RESEARCH ARTICLE


A Cluster-Randomised Trial to Compare Home-Based with Health Facility-Based Antiretroviral Treatment in Uganda: Study Design and Baseline Findings



Barbara Amuron1, Alex Coutinho2, Heiner Grosskurth1, 3, Christine Nabiryo2, Josephine Birungi2, Geoffrey Namara1, Jonathan Levin1, Peter G. Smith3, Shabbar Jaffar3 , *
1 MRC/UVRI Uganda Research Unit on AIDS, c/o Medical Research Council (MRC UK) / Uganda Virus Research Institute (UVRI) P.O. Box 49, Entebbe, Uganda
2 The AIDS Support Organisation, Old Mulago Complex, PO Box 10443, Kampala, Uganda
3 Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK


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2007 Bentham Science Publishers Ltd.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.5/), which permits unrestrictive use, distribution, and reproduction in any medium, provided the original work is properly cited.

* Address correspondence to this author at the London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK; Tel: 020 7927 2418; E-mail: shabbar.jaffar@lshtm.ac.uk


Abstract

The scale-up of antiretroviral therapy is progressing rapidly in Africa but with a limited evidence-base. We report the baseline results from a large pragmatic cluster-randomised trial comparing different strategies of ART delivery. The trial is integrated in normal health service delivery. 1453 subjects were recruited into the study. Significantly more women (71%) than men (29%) were recruited. The WHO HIV clinical stage at presentation did not differ significantly between men and women: 58% and 53% respectively were at WHO stage III or IV (p=0.9). Median CD4 counts (IQR) x 106cells/l were 98 (28, 160) among men and 111 (36, 166) among women. Sixty-four percent of women and 61% men had plasma viral load ≥100,000 copies. Baseline characteristics did not change over time. Considerably fewer men than women presented for treatment. Both men and women presented at an advanced stage with very low median CD4 count and high plasma viral load.

Keywords: Cluster-randomised trial, antiretroviral therapy, effectiveness trial, Africa, Home-based HIV care, baseline characteristics, equity..