ABSTRACT
The patient information leaflet (PIL) is recognised as playing a key role in informing patients about their medicines. The objectives of this research were to evaluate the read- ability and understanding of a PIL for the first-line ARV (antiretroviral) regimen available in the South African public health sector; and investigate its acceptability in the target Xhosa population. The study took place between August 2003 and July 2004. A PIL was designed for the antiretroviral regimen of stavudine; lamivudine and efavirenz; using established usability guidelines. South African legal requirements concerning PILs were incorporated and the PILs were available in both eng and isiXhosa. Sixty Xhosa participants between the ages of 18 and 61 years old; with varied levels of education; ranging from no schooling to tertiary level education; were interviewed and demographic data were collected. All participants had stated that they could read. They were asked to read the PIL and a series of questions was asked to assess its comprehension and acceptability. The overall average rate of understanding was 80. Six of the 20 questions were located and understood by all participants; and only two questions resulted in less than an 85 correct response.The PIL was rated as difficult to read by only three participants. Physical appearance and quantity of information were highly rated and all partici- pants were enthusiastic about the inclusion of pictograms