The team conducted an environmental scan to explore the patient-reported outcome measures (PROMs) that could be used in new and emerging human immunodeficiency virus (HIV) therapies. In the context of HIV clinical trials, PROMs may be used as clinical outcome assessments (COAs) to characterize how patients feel and function and to inform regulatory evaluations. The emergence of long-acting antiretroviral therapies (LA-ARTs) introduces modality-specific considerations that may not be fully captured by PROMs used in traditional HIV trials. We conducted an environmental scan to identify PROMs used in traditional antiretroviral therapy (ART) and LA-ART trials. Activities included a peer-reviewed literature search using PubMed and Embase and a targeted scan of grey literature, with emphasis on sources documenting PROM use in trials (e.g., ClinicalTrials.gov) and selected HIV-focused advocacy organizations. The environmental scan identified extensive use of PROMs in HIV research and traditional ART trials, but a smaller subset of measures has been used in LA-ART trials. PROMs have been used broadly in HIV studies; however, many measures have limited psychometric evidence, and only a subset has been applied in LA-ART trials.
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