Evaluating the Impact of Incentives on Clinical Trial Participation

NCT04809636 | Unknown

• 1 other identifier: 59270
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Aging; Incentives

Keywords

hiv; aging; incentives

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

This is not an interventional study OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• people living with HIV
• biomedical HIV researchers
• IRB members/bioethicists involved in HIV research

You may not qualify if:

• people under 18 years of age
• people living outside of the United States
• people who do not speak English

Sponsors & Collaborators

• University of California, Riverside: lead
• University of South Florida: collaborator

Study Sites (1)

UC Riverside

Riverside, California, 92521, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34817381 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 22, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)