Exploring research participants’ perceptions and comprehension of the informed consent process in a pre-exposure HIV prevention study: a case study

Abstract

Background: Ensuring informed consent is a complicated component of research, particularly with HIV prevention research conducted in poor settings. An inherent challenge characteristic of the informed consent process for HIV prevention studies is making sure that subjects understand that participation does not increase exposure to HIV and does not necessarily protect them from HIV. It is important to continuously monitor the informed consent process. Methods: In June- September, 2011, gender-specific in-depth interviews (n=20) were held with interviewees who had been purposively selected from participants who had exited a vaginal HIV prevention study in Harare, Zimbabwe. An interview guide was used to elicit views around the informed consent process. Discussions were conducted in mother tongue and audio-recorded. Audio-recorded data were transcribed, translated verbatim into English, coded using NVivo 8 and analysed using grounded theory principles. Results: Key information about study was given, as subjects articulated study aims well. However, it appeared that the informed consent process had been rushed and some participants had not had enough time to decide. Moreover, some participants reported that due to both excitement and anxiety, they had felt pressured to sign consent forms before comprehending some aspects of the study. Some mentioned that they had found it difficult to ask questions about the study. Both the study procedure and duration had not been fully explained. There were mixed feelings on importance of male partner involvement in decision-making around study participation, with some feeling that spouses should have been involved and others stating that partner consultation did not matter. Conclusion: This study elicited some of the issues that characterise the informed consent process for clinical trials conducted in poor settings. It also highlighted the need for researchers' ingenuity in order to come up with strategies that tailor the informed process to suit the specific needs and circumstances of individual participants.