Development of written information for antiretroviral therapy: comprehension in a Tanzanian population

Objective To design and develop a simple, easily readable patient information leaflet (PIL) for a commonly used antiretroviral (ARV) regimen and to evaluate its readability and acceptability in a Tanzanian population. Method A PIL incorporating simple text and pictograms was designed for the antiretroviral regimen of stavudine, lamivudine and efavirenz. The PIL was designed according to established good design guidelines, modified during a multi-stage iterative testing process and piloted in a South African Xhosa population. The PIL was made available in both English and Kiswahili. Sixty Tanzanian participants who were not taking ARVs were interviewed. They were asked to read the PIL in the language of their choice and were then asked a series of two-part questions; the first part required participants to locate the information in the PIL, after which they were asked to explain the information in their own words. Acceptability was assessed through close-ended questions and open-ended feedback. The influence of selected patient characteristics on comprehension of the PIL was investigated using one-way ANOVA and t-tests for independent samples with a significance level set at 0.05. Main outcome measure Comprehension of the written information in an overall percentage understanding. Results The overall average percentage comprehension of the PIL was 95%. The target set by the EC guideline that at least 80% of participants correctly locate and understand the information was achieved for 19 of the 20 questions. Five of the six instructions illustrated by pictograms were correctly understood by all participants. The only patient characteristics significantly associated with comprehension were educational level and self-reported ease of reading the PIL. Acceptability of the PIL was high and positive comments were associated with simplicity, good design, easy readability and user-friendliness, the latter enhanced by the inclusion of pictograms. Conclusion The PIL designed for this study was shown to be effective in communicating information about ARVs. Patient characteristics must be taken into account when developing written information, and the final document must be tested for comprehension in the target population.