Evaluating the Impact of Incentives on Clinical Trial Participation

Evaluating the Impact of Incentives on HIV Related Clinical Trial Participation

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.

Study Overview

• Status: Unknown
• Conditions: Aging; Hiv; Incentives
• Intervention / Treatment: Other: This is not an interventional study

• Study Type: Observational
• Enrollment (Anticipated): 360

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92521
      • Recruiting
      • UC Riverside
      • Contact: Christine Davis; Phone Number: 951-827-5733; Email: christine.davis@medsch.ucr.edu
      • Principal Investigator: Brandon Brown, PhD
      • Sub-Investigator: Andrea Polonijo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We will recruit patient partners, biomedical HIV researchers and IRB members/bioethicists involved in HIV research and patient partners with HIV co-morbidities (depression, heart disease, arthritis). For the patient populations, we will target men (including MSM) and women aging with HIV, cis and transgender women, and youth (age 18+) of color, but participation will be open to everyone over 18 years of age living with HIV who speaks English and live in the United States.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Riverside
• Collaborators: University of South Florida

Publications and helpful links

General Publications

• Galea JT, Greene KY, Nguyen B, Polonijo AN, Dube K, Taylor J, Christensen C, Zhang Z, Brown B. Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed Methods, Community-Engaged Study. JMIR Res Protoc. 2021 Nov 23;10(11):e33608. doi: 10.2196/33608.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: aging; hiv; incentives
• Other Study ID Numbers: 59270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No