BACKGROUND Financial incentives may aid recruitment to clinical trials, but evidence regarding ri... more BACKGROUND Financial incentives may aid recruitment to clinical trials, but evidence regarding risk/burden-driven variability in participant preferences for incentives is limited. We developed and tested a framework to support real-world decisions on recruitment budget. METHODS We included two phases: an Anchoring Survey, to ensure we could capture perceived unpleasantness on a range of life events, and a Vignette Experiment, to explore relationships between financial incentives and participants' perceived risk/burden and willingness to participate in high- and low-risk/burden versions of five vignettes drawn from common research activities. We compared vignette ratings to identify similarly rated life events from the Anchoring Survey to contextualize ratings of study risk. RESULTS In our Anchoring Survey (n = 643), mean ratings (scale 1 = lowest risk/burden to 5 = highest risk/burden) indicated that the questions made sense to participants, with highest risk assigned to losing house in a fire (4.72), and lowest risk assigned to having blood pressure taken (1.13). In the Vignette Experiment (n = 534), logistic regression indicated that amount of offered financial incentive and perceived risk/burden level were the top two drivers of willingness to participate in four of the five vignettes. Comparison of event ratings in the Anchoring Survey with the Vignette Experiment ratings suggested reasonable concordance on severity of risk/burden. CONCLUSIONS We demonstrated feasibility of a framework for assessing participant perceptions of risk for study activities and discerned directionality of relationship between financial incentives and willingness to participate. Future work will explore use of this framework as an evidence-gathering approach for gauging appropriate incentives in real-world study contexts.
During untreated human immunodeficiency virus type 1 (HIV-1) infection, virus-specific CD8 + T ce... more During untreated human immunodeficiency virus type 1 (HIV-1) infection, virus-specific CD8 + T cells partially control HIV replication in peripheral lymphoid tissues, but host mechanisms of HIV control in the central nervous system (CNS) are incompletely understood. We characterized HIV-specific CD8 + T cells in cerebrospinal fluid (CSF) and peripheral blood among seven HIV-positive antiretroviral therapy-naïve subjects. All had grossly normal brain magnetic resonance imaging and spectroscopy and normal neuropsychometric testing. Frequencies of epitope-specific CD8 + T cells by direct tetramer staining were on average 2.4-fold higher in CSF than in blood ( P = 0.0004), while HIV RNA concentrations were lower. Cells from CSF were readily expanded ex vivo and responded to a broader range of HIV-specific human leukocyte antigen class I restricted optimal peptides than did expanded cells from blood. HIV-specific CD8 + T cells, in contrast to total CD8 + T cells, in CSF and blood were a...
Journal of Clinical and Translational Science, 2020
OBJECTIVES/GOALS: The objective of this project was to determine the research volunteer recruitme... more OBJECTIVES/GOALS: The objective of this project was to determine the research volunteer recruitment capabilities and methodologies currently utilized by CTSA Hubs in order to disseminate recruitment best practices and create collaborations across institutions. METHODS/STUDY POPULATION: The CTSA Recruitment and Retention working group developed a REDCap survey to collect information about what participant recruitment and retention resources and processes are being used at CTSA institutions to support investigators. It was distributed to CTSAs between May and July 2019. The survey, consisting of over 50 multiple choice and short answer questions, is an updated version of a 2016 survey. Institutions reported on registry use, feasibility assessment use, clinical trial listings, experience recruiting special populations, program operations and evaluation, workforce education, social media use and other recruitment resources. RESULTS/ANTICIPATED RESULTS: 40 of the 64 CTSA institutions com...
BACKGROUND Financial incentives may aid recruitment to clinical trials, but evidence regarding ri... more BACKGROUND Financial incentives may aid recruitment to clinical trials, but evidence regarding risk/burden-driven variability in participant preferences for incentives is limited. We developed and tested a framework to support real-world decisions on recruitment budget. METHODS We included two phases: an Anchoring Survey, to ensure we could capture perceived unpleasantness on a range of life events, and a Vignette Experiment, to explore relationships between financial incentives and participants' perceived risk/burden and willingness to participate in high- and low-risk/burden versions of five vignettes drawn from common research activities. We compared vignette ratings to identify similarly rated life events from the Anchoring Survey to contextualize ratings of study risk. RESULTS In our Anchoring Survey (n = 643), mean ratings (scale 1 = lowest risk/burden to 5 = highest risk/burden) indicated that the questions made sense to participants, with highest risk assigned to losing house in a fire (4.72), and lowest risk assigned to having blood pressure taken (1.13). In the Vignette Experiment (n = 534), logistic regression indicated that amount of offered financial incentive and perceived risk/burden level were the top two drivers of willingness to participate in four of the five vignettes. Comparison of event ratings in the Anchoring Survey with the Vignette Experiment ratings suggested reasonable concordance on severity of risk/burden. CONCLUSIONS We demonstrated feasibility of a framework for assessing participant perceptions of risk for study activities and discerned directionality of relationship between financial incentives and willingness to participate. Future work will explore use of this framework as an evidence-gathering approach for gauging appropriate incentives in real-world study contexts.
During untreated human immunodeficiency virus type 1 (HIV-1) infection, virus-specific CD8 + T ce... more During untreated human immunodeficiency virus type 1 (HIV-1) infection, virus-specific CD8 + T cells partially control HIV replication in peripheral lymphoid tissues, but host mechanisms of HIV control in the central nervous system (CNS) are incompletely understood. We characterized HIV-specific CD8 + T cells in cerebrospinal fluid (CSF) and peripheral blood among seven HIV-positive antiretroviral therapy-naïve subjects. All had grossly normal brain magnetic resonance imaging and spectroscopy and normal neuropsychometric testing. Frequencies of epitope-specific CD8 + T cells by direct tetramer staining were on average 2.4-fold higher in CSF than in blood ( P = 0.0004), while HIV RNA concentrations were lower. Cells from CSF were readily expanded ex vivo and responded to a broader range of HIV-specific human leukocyte antigen class I restricted optimal peptides than did expanded cells from blood. HIV-specific CD8 + T cells, in contrast to total CD8 + T cells, in CSF and blood were a...
Journal of Clinical and Translational Science, 2020
OBJECTIVES/GOALS: The objective of this project was to determine the research volunteer recruitme... more OBJECTIVES/GOALS: The objective of this project was to determine the research volunteer recruitment capabilities and methodologies currently utilized by CTSA Hubs in order to disseminate recruitment best practices and create collaborations across institutions. METHODS/STUDY POPULATION: The CTSA Recruitment and Retention working group developed a REDCap survey to collect information about what participant recruitment and retention resources and processes are being used at CTSA institutions to support investigators. It was distributed to CTSAs between May and July 2019. The survey, consisting of over 50 multiple choice and short answer questions, is an updated version of a 2016 survey. Institutions reported on registry use, feasibility assessment use, clinical trial listings, experience recruiting special populations, program operations and evaluation, workforce education, social media use and other recruitment resources. RESULTS/ANTICIPATED RESULTS: 40 of the 64 CTSA institutions com...
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Papers by Laurie Lebo