Developing Reporting Guidelines for Studies of HIV Drug Resistance Prevalence: Protocol of a Mixed-methods Study (Preprint)
BACKGROUND HIV drug resistance is a global health problem which limits the effectiveness of antiretroviral therapy (ART). Adequate surveillance of HIV drug resistance is challenged by heterogenous and inadequate data reporting, which compromises the accuracy, interpretation, and usability of prevalence estimates. Previous research has found that the quality of reporting in studies of HIV drug resistance prevalence is low, and thus better guidance is needed to ensure complete and uniform reporting. OBJECTIVE This paper aims to develop reporting guidelines for studies of HIV drug resistance by achieving consensus among experts on what items should be reported in these studies. METHODS We will conduct a sequential explanatory mixed methods study among authors and users of studies of HIV drug resistance. The two-phase design will include a cross-sectional electronic survey (quantitative phase) followed by a focus group discussion (qualitative phase). Survey participants will rate the essentiality of various reporting items, which will be analyzed in a validity ratio to determine the items that will be retained for further evaluation. Retained items will form a list of potential reporting items that will be reviewed in a focus group discussion informed by grounded theory to produce a finalized set of reporting items. RESULTS This study received ethics approval from the Hamilton Integrated Research Ethics Board (project number #11558) on November 11, 2020. As of March 2021, 46 participants provided informed consent and completed the electronic survey. In October 2021 nine of these participants participated in virtual focus group discussions. CONCLUSIONS This study will provide a reporting checklist for studies of HIV drug resistance by achieving consensus among experts on what items should be reported in these studies. The results of this work will be refined and elaborated on by a writing committee of HIV drug resistance experts and external reviewers to develop finalized reporting guidelines.