NCT01290081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
Last Updated

February 4, 2011

Status Verified

January 1, 2008

Enrollment Period

3 months

First QC Date

February 3, 2011

Last Update Submit

February 3, 2011

Conditions

Tuberculosis

Keywords

TuberculosisInjecting drug usersCase management

Study Arms (2)

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.

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.

Other: Case management approach in referral to health care services

Interventions

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

Active referralPassive referral

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LLC Corrigo

Jõhvi, Ida-Virumaa, 41532, Estonia

Location

Related Publications (1)

  • 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.

    PMID: 21676222DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 4, 2011

Study Start

October 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 4, 2011

Record last verified: 2008-01

Locations

ES(1)