Evaluating the Impact of Incentives on Clinical Trial Participation

Hiv Clinical Trial

Official title:

Evaluating the Impact of Incentives on HIV Related Clinical Trial Participation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809636
• Other study ID #: 59270
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: University of California, Riverside
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Hiv
• Incentives

Intervention

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

Locations

Country	Name	City	State
United States	UC Riverside	Riverside	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Riverside	University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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