Anxiety Symptom Ratings Before and During the Interruption of Antiretroviral Therapy as Part of HIV Cure-related Studies.

Background: An analytical treatment interruption (ATI) is a critical component of HIV cure research, allowing researchers to assess potential strategies aimed at durable antiretroviral treatment-free viral control. However, pausing antiretroviral treatment during an ATI may lead to uncertainty and psychological distress. Limited empirical data exist on the mental health impact of an ATI, specifically anxiety symptoms.

Methods: We conducted a longitudinal study to assess self-reported anxiety levels before and during an ATI in two HIV cure-related research studies at the University of California, San Francisco. Study 1 was an observational ATI study (NCT04359186), whereas study 2 was an interventional HIV cure trial (NCT04357821). Anxiety was measured at multiple time points using the Generalized Anxiety Disorder-7 and the State-Trait Anxiety Inventory. We analyzed changes in anxiety scores over time using interrupted time-series models.

Results: In study 1, anxiety was elevated at baseline and gradually declined over time but remained within the mild severity range. In study 2, anxiety increased significantly from before the ATI and during ATI, with higher peak anxiety levels compared with study 1. Anxiety was highly prevalent in both studies and increased during the ATI in study 2.

Conclusions: The uncertainty with an ATI may contribute to increased mild anxiety. However, this uncertainty can be measured and with resources, easily addressed to reduce risks for psychological harm.