Conceptual framework for behavioral and social science in HIV vaccine clinical research

Abstract

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance.

Drug Users’ Willingness to Encourage Social, Sexual, and Drug Network Members to Receive an HIV Vaccine: A Social Network Analysis

“…Social concerns reported in previous studies include fear that others will perceive vaccination as a sign of promiscuity [9–11] and that family members [6, 7] and intimate partners [6, 7, 11, 12] will have a negative reaction. As a result, recent conceptual models of HIV vaccine uptake and clinical trial participation include social networks, norms, and peer influence among the key determinants [10, 13]. …”

Lessons Learned from HIV Vaccine Clinical Efficacy Trials

“…Another lesson learned from various trials conducted thus far, is the importance of conducting social and behavioral science research in conjunction with HIV vaccine trials [91-93]. These studies provide valuable information relevant to numerous aspects of vaccine development and implementation such as community engagement, trial recruitment and retention, risk of HIV exposure, and vaccine efficacy among different participant subgroups.…”

Preparing for the Unexpected

“…In the conduct of HIV prevention trials, social and behavioral science provides the framework and tools 19 for investigating factors which may have an effect on observed intervention efficacies. Social and behavioral science disciplines provide a wealth of theoretical and empirical evidence with which to inform HIV prevention trials.…”

“…23 In the varied contexts in which multicenter trials are conducted, an awareness of and appropriate response to the perspectives, practices and expectations of diverse target groups allows researchers to anticipate participation and retention rates, adherence, HIV exposure, as well as likely dissemination and uptake of efficacious interventions. Utilizing a conceptual framework for social and behavior science in HIV prevention trial research 19 can assist in the integration and concurrent conduct of biomedical and social and behavioral science research in the context of trials. Below we discuss three factors: potential study populations to include and retain in trials, quantifying HIV exposure and documenting intervention dose (Figure 1).…”