Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study

Abstract

HIV cure research carries serious risks and negligible benefits. We investigated how participants understand these risks and what influences their willingness to participate. Through internet-based and in-person convenience sampling, 86 HIV+ participants completed an experimental survey. Participants were randomized to read a standard consent form describing a hypothetical HIV cure study or one adapted using Fuzzy Trace Theory—a decision-making model to facilitate complex information processing. We measured consent understanding and cognitive (e.g., safe/harmful) and affective (e.g., concerning, satisfying) evaluations of HIV cure research. Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate. Consent processes can use decision-making theories to facilitate comprehension of study information.

The Importance of Social Engagement in the Development of an HIV Cure: A Systematic Review of Stakeholder Perspectives

“…Several studies, reporting on both qualitative and quantitative results, found that most PWHIV were supportive of HIV cure research and believed that it was important, as it could mean scientific and health advancements [ 27 - 32 ]. Findings of primarily cross-sectional survey research showed that PWHIV’s hypothetical WTP in different forms of HIV cure research was relatively high, with most studies reporting that at least 50% of the research population is willing to participate (Table 2 ) [ 23 , 24 , 26 , 29 – 42 ]. It is noteworthy that, in studies where HIV cure research was more extensively defined with riskier procedures, WTP was lower [ 24 , 34 , 38 , 39 , 42 – 45 ].…”

“… Protière, Spire [ 32 ] France Mixed method (Q-sort exercise) WTP in HIV Cure-related clinical trials (Q-sort exercise) 63% WTP 34% yes, perhaps N.A. Sauceda, Dubé [ 26 ] United States Quantitative (experiment) WTP to participate in HIV cure clinical trial based on the informed consent form 59% WTP (no significant difference because of the informed consent form) Positive affective evaluation in informed consent forms was associated with a higher WTP Simmons, Kall [ 38 ] Multi-country Quantitative (survey) WTP in HIV cure research 95% were interested in participating in cure studies Factors associated with WTP with substantial risk: CD4 count: 201–350 cells/μL compared with a current CD4 count of ≥ 350 cells/μL had a higher WTP Nationality: USA‐born compared with UK‐born had a higher WTP Knowledge: little or no knowledge about HIV or HIV treatments compared with excellent/good knowledge had lower WTP Age: Those aged ≥ 65 years compared with those aged 45–64 years had lower WTP No factor was associated with ATI WTP in HIV cure research with substantial risk defined as severe/moderate side effects without personal benefit 59% were willing to accept substantial risks WTP in ATI 62% were willing to have treatment interruption van Paassen, Dijkstra [ 42 ] Netherlands Qualitative (interviews) Scenario 1 brief ATI 11/20 participants were willing to participate N.A. Scenario 2 extended ATI 1/20 participants were willing to participate Wozniak, Cerqueira [ 39 ] Brazil Quantitative (survey) …”

“…Similarly, PWHIV who perceived cure research as not burdensome, low risk [ 35 , 41 ], and as having high benefit [ 33 , 35 ], also had higher hypothetical WTP. Higher hypothetical WTP was also associated with taking advice from healthcare professionals [ 40 ], autonomous decision-making [ 41 ], and positive affective evaluations in informed consent forms [ 26 ]. Furthermore, self-identification as an HIV activist and self-confidence as PWHIV were associated with higher hypothetical WTP [ 36 ].…”

Ethics of HIV cure research: an unfinished agenda

“…In a separate review, Bromwich and colleagues outlined key informed consent challenges for HIV cure research: (1) how trial information is communicated to potential participants, (2) whether potential participants fully understand key features of the clinical trials in which they are being asked to participate, and (3) the degree to which potential study participants’ motivations to enroll in low-benefit/high-risk research are altruistically motivated [ 18 ]. Overall, it seems clear that empirical research and further deliberation is needed to strengthen and improve the quality of informed consent in general [ 148 – 150 ].…”

Navigating ethical challenges of conducting randomized clinical trials on COVID-19

“…In a review of several studies of FTT and outcomes, gist information was more strongly associated with decision making when compared to verbatim information alone [27]. If FTT promotes processing of the gist meaning of consent form information, rather than verbatim recall, it can assist individuals to make better informed choices about risk of research participation, particularly in high-risk studies [28]. Thus, the FTT may be used to develop patient decision aids, thereby making it easier to communicate basic RCT information like study purpose, potential risks, benefits, alternatives and key study procedures.…”