Impact of alcohol consumption on tuberculosis treatment outcomes : a prospective longitudinal cohort study protocol

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dc.contributor.authorMyers, Bronwynen_ZA
dc.contributor.authorBouton, Tara C.en_ZA
dc.contributor.authorRagan, Elizabeth J.en_ZA
dc.contributor.authorWhite, Laura F.en_ZA
dc.contributor.authorMcIlleron, Helenen_ZA
dc.contributor.authorTheron, Danieen_ZA
dc.contributor.authorParry, Charles D. H.en_ZA
dc.contributor.authorHorsburgh, C. R.en_ZA
dc.contributor.authorWarren, Robin M.en_ZA
dc.contributor.authorJacobson, Karen R.en_ZA
dc.date.accessioned2018-10-01T05:37:46Z
dc.date.available2018-10-01T05:37:46Z
dc.date.issued2018-09-29
dc.date.updated2018-09-30T03:55:07Z
dc.descriptionCITATION: Myers, B. et al. 2018. Impact of alcohol consumption on tuberculosis treatment outcomes : a prospective longitudinal cohort study protocol. BMC Infectious Diseases, 18:488, doi:10.1186/s12879-018-3396-y.
dc.descriptionThe original publication is available at https://bmcinfectdis.biomedcentral.com
dc.description.abstractBackground: An estimated 10% of tuberculosis (TB) deaths are attributable to problematic alcohol use globally, however the causal pathways through which problem alcohol use has an impact on TB treatment outcome is not clear. This study aims to improve understanding of these mechanisms. Specifically, we aim to 1) assess whether poor TB treatment outcomes, measured as delayed time-to-culture conversion, are associated with problem alcohol use after controlling for non-adherence to TB pharmacotherapy; and 2) to determine whether pharmacokinetic (PK) changes in those with problem alcohol use are associated with delayed culture conversion, higher treatment failure/relapse rates or with increased toxicity. Methods: Our longitudinal, repeated measures, prospective cohort study aims to examine the associations between problem alcohol use and TB treatment outcomes and to evaluate the effect of alcohol on the PK and pharmacodynamics (PD) of TB drugs. We will recruit 438 microbiologically confirmed, pulmonary TB patients with evidence of rifampicin susceptibility in Worcester, South Africa with 200 HIV uninfected patients co-enrolled in the PK aim. Participants are followed for the six months of TB treatment and an additional 12 months thereafter, with sputum collected weekly for the first 12 weeks of treatment, alcohol consumption measures repeated monthly in concert with an alcohol biomarker (phosphatidylethanol) measurement at baseline, and in person directly observed therapy (DOT) using real-time mobile phone-based adherence monitoring. The primary outcome is based on time to culture conversion with the second objective to compare PK of first line TB therapy in those with and without problem alcohol use. Discussion: Globally, an urgent need exists to identify modifiable drivers of poor TB treatment outcomes. There is a critical need for more effective TB treatment strategies for patients with a history of problem alcohol use. However, it is not known whether poor treatment outcomes in alcohol using patients are solely attributable to noncompliance. This study will attempt to answer this question and provide guidance for future TB intervention trials. Trial registration: Clinicaltrials.gov, Registration Number: NCT02840877. Registered on 19 July 2016.en_ZA
dc.description.sponsorshipUnited States National Institute of Allergy and Infectious Diseases (FAIN: R01AI119037)
dc.description.sponsorshipNational Institutes of Health (T32, DA013911)
dc.description.urihttps://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-018-3396-y
dc.description.versionPublisher's version
dc.format.extent9 pagesen_ZA
dc.identifier.citationMyers, B. et al. 2018. Impact of alcohol consumption on tuberculosis treatment outcomes : a prospective longitudinal cohort study protocol. BMC Infectious Diseases, 18:488, doi:10.1186/s12879-018-3396-y.
dc.identifier.issn1471-2334 (online)
dc.identifier.otherdoi:10.1186/s12879-018-3396-y
dc.identifier.urihttp://hdl.handle.net/10019.1/104539
dc.language.isoen_ZAen_ZA
dc.publisherBioMed Centralen_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectTuberculosisen_ZA
dc.subjectTuberculosis -- Treatmenten_ZA
dc.subjectPatient complianceen_ZA
dc.subjectPharmacokineticsen_ZA
dc.subjectDrinking alcoholen_ZA
dc.subjectMycobacterium tuberculosisen_ZA
dc.subjectTuberculosis -- Patients -- Drinking alcoholen_ZA
dc.titleImpact of alcohol consumption on tuberculosis treatment outcomes : a prospective longitudinal cohort study protocolen_ZA
dc.typeArticle
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