detection Among Injecting Drug Users Receiving Methadone Substitution Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute for Health Development, Estonia
Collaborators
LLC Corrigo, Ida-Viru Central Hospital, Department of Tuberculosis

4. Oversight

5. Study Description

Brief 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 treatment program in Estonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Tuberculosis, Injecting drug users, Case management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active referral
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Passive referral
Arm Type
No Intervention
Arm Description
Participants were instructed to schedule an appointment with TB services themselves.
Intervention Type
Other
Intervention Name(s)
Case management approach in referral to health care services
Intervention Description
Case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Participation in substitution treatment program, Age 18 years or more, Able to read and write in Estonian or Russian, Able to provide informed consent
Facility Information:
Facility Name
LLC Corrigo
City
Jõhvi
State/Province
Ida-Virumaa
ZIP/Postal Code
41532
Country
Estonia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21676222
Citation
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.
Results Reference
derived

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Enhanced Tuberculosis Case Detection Among Substitution Treatment Patients

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