Abstract

Studies of clinical and research decision making and decision satisfaction often measure participant-reported decision conflict as an outcome. As part of our longitudinal study in an HIV cohort, we examine the relationship between pre-existing perceptions and subsequent decision conflict among those accepting and declining trial participation. We conducted a baseline questionnaire in a cohort of individuals diagnosed with acute HIV in Bangkok, Thailand, prior to their recruitment to a cure trial. Questions included respondents’ perceptions of anticipated benefits and harms of HIV cure trials, and a rating of their intention to participate in a hypothetical trial that includes interruption of antiretroviral therapy. During the following 16-24 months, individuals were offered participation in one of three HIV cure trials. Joiners and decliners completed the Decisional Conflict Scale (DCS) during longitudinal interviews starting at participation offer and concluding shortly after trial completion. We categorized participants into high, medium, or low decisional conflict levels based on their most recent DCS score. Using ordinal logistic regression, we examined the relationship between decisional conflict category and pre-existing perceptions using a partial proportional odds model. Of 250 participants completing the baseline questionnaire, 74 have been offered participation in one of three trials, and consented to interviews. Baseline assessment of potential trial participation benefit to the individual, potential benefit to science, and the participants’ intention to participate in a trial all were correlated with decision conflict score, while potential risk to self was not. When participants’ most recent decision conflict scores were categorized, ordinal regression indicated the strongest association between intention to participate and subsequent decision conflict category. Participant or decliner status was not associated with decision conflict. Our results suggest a strong impact of baseline intention to participate on later decision conflict for trial joiners and decliners, consistent with several other studies.

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