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

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 10 6 cells/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.