Evaluating the Impact of Incentives on Clinical Trial Participation

Study Overview
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Brief Summary
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The objective of this study is to investigate the impact of incentives on clinical trial participation. 1) characterize key stakeholders' views on and assessment of incentives, 2) reach consensus among stakeholders on the factors to be considered when choosing incentives and their relative importance, 3) pilot test using vignettes for incentive decision making. We hypothesize that potential study participants make trade-offs regarding the characteristics of a research study when deciding whether to volunteer. This amendment is to document IRB reliance between UCR and USF.

Official Title
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Evaluating the Impact of Incentives on HIV Related Clinical Trial Participation

Conditions
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Hiv, Aging, Incentives

Intervention / Treatment
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* Other: This is not an interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people living with HIV biomedical HIV researchers IRB members/bioethicists involved in HIV research Exclusion Criteria: people under 18 years of age people living outside of the United States people who do not speak English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: This is not an interventional study|While this is not an intervention, there will be separate participants for the survey study and for the other components of the study (focus groups, interviews, conjoint analysis, piloting the vignettes|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characterize how people living with HIV assess incentives | we will conduct a 20 question quantitative survey of a nationally representative sample of people living with HIV asking about specific study payment information and scenarios | 3 months | 
| characterize key stakeholders' views on and assessment of incentives | focus groups, and key informant interviews will be used to characterize key stakeholders' (people aging with HIV, IRB members, researchers) views on and assessment of incentives, with qualitative analysis of text done using RaDAR. We will use Conjoint Analysis (CJA) to estimate the relative importance (also called weight) that participants place on each study characteristic when choosing between different hypothetical studies. | 3 months | 
| pilot testing vignettes for incentive decision making | We will develop HIV related vignettes (hypothetical scenarios) utilizing the data from outcomes 1 and 2. Specifically, once we have 6 to 8 study characteristics from Aim 2, and the final number of choices (2 - 3) per characteristic, we will use a factorial design to create 25 vignettes (hypothetical scenarios). Individuals from each group (i.e., study participants, researchers, and IRB members) will select the most appropriate incentive from a list of possibilities based on various scenarios. These vignettes will be based on studies identified in the literature and a review of consent forms and created in conjunction with the external advisory board (including pre-testing and revision prior to finalization). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hiv, aging, incentives