Abstract

Background Ensuring informed consent is a complicated component of clinical trials particularly with HIV prevention trials conducted in resource-limited settings. An inherent challenge of the informed consent process for HIV prevention studies is making sure trial participants understand that their participation does not increase exposure to HIV. Participants need to comprehend that partaking in such trials does not necessarily protect them from HIV. It is important to continuously monitor the informed consent process for clinical trials with view to improving the procedure.

Highlights

  • Ensuring informed consent is a complicated component of clinical trials with HIV prevention trials conducted in resource-limited settings

  • An inherent challenge of the informed consent process for HIV prevention studies is making sure trial participants understand that their participation does not increase exposure to HIV

  • An interview guide was used to elicit views around the informed consent process

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Summary

Introduction

Ensuring informed consent is a complicated component of clinical trials with HIV prevention trials conducted in resource-limited settings. An inherent challenge of the informed consent process for HIV prevention studies is making sure trial participants understand that their participation does not increase exposure to HIV. Participants need to comprehend that partaking in such trials does not necessarily protect them from HIV. It is important to continuously monitor the informed consent process for clinical trials with view to improving the procedure

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