Abstract

BackgroundHealth care associated transmission of Mycobacterium tuberculosis (TB) is well described. A previous survey of infection control (IC) practices at clinical research sites in low and middle income countries (LMIC) funded by the National Institute of Allergy and Infectious Diseases (NIAID) conducting HIV research identified issues with respiratory IC practices. A guideline for TB IC based on international recommendations was developed and promulgated. This paper reports on adherence to the guideline at sites conducting or planning to conduct TB studies with the intention of supporting improvement.MethodsA survey was developed that assessed IC activities in three domains: facility level measures, administrative control measures and environmental measures. An external site monitor visited each site in 2013–2014, to complete the audit. A central review committee evaluated the site-level survey and results were tabulated. Fisher’s exact test was performed to determine whether there were significant differences in practices at sites that had IC officers versus sites that did not have IC officers. Significance was assessed at p</=.05ResultsSeven of thirty-three sites surveyed (22 %) had all the evaluated tuberculosis IC (TB IC) elements in place. Sixty-one percent of sites had an IC officer tasked with developing and maintaining TB IC standard operating procedures. Twenty-two (71 %) sites promptly identified and segregated individuals with TB symptoms. Thirty (93 %) sites had a separate waiting area for patients, and 26 (81 %) collected sputum within a specific well-ventilated area that was separate from the general waiting area. Sites with an IC officer were more likely to have standard operating procedures covering TB IC practices (p = 0.02) and monitor those policies (p = 0.02) and perform regular surveillance of healthcare workers (p = 0.02). The presence of an IC officer had a positive impact on performance in most of the TB IC domains surveyed including having adequate ventilation (p = 0.02) and a separate area for sputum collection (p = 0.02)ConclusionsSpecific and targeted support of TB IC activities in the clinical research environment is needed and is likely to have a positive and sustained impact on preventing the transmission of TB to both health care workers and vulnerable HIV-infected research participants.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-016-1579-y) contains supplementary material, which is available to authorized users.

Highlights

  • Health care associated transmission of Mycobacterium tuberculosis (TB) is well described

  • Thirty-three National Institute of Allergy and Infectious Diseases (NIAID)-funded clinical research sites located in low and middle income countries (LMIC) in the AIDS Clinical Trials Group (ACTG) and the International Maternal, Pediatric, Adolescent AIDS Clinical Trials Network (IMPAACT) networks signaled their intention to participate in clinical trials involving TB

  • In our study the presence of an infection control (IC) practitioner was more likely to be associated with the availability of basic elements of IC practice, this was less influential on overall TB specific IC practices than we expected

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Summary

Introduction

Health care associated transmission of Mycobacterium tuberculosis (TB) is well described. This paper reports on adherence to the guideline at sites conducting or planning to conduct TB studies with the intention of supporting improvement. The contribution of health care associated infections to patient morbidity may be underestimated and significant [4]. Health care associated transmission of Mycobacterium tuberculosis (TB) is well described in both patients and health care workers and outbreaks of tuberculosis including extensively drug resistant TB (XDR TB) have been linked to the health care environment in several resource limited settings [5, 6]. Prevention of health care associated TB transmission, is an urgent IC need in resource-limited settings. This paper reports on uptake of these recommendations at clinical sites conducting or planning to conduct TBrelated ACTG clinical trials with the objective of improving participant and staff safety

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