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Effectiveness of Active Case Finding of Household Contacts in a Routine Tuberculosis (TB) Control Program

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ClinicalTrials.gov Identifier: NCT02174380
Recruitment Status : Unknown
Verified July 2014 by Lena Shah, McGill University.
Recruitment status was:  Recruiting
First Posted : June 25, 2014
Last Update Posted : July 9, 2014
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McGill University
Universidad Peruana Cayetano Heredia
Information provided by (Responsible Party):
Lena Shah, McGill University

Brief Summary:
The purpose of this study is to determine the effectiveness and cost-effectiveness of a new population-based active case-finding program among adult household contacts of new infectious TB cases to detect active TB cases in the largest district, Lima, Peru.

Condition or disease Intervention/treatment Phase
Tuberculosis Other: Active Household Contact Evaluation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Cost-effectiveness of a Population-based Active TB Control Program for Tuberculosis, Lima, Peru
Study Start Date : October 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
No Intervention: Passive Household Contact Evaluation
Passive case finding refers to the current National TB program of voluntary self-reporting of symptomatic patients to the health system for diagnosis of TB and initiation of effective chemotherapy
Experimental: Active Household Contact Evaluation
The intervention program includes households visits of all newly diagnosed TB cases enrolled in TB treatment within a DISA NTP clinic in SJL district. During the home visit health staff will evaluate all household contacts for symptoms of active TB. Any person reporting cough for >14 days will be asked to provide a spot sputum for microscopy and referred to the clinic for chest x-ray and clinical evaluation. All household contacts ≤19 years will be referred to the clinic for chest x-ray, pediatric clinical evaluation and initiation of treatment for active or latent TB as required. Counseling including TB infection control practices and importance of diagnosis and treatment completion for TB cases will be provided to household members.
Other: Active Household Contact Evaluation
Active evaluation of TB household contacts will be introducted as a new intervention in the district. The intervention will be undertaken by routine public health staff under routine conditions, however the assignment, training, monitoring and supervision of this intervention will occur in a stepped wedge roll out.




Primary Outcome Measures :
  1. Active Tuberculosis [ Time Frame: 6 months ]
    Evaluation of active Tuberculosis in exposed household contacts of TB patients enrolled in treatment



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174380


Contacts
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Contact: Lena Shah, MSc, PhD(c) 514-357-4913 lena.shah@mail.mcgill.ca

Locations
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Peru
Instituto de Medicina Tropicales "Alexander von Humboldt", Universidad Peruana Cayetano Heredia Recruiting
San Martin de Porres, Lima, Peru, Ing. 42
Contact: Maximo Grados, MSc       maximo.grados@upch.pe   
Principal Investigator: Lena Shah, MSc., PhD(c)         
Principal Investigator: Eduardo Gotuzzo, MD         
Sponsors and Collaborators
Lena Shah
Canadian Institutes of Health Research (CIHR)
McGill University
Universidad Peruana Cayetano Heredia
Investigators
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Principal Investigator: Jay S Kaufman, PhD McGill University
Principal Investigator: Timothy F Brewer, MD University of California, Los Angeles
Principal Investigator: Lena Shah, MSc., PhD(c) McGill University
Principal Investigator: Eduardo Gotuzzo, MD Universidad Peruana Cayetano Heredia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lena Shah, Doctoral Student, McGill University
ClinicalTrials.gov Identifier: NCT02174380     History of Changes
Other Study ID Numbers: CIHR-235353
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections