Exploring research participant's perceptions and comprehension of the informed consent process in a pre-exposure HIV prevention study in Zimbabwe : a case study.
Background. An inherent challenge in HIV prevention studies is making sure that trial participants understand the information. This study explored trial participants’ perceptions and comprehension of the informed consent process in a pre-exposure HIV prevention study. Method. Face-to-face in-depth interviews, using a study guide, were held with twenty interviewees purposively selected from ex-participants of an HIV prevention study. Audio-recorded data were transcribed, translated, coded using NVivo 8, and analysed according to themes. Results. The participants were all women between the ages of 18 and 40. Participants felt that key information had been given during the informed consent process. Most felt that the process of obtaining informed consent was rushed with some participants citing a need for more time to make a decision regarding participation. Some participants felt pressured to sign consent forms. Some found it difficult to ask questions and mixed feelings existed on male partner involvement in the decision-making process. Conclusions: Participants experienced the consent process as rushed and most only fully comprehended study concepts with time. Their concerns necessitate the reassessment of informed consent processes in a developing world setting.