NCT02174380

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

2.2 years

First QC Date

June 23, 2014

Last Update Submit

July 7, 2014

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Active Tuberculosis

    Evaluation of active Tuberculosis in exposed household contacts of TB patients enrolled in treatment

    6 months

Study Arms (2)

Passive Household Contact Evaluation

NO INTERVENTION

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

Active Household Contact Evaluation

EXPERIMENTAL

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

Interventions

Active Household Contact EvaluationOTHER

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.

Active Household Contact Evaluation

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Tropicales "Alexander von Humboldt", Universidad Peruana Cayetano Heredia

San Martín de Porres, Lima region, Ing. 42, Peru

RECRUITING

Related Publications (1)

  • Shah L, Rojas M, Mori O, Zamudio C, Kaufman JS, Otero L, Gotuzzo E, Seas C, Brewer TF. Implementation of a stepped-wedge cluster randomized design in routine public health practice: design and application for a tuberculosis (TB) household contact study in a high burden area of Lima, Peru. BMC Public Health. 2015 Jun 26;15:587. doi: 10.1186/s12889-015-1883-2.

    PMID: 26109173DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Shah, MSc, PhD(c)

CONTACT

514-357-4913lena.shah@mail.mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 25, 2014

Study Start

October 1, 2012

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

PE(1)