ABSTRACT
INTRODUCTION: The research literature addressing pre-exposure prophylaxis (PrEP) has increased considerably over the last decade. To better understand the research areas and explore research gaps, we will conduct a scoping review to map study topics and describe study characteristics and populations in publications focused on PrEP. The purpose of this protocol is to describe planned methods for the scoping review. METHODS AND ANALYSIS: We will implement a comprehensive systematic literature search to identify PrEP citations in the United States Centres for Disease Control and Prevention HIV/AIDS Prevention Research Synthesis Project database that is unique and extensively focuses on HIV/sexually transmitted infections/hepatitis. We will screen and include studies that are (1) focused on HIV PrEP, (2) primary research with human participants and (3) published in English. Two reviewers will independently abstract data on authors' names, study years, countries, population characteristics and design. To describe and summarise study topics, we will use 19 codes and five categories that were developed from a preliminary study. The five categories are category 1: potential PrEP user/prescriber (behaviours/issues for potential PrEP takers/healthcare professionals), category 2: considerations while on PrEP (experiences of and problems related to staying on or prescribing PrEP), category 3: PrEP efficacy and safety (biomedical aspects and medication efficacy), category 4: methods of and experiences with PrEP clinical trials (possesses/experiences of clinical trials) and category 5: cost-effectiveness or economic evaluation (cost studies). Data will be analysed with descriptive statistics. ETHICS AND DISSEMINATION: The findings will be presented at HIV-related conferences and published in peer-review journals.