Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial

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dc.contributor.authorJaffar, Shabbar
dc.contributor.authorAmuron, Barbara
dc.contributor.authorFoster, Susan
dc.contributor.authorBirungi, Josephine
dc.contributor.authorLevin, Jonathan
dc.contributor.authorNamara, Geoffrey
dc.contributor.authorNabiryo, Christine
dc.contributor.authorNdembi, Nicaise
dc.contributor.authorKyomuhangi, Rosette
dc.contributor.authorOpio, Alex
dc.contributor.authorBunnell, Rebecca
dc.contributor.authorTappero, Jordan W.
dc.contributor.authorMermin, Jonathan
dc.contributor.authorCoutinho, Alex
dc.contributor.authorGrosskurth, Heiner
dc.date.accessioned2018-07-26T10:36:07Z
dc.date.available2018-07-26T10:36:07Z
dc.date.issued2009-12-19
dc.descriptionIdentification of new ways to increase access to antiretroviral therapy in Africa is an urgent priority. We assessed whether home-based HIV care was as effective as was facility-based care.en_US
dc.description.abstractBackground: Identification of new ways to increase access to antiretroviral therapy in Africa is an urgent priority. We assessed whether home-based HIV care was as effective as was facility-based care. Methods: We undertook a cluster-randomised equivalence trial in Jinja, Uganda. 44 geographical areas in nine strata, defined according to ratio of urban and rural participants and distance from the clinic, were randomised to home-based or facility-based care by drawing sealed cards from a box. The trial was integrated into normal service delivery. All patients with WHO stage IV or late stage III disease or CD4-cell counts fewer than 200 cells per μL who started antiretroviral therapy between Feb 15, 2005, and Dec 19, 2006, were eligible, apart from those living on islands. Follow-up continued until Jan 31, 2009. The primary endpoint was virological failure, defined as RNA more than 500 copies per mL after 6 months of treatment. The margin of equivalence was 9% (equivalence limits 0•69–1•45). Analyses were by intention to treat and adjusted for baseline CD4-cell count and study stratum. This trial is registered at http://isrctn.org, number ISRCTN 17184129. Findings: 859 patients (22 clusters) were randomly assigned to home and 594 (22 clusters) to facility care. During the first year, 93 (11%) receiving home care and 66 (11%) receiving facility care died, 29 (3%) receiving home and 36 (6%) receiving facility care withdrew, and 8 (1%) receiving home and 9 (2%) receiving facility care were lost to follow-up. 117 of 729 (16%) in home care had virological failure versus 80 of 483 (17%) in facility care: rates per 100 person-years were 8•19 (95% CI 6•84–9•82) for home and 8•67 (6•96–10•79) for facility care (rate ratio [RR] 1•04, 0•78–1•40; equivalence shown). Two patients from each group were immediately lost to follow-up. Mortality rates were similar between groups (0•95 [0•71–1•28]). 97 of 857 (11%) patients in home and 75 of 592 (13%) in facility care were admitted at least once (0•91, 0•64–1•28). Interpretation: This home-based HIV-care strategy is as effective as is a clinic-based strategy, and therefore could enable improved and equitable access to HIV treatment, especially in areas with poor infrastructure and access to clinic care. Funding: US Centers for Disease Control and Prevention and UK Medical Research Council.en_US
dc.description.sponsorshipUS Centers for Disease Control and Prevention and UK Medical Research Council.en_US
dc.identifier.citationJaffar, Shabbar, Amuron, Barbara, Foster, Susan, Birungi, Josephine, Levin, Jonathan, Namara, Geoffrey, Nabiryo, Christine, Ndembi, Nicaise, Kyomuhangi, Rosette, Opio, Alex, Bunnell, Rebecca, Tappero,Jordan W., Mermin, Jonathan, Coutinho, Alex, Grosskurth Heiner, 2009.Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial.en_US
dc.identifier.urihttps://hdl.handle.net/20.500.11951/314
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.subjectVirologicalen_US
dc.subjectPatientsen_US
dc.subjectHome-Based HIV care modelen_US
dc.subjectFacility-based HIV care modelen_US
dc.subjectSoutheast Ugandaen_US
dc.titleRates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trialen_US
dc.typeArticleen_US
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The final, definitive version of this paper has been published in the Lancet, Volume 374, No.9707, 19 December/2009. DOI: https://doi.org/10.1016/S0140-6736(09)61674-3; published by Elsevier.
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