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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02174380
Date of registration: 23/06/2014
Prospective Registration: No
Primary sponsor: Lena Shah
Public title: Effectiveness of Active Case Finding of Household Contacts in a Routine Tuberculosis (TB) Control Program
Scientific title: Cost-effectiveness of a Population-based Active TB Control Program for Tuberculosis, Lima, Peru
Date of first enrolment: October 2012
Target sample size: 1900
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT02174380
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening  
Phase:  N/A
Countries of recruitment
Peru
Contacts
Name:     Lena Shah, MSc., PhD(c)
Address: 
Telephone:
Email:
Affiliation:  McGill University
Name:     Eduardo Gotuzzo, MD
Address: 
Telephone:
Email:
Affiliation:  Universidad Peruana Cayetano Heredia
Name:     Maximo Grados, MSc
Address: 
Telephone:
Email: maximo.grados@upch.pe
Affiliation: 
Name:     Timothy F Brewer, MD
Address: 
Telephone:
Email:
Affiliation:  University of California, Los Angeles
Name:     Lena Shah, MSc, PhD(c)
Address: 
Telephone: 514-357-4913
Email: lena.shah@mail.mcgill.ca
Affiliation: 
Name:     Jay S Kaufman, PhD
Address: 
Telephone:
Email:
Affiliation:  McGill University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Index TB cases will be included if they are =15 years old, sputum smear positive and
identify at least one household contact on questioning. All TB household contacts
identified will be included if they meet the program household contact definition and
have not previously been diagnosed or under current TB treatment.

Exclusion Criteria:

- Patients who are receiving treatment from private clinics, are in prison or otherwise
institutionalized, will be excluded from enrollment as index cases as per current
DISA NTP practice. TB cases reported outside of the Ministry of Health clinics will
not be included unless they are referred and enter the Ministry of Health system and
the DOTS program



Age minimum: 15 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Tuberculosis
Intervention(s)
Other: Active Household Contact Evaluation
Primary Outcome(s)
Active Tuberculosis [Time Frame: 6 months]
Secondary Outcome(s)
Secondary ID(s)
CIHR-235353
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
McGill University
Canadian Institutes of Health Research (CIHR)
Universidad Peruana Cayetano Heredia
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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