Cargando…

Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial

BACKGROUND: Tuberculosis is an infectious disease that continues to cause considerable morbidity and mortality globally. Only 65% of patients worldwide are currently diagnosed. Contact investigation is a strategy that aims to increase case detection and reduce transmission of tuberculosis, yet there...

Descripción completa

Detalles Bibliográficos
Autores principales: Fox, Gregory J, Nhung, Nguyen Viet, Sy, Dinh Ngoc, Britton, Warwick J, Marks, Guy B
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4015151/
https://www.ncbi.nlm.nih.gov/pubmed/24138766
http://dx.doi.org/10.1186/1745-6215-14-342
_version_ 1782315288827527168
author Fox, Gregory J
Nhung, Nguyen Viet
Sy, Dinh Ngoc
Britton, Warwick J
Marks, Guy B
author_facet Fox, Gregory J
Nhung, Nguyen Viet
Sy, Dinh Ngoc
Britton, Warwick J
Marks, Guy B
author_sort Fox, Gregory J
collection PubMed
description BACKGROUND: Tuberculosis is an infectious disease that continues to cause considerable morbidity and mortality globally. Only 65% of patients worldwide are currently diagnosed. Contact investigation is a strategy that aims to increase case detection and reduce transmission of tuberculosis, yet there is little evidence to show its effectiveness. METHODS/DESIGN: We will conduct a cluster randomized controlled trial of contact investigation within the national tuberculosis control program of Vietnam. Household contacts of patients with smear-positive pulmonary tuberculosis will be invited to attend district tuberculosis units for symptom screening, examination, and chest radiography on four occasions over a two-year period. The primary endpoint is clinically confirmed tuberculosis among contacts during the 24 months of follow-up, ascertained using capture-recapture analysis. Microbiologically proven tuberculosis and treatment completion rates among contacts diagnosed with tuberculosis will be secondary endpoints. The incremental cost-effectiveness ratio will be estimated. The study will have 80% power to detect a 50% increase in the primary endpoint in the active intervention arm compared with the control arm. The study will include 8,829 contacts in each of the active screening and control groups, within 70 districts in 8 provinces in Vietnam, in both rural and urban settings. DISCUSSION: The effectiveness of contact investigation as a tool for improved tuberculosis case finding has not been established. This cluster randomized trial will provide valuable operational information for national tuberculosis programs in high-prevalence countries, in order to select the most cost-effective strategies to improve tuberculosis case detection. TRIAL REGISTRATION: The ACT2 study has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12610000600044).
format Online
Article
Text
id pubmed-4015151
institution National Center for Biotechnology Information
language English
publishDate 2013
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-40151512014-05-10 Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial Fox, Gregory J Nhung, Nguyen Viet Sy, Dinh Ngoc Britton, Warwick J Marks, Guy B Trials Study Protocol BACKGROUND: Tuberculosis is an infectious disease that continues to cause considerable morbidity and mortality globally. Only 65% of patients worldwide are currently diagnosed. Contact investigation is a strategy that aims to increase case detection and reduce transmission of tuberculosis, yet there is little evidence to show its effectiveness. METHODS/DESIGN: We will conduct a cluster randomized controlled trial of contact investigation within the national tuberculosis control program of Vietnam. Household contacts of patients with smear-positive pulmonary tuberculosis will be invited to attend district tuberculosis units for symptom screening, examination, and chest radiography on four occasions over a two-year period. The primary endpoint is clinically confirmed tuberculosis among contacts during the 24 months of follow-up, ascertained using capture-recapture analysis. Microbiologically proven tuberculosis and treatment completion rates among contacts diagnosed with tuberculosis will be secondary endpoints. The incremental cost-effectiveness ratio will be estimated. The study will have 80% power to detect a 50% increase in the primary endpoint in the active intervention arm compared with the control arm. The study will include 8,829 contacts in each of the active screening and control groups, within 70 districts in 8 provinces in Vietnam, in both rural and urban settings. DISCUSSION: The effectiveness of contact investigation as a tool for improved tuberculosis case finding has not been established. This cluster randomized trial will provide valuable operational information for national tuberculosis programs in high-prevalence countries, in order to select the most cost-effective strategies to improve tuberculosis case detection. TRIAL REGISTRATION: The ACT2 study has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12610000600044). BioMed Central 2013-10-20 /pmc/articles/PMC4015151/ /pubmed/24138766 http://dx.doi.org/10.1186/1745-6215-14-342 Text en Copyright © 2013 Fox et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Fox, Gregory J
Nhung, Nguyen Viet
Sy, Dinh Ngoc
Britton, Warwick J
Marks, Guy B
Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial
title Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial
title_full Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial
title_fullStr Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial
title_full_unstemmed Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial
title_short Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial
title_sort household contact investigation for tuberculosis in vietnam: study protocol for a cluster randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4015151/
https://www.ncbi.nlm.nih.gov/pubmed/24138766
http://dx.doi.org/10.1186/1745-6215-14-342
work_keys_str_mv AT foxgregoryj householdcontactinvestigationfortuberculosisinvietnamstudyprotocolforaclusterrandomizedcontrolledtrial
AT nhungnguyenviet householdcontactinvestigationfortuberculosisinvietnamstudyprotocolforaclusterrandomizedcontrolledtrial
AT sydinhngoc householdcontactinvestigationfortuberculosisinvietnamstudyprotocolforaclusterrandomizedcontrolledtrial
AT brittonwarwickj householdcontactinvestigationfortuberculosisinvietnamstudyprotocolforaclusterrandomizedcontrolledtrial
AT marksguyb householdcontactinvestigationfortuberculosisinvietnamstudyprotocolforaclusterrandomizedcontrolledtrial