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dc.contributor.authorBassett, Ingrid Ven_US
dc.contributor.authorGiddy, Janeten_US
dc.contributor.authorChaisson, Christine Een_US
dc.contributor.authorRoss, Douglasen_US
dc.contributor.authorBogart, Laura Men_US
dc.contributor.authorColeman, Sharon Men_US
dc.contributor.authorGovender, Tessaen_US
dc.contributor.authorRobine, Marionen_US
dc.contributor.authorErlwanger, Alisonen_US
dc.contributor.authorFreedberg, Kenneth Aen_US
dc.contributor.authorKatz, Jeffrey Nen_US
dc.contributor.authorWalensky, Rochelle Pen_US
dc.contributor.authorLosina, Elenaen_US
dc.date.accessioned2014-03-10T16:16:17Z
dc.date.issued2013en_US
dc.identifier.citationBassett, I. V., J. Giddy, C. E. Chaisson, D. Ross, L. M. Bogart, S. M. Coleman, T. Govender, et al. 2013. “A randomized trial to optimize HIV/TB care in South Africa: design of the Sizanani trial.” BMC Infectious Diseases 13 (1): 390. doi:10.1186/1471-2334-13-390. http://dx.doi.org/10.1186/1471-2334-13-390.en
dc.identifier.issn1471-2334en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:11876995
dc.description.abstractBackground: Despite increases in HIV testing, only a fraction of people newly diagnosed with HIV infection enter the care system and initiate antiretroviral therapy (ART) in South Africa. We report on the design and initial enrollment of a randomized trial of a health system navigator intervention to improve linkage to HIV care and TB treatment completion in Durban, South Africa. Methods/Design We employed a multi-site randomized controlled trial design. Patients at 4 outpatient sites were enrolled prior to HIV testing. For all HIV-infected participants, routine TB screening with sputum for mycobacterial smear and culture were collected. HIV-infected participants were randomized to receive the health system navigator intervention or usual care. Participants in the navigator arm underwent a baseline interview using a strengths-based case management approach to assist in identifying barriers to entering care and devising solutions to best cope with perceived barriers. Over 4 months, participants in the navigator arm received scheduled phone and text messages. The primary outcome of the study is linkage and retention in care, assessed 9 months after enrollment. For ART-eligible participants without TB, the primary outcome is 3 months on ART as documented in the medical record; participants co-infected with TB are also eligible to meet the primary outcome of completion of 6 months of TB treatment, as documented by the TB clinic. Secondary outcomes include mortality, receipt of CD4 count and TB test results, and repeat CD4 counts for those not ART-eligible at baseline. We hypothesize that a health system navigator can help identify and positively affect modifiable patient factors, including self-efficacy and social support, that in turn can improve linkage to and retention in HIV and TB care. Discussion We are currently evaluating the clinical impact of a novel health system navigator intervention to promote entry to and retention in HIV and TB care for people newly diagnosed with HIV. The details of this study protocol will inform clinicians, investigators, and policy makers of strategies to best support HIV-infected patients in resource-limited settings. Trial registration Clinicaltrials.gov. unique identifier: NCT01188941.en
dc.language.isoen_USen
dc.publisherBioMed Centralen
dc.relation.isversionofdoi:10.1186/1471-2334-13-390en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3765953/pdf/en
dash.licenseLAAen_US
dc.subject(3-10): HIV/AIDSen
dc.subjectTuberculosisen
dc.subjectSouth Africaen
dc.subjectLinkage to careen
dc.subjectSMS remindersen
dc.subjectRandomized controlled trialen
dc.subjectCounseling/Supporten
dc.titleA randomized trial to optimize HIV/TB care in South Africa: design of the Sizanani trialen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalBMC Infectious Diseasesen
dash.depositing.authorBassett, Ingrid Ven_US
dc.date.available2014-03-10T16:16:17Z
dc.identifier.doi10.1186/1471-2334-13-390*
dash.authorsorderedfalse
dash.contributor.affiliatedBogart, Laura M.
dash.contributor.affiliatedBassett, Ingrid
dash.contributor.affiliatedFreedberg, Kenneth
dash.contributor.affiliatedLosina, Elena
dash.contributor.affiliatedWalensky, Rochelle
dash.contributor.affiliatedKatz, Jeffrey


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