62 - Decisional Capacity for Research Consent Among Youth Living with HIV: Findings from the UBACC

Background: Youth are especially vulnerable to HIV, as 22% of new HIV infections occur in youth between the ages of 13-24. While many people living with HIV are introduced to high-quality medical care though participation in clinical trials, conducting research with youth living with HIV (YLWH) presents ethical dilemmas involving consent/assent and how to best balance autonomy and protection. Decisional capacity (DC) to consent/assent (i.e., the understanding, appreciation, reasoning, and ability to express a choice) to clinical research gains significance in the context of balancing autonomy rights with the need to protect young research participants including YLWH. Given the vulnerability of YLWH, strategies to improve DC to assent/consent are warranted.
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Methods: As part of a randomized controlled pilot study that explored the feasibility and acceptability of a multimedia intervention designed to improve the decisional capacity of YLWH to consent/assent to HIV research (results reported elsewhere), we administered the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC; Jeste et al., 2007) to 30 youth aged 13-24 living with HIV (15 in intervention condition, 15 in control condition). UBACC interviews were recorded and transcribed, and items were scored 0-2 points using criteria established by authors. A predetermined cutoff score was used to determine decisional capacity. Descriptive statistics were used to analyze participant demographics. Differences in UBACC scores between the intervention and control group were analyzed using the Mann-Whitney U test for independent samples. Thematic analysis was used to analyze qualitative data from the UBACC interviews.

Results: Participants were predominantly Black (63.3%), non-Hispanic (60.0%), males (73.3%) aged 13-24 (M = 19.5, SD = 3.3). There was a significant difference in total UBACC scores between the intervention and control groups (U = 161.0, p = .045, r = .37), with youth in the intervention group scoring significantly higher than youth in the control group. An analysis of individual items revealed a difference between groups, U = 169.5, p = .02, r = .48 on one item (Please describe some of the risks or discomforts that people may experience if they participate in this study) with youth in the intervention group scoring significantly higher than youth in the control group. Despite significant differences between groups, neither group met the pre-established cutoff score for DC. Qualitative analyses provided data on the types of errors contributing to scores of 0 (no credit) and 1 (partial credit) across conditions. Common errors were related to understanding the study’s purpose, requirements, risks, and benefits.

Limitations: The use of a small sample size from a restricted geographic area limits the generalizability of results. Further, the transition from in-person to remote data collection due to COVID-19 may have affected findings.

Discussion: This study contributes to the existing literature on the importance of decisional capacity to consent to research, particularly among vulnerable groups such as youth living with HIV. An examination of common decisional capacity errors is important for creating consent procedures that ensure participants truly understand and appreciate study components. Further research is needed on ways to improve decisional capacity for research consent, particularly among vulnerable populations including minors and people living with chronic illnesses such as HIV.