COSTOP was a randomised controlled trial designed to assess the risks and benefits to HIV-infected participants stabilised on anti-retroviral treatment of stopping cotrimoxazole (CTX). In order to assess the extent to which patients may have had access to and used CTX other than that supplied as study drug it was decided to conduct an exit interview.
A structured interview was administered by interviewers who were not associated with the COSTOP trial team in order to make it easier for participants to respond truthfully to sensitive questions about adherence to the study protocol.
A total of 1993 participants were interviewed. Only 29 (1.7%) said they had taken their left over CTX; 101 (6.1%) had kept supplies at home. When asked about obtaining open label CTX during the trial 92 (4.7%) participants said they had done so, in contrast to only 12 who admitted doing so when asked at trial visits. The questions participants found most difficult to answer honestly at clinic visits were those concerning adherence to trial drugs (15.6% of participants) and whether they had slept under the insecticide treated mosquito nets (14.9%).
The exit interview demonstrated that there was some evidence of open label drug being taken by the participants. However, the results from the interview do not suggest that the trial results would have been seriously compromised. We would recommend the exit interview as a valuable way of assessing adherence to trial procedures.