Evaluating the Impact of Incentives on Clinical Trial Participation

• Conditions: Aging; Incentives; Hiv

• Registration Number: NCT04809636
• Lead Sponsor: University of California, Riverside

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-18
• Last Update Submitted: 2021-03-18
• Study First Posted: 2021-03-22
• Last Update Posted: 2021-03-22
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pilot testing vignettes for incentive decision making	3 months	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).
characterize how people living with HIV assess incentives	3 months	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
characterize key stakeholders' views on and assessment of incentives	3 months	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.

Trial Locations

Locations (1)

UC Riverside; 🇺🇸 Riverside, California, United States