Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention

Abstract

Background/aims: Early integration of behavioral and social sciences research into clinical trials can improve trial conduct and facilitate future implementation of biomedical interventions. We sought to examine participants' experiences in clinical trials with broadly neutralizing antibodies and describe the development of educational materials for use in future broadly neutralizing antibody research.

Methods: We conducted semi-structured interviews with trial participants in phase 1 trials evaluating safety and efficacy of broadly neutralizing antibodies for HIV prevention and treatment and key informants (i.e. trial staff involved in broadly neutralizing antibody research). Semi-structured interviews were transcribed and analyzed thematically. Based on findings from the interviews, we developed educational materials addressing concerns and misconceptions identified among trial participants with input from community and research stakeholders. Educational materials were used in subsequent clinical trials with broadly neutralizing antibodies. We evaluated trial staff's experiences with newly developed educational materials in follow-up key informant interviews.

Results: Although most participants were concerned about long-term harms related to the investigational product upon enrollment, absence of severe side effects in the trial led to an underestimation of risks related to the study during trial participation. Participants showed a poor understanding of what broadly neutralizing antibodies are and the differences between broadly neutralizing antibodies and other HIV prevention and treatment products, such as antiretrovirals. Many trial participants overestimated the possible public health impact of the broadly neutralizing antibody trials in which they were enrolled, associating broadly neutralizing antibody research with the development of vaccine or cure for HIV in the near future. Based on these concerns and misconceptions among trial participants, we developed a frequently asked questions document and adapted an existing educational video about broadly neutralizing antibodies. In follow-up interviews, key informants reported that materials helped address trial participants' concerns and questions related to the trial. Key informants reported using the educational materials not only during informed consent but also throughout trial participation, which contributed to making informed consent an "ongoing" process.

Conclusion: Integration of behavioral research into clinical trials with broadly neutralizing antibodies is key to identify and address key concerns among trial participants. Behavioral and social sciences research promotes communication between trial participants and biomedical researchers, facilitates engagement of participants and trial staff, and strengthens trial conduct. Development of educational materials collaboratively by behavioral and clinical scientists, trial staff, and community stakeholders is feasible and may help to address trial participants' concerns and misconceptions. Future research should evaluate the impact of educational materials in recruitment and retention of trial participants.

Trial registration: ClinicalTrials.gov NCT02850016 NCT02824536 NCT03254277 NCT03554408.

Keywords: HIV/AIDS; behavioral and social sciences research; broadly neutralizing antibodies; educational materials; trial participant engagement.

Figures

Figure 1.

Project timeline and engagement of different stakeholders

FIGURE 2.

Main changes to the educational video about bNAbs based on feedback from trial participants and research stakeholders. A) Original video described bNAbs as potential tools for HIV prevention. The revised version emphasized HIV prevention and treatment. B) Original video highlighted the question, “Can VRC01 [the bNAb being tested in the AMP study] prevent HIV infection?”. Based on the low perception of risk associated with the clinical trials among trial participants, we modified the original video to emphasize that ongoing trials are also evaluating safety and pharmacokinetics of bNAbs. C) Original video emphasized possible impacts of research with bNAbs on the development of an HIV vaccine in the future. Since many participants held the incorrect understanding that research with bNAbs could lead to a vaccine or cure in the near future, we modified the video to highlight only potential uses of bNAbs as long-acting tool for HIV prevention and treatment.

FIGURE 3.

A) Existing stakeholders and channels of communication in operation before BSSR project. B) Additional stakeholders and channels of communication created by BSSR project. Solid lines indicate existing stakeholders and channels of communication in place before the start of the behavioral research study. Dotted lines are stakeholders and channels of communication created or enhanced by the behavioral research initiative