Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed-Methods, Community-Engaged Study (Preprint)

BACKGROUND Monetary incentives in research are frequently used to support participant recruitment and retention. However, scant empirical data exist regarding how researchers decide upon the type and amount of incentives offered. Likewise, there is little guidance to assist study investigators and institutional review boards (IRBs) in their decision-making on incentives. Monetary incentives, in addition to other factors such as the risk of harm or other intangible benefits, guide individuals’ decisions to enroll in research studies. These factors emphasize the need for evidence-informed guidance for study investigators and IRBs when determining the type and amount of incentives to provide to research participants. OBJECTIVE The specific aims are to: Aim 1) characterize key stakeholders’ views on and assessment of incentives in biomedical HIV research; Aim 2) reach consensus among stakeholders on the factors considered when choosing research incentives, including their relative importance, and, Aim 3) pilot test the use of the guidance from Aims 1 and 2 by presenting stakeholders vignettes of hypothetical research studies for which they will choose corresponding incentive types. METHODS Our two-year study involves monthly, active engagement with a stakeholder advisory board (SAB) of people living with HIV, researchers, and IRB members. For Aim 1, we will conduct a nationwide survey (N=300) among people living with HIV to understand their views regarding incentives used in HIV research. In Aim 2, we will collect qualitative data using focus groups with people living with HIV (n=60) and key informant interviews with stakeholders involved in HIV research (people living with HIV, IRB members, biomedical HIV researchers; n=36), to extend and deepen our understanding of how incentives in HIV research are perceived. These participants will also complete a conjoint analysis experiment to understand the relative importance that key attributes of HIV research studies have on study participation. Data from the nationwide survey (Aim 1) will be triangulated with the qualitative and conjoint analysis data (Aim 2) to create 25 “vignettes” that describe hypothetical HIV research studies. Finally, (Aim 3) individuals from each stakeholder group will select the most appropriate incentive they feel should be used in each of the 25 vignettes. RESULTS The SAB began monthly meetings in March 2021. All study aims are expected to be completed by December 2022. CONCLUSIONS By studying the role of incentives in HIV clinical trial participation, we will establish a decision-making paradigm to guide the choice of incentives for HIV –and eventually other types of similar research –to facilitate ethical recruitment of clinical research participants. CLINICALTRIAL ClinicalTrials.gov NCT04809636; https://clinicaltrials.gov/ct2/show/NCT04809636