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

MRC/UVRI Uganda Research Unit on AIDS, c/o Medical Research Council/ Uganda Virus Research Institute, P.O. Box 49, Entebbe, Uganda.
The Open AIDS Journal 02/2007; 1(1):21-7. DOI: 10.2174/1874613600701010021
Source: PubMed


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.

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Available from: Barbara Amuron, Jan 27, 2014
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    • "With the advent of ART and the emphasis on treatment adherence, many community and lay carers have taken on tasks that were previously the role of formal carers such as tracing non-adherent patients, providing HIV testing and counselling as well as other services (Rohleder and Swartz 2005, Schneider et al. 2008, Sanjana et al. 2009). More formal strategies of 'task-shifting' in HIV care Á involving the delegation of prevention, care and support activities to lower-level cadres (WHO and GHWA 2010) Á have been explored, with some studies suggesting that lay caregivers may be involved in the initiation of ART beyond their role as treatment supporters and that often, lower-level cadres provide equal or better quality of care compared to more qualified health workers (Amuron et al. 2007, Hermann et al. 2009, Callaghan et al. 2010). "
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    • "In this context, there are legitimate policy concerns about the impacts of HIV-related disease on women. However, many recent studies in Uganda as well as other parts of SSA have consistently shown that although women remain more vulnerable to HIV infection, once infected, men tend to be disadvantaged in terms of access to treatment and care [4–11]. "
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    • "All adult patients (18 years old or more) living within the TASO catchment population and initiating on ART were invited to join and enrolled consecutively. The trial was integrated into normal health service delivery [5-7]. Trial participants were managed identically to non-trial patients by TASO staff using national guidelines. "
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