Cognitive screening considerations for psychosocial clinical trials in HIV, aging, and cognition

Abstract

Cognitive impairment is a common comorbidity among individuals aging with HIV, which can be an extreme source of stress and anxiety for many. Psychosocial interventions have the potential to alleviate symptoms associated with cognitive impairment and help improve the quality of life of people with HIV as they continue to age; these interventions are in the infancy of development and require further testing via clinical trials. The slow development of interventions may be partially attributed to a common trend of requiring a formal HIV-associated neurocognitive disorder diagnosis to qualify for psychosocial clinical trials. HIV-associated neurocognitive disorder is diagnosed through intensive, time-consuming tests, and still many cases of HIV-associated neurocognitive disorder remain undiagnosed, misdiagnosed, or misclassified due to the limitations of the assessment process. This commentary suggests an alternate method of screening for cognitive impairments through the use of a brief, low-barrier assessment, alongside validity considerations. Such alternate screening may improve enrollment and completion rates in psychosocial clinical trials for people aging with HIV and cognitive impairment, by removing the burden of extensive testing that is commonly associated with an HIV-associated neurocognitive disorder diagnosis from clinical trial eligibility, while still providing valuable insight into individuals’ cognitive functioning.

Adapting Cognitive Remediation Group Therapy as an Online or Hybrid Intervention for People Aging With HIV and Cognitive Concerns: Focus Group Protocol

“…Based on our team’s experience piloting the in-person CRGT RCT and our combined years of research and practice, we have identified that a clinical diagnosis of HIV-associated neurocognitive disorder (HAND) may be a barrier to participation in CRGT. As such, a brief screen of cognition may be a more suitable entry condition with the option of referral to HAND testing upon completion of the intervention (Eaton et al, in press). Exploring the receptivity of this proposed process by people aging with HIV and cognitive concerns in focus groups will be important to determining a suitable, community-driven study design for the efficacy RCT.…”

“…However, the small sample size ( n = 12) limited the conclusions we could draw from the pilot. It was predominantly due to participants being required to have a formal HAND diagnosis, which is difficult to conclude (Eaton et al, in press; Ramirez-Garcia et al, 2019). That, by itself, limited our sampling frame to 40 individuals.…”

Adapting cognitive remediation group therapy: A community-based, focus group study

“…Each of these strategies have been individually found helpful amongst people living with HIV [24,25] Results showed that CRGT performed better or equal to mutual aid on outcomes of feasibility, acceptability, fidelity, stress, anxiety, and coping [20,21]. However, the pilot small sample size (n=12) -which was chiefly due to the requirement that participants be formally diagnosed with HAND, a condition that is difficult to determine [26]-limited the conclusions that could be drawn from the results, encouraged consideration of alternative cognitive screens, and necessitated a sufficiently powered trial to determine efficacy. Moreover, the onset of the COVID-19 pandemic ceased all in-person group therapy at the time; and since then, psychosocial interventions are increasingly being adapted as online or hybrid initiatives, and these shifts in healthcare delivery formats appear to be persisting [27,28].…”

Adapting Cognitive Remediation Group Therapy Online: Focus Groups with People Aging with HIV

“… 23 , 24 However, the pilot utilized a small sample size ( n =12), which was chiefly due to the requirement that participants be formally diagnosed with HAND, a condition that is difficult to determine. 29 The small sample limited the conclusions that could be drawn from the results and encouraged consideration of alternative screening measure for cognition. Consequently, a sufficiently powered trial was needed after the pilot to determine intervention efficacy.…”