How Biomedical HIV Prevention Trials Incorporate Behavioral and Social Sciences Research: A Typology of Approaches

Amy Corneli,Stuart Rennie,Gail Henderson,Karen Meagher,Holly Peay

doi:10.1007/s10461-018-2358-0

Abstract

In the field of biomedical HIV prevention, researchers have meaningfully incorporated behavioral and social sciences research (BSSR) into numerous clinical trials, though the timing and degree of integration have been highly variable. The literature offers few frameworks that systematically characterize these collaborations. To fill this gap, we developed a typology of BSSR approaches within biomedical HIV prevention research. Focusing on trials that had safety and/or efficacy endpoints, we identified five approaches for combining BSSR and clinical research: formative, embedded, parallel, explanatory, and implications. We describe each approach and provide illustrative examples. By offering a shared vocabulary for distinguishing the timing and design of collaborative BSSR and clinical research, this typology can facilitate greater transparency in collaborators’ expectations and responsibilities, and help collaborators address challenges likely to be associated with such interdisciplinary research.

Highlights

Over the past 2 decades, behavioral and social sciences research (BSSR) has increasingly been combined with clinical research in fields as disparate as cancer, heart disease, genetics, and HIV/AIDS [1, 2]
In the field of HIV prevention, BSSR has been situated both within and alongside clinical research endeavors. It is commonplace for biomedical HIV prevention trials to include substantial BSSR components that contribute to developing the clinical research and understanding the context of the clinical research findings, while furthering both theoretical and empirical BSSR aims
We reviewed only BSSR studies related to HIV prevention clinical trials that had safety and/or efficacy endpoints

Summary

Introduction

Over the past 2 decades, behavioral and social sciences research (BSSR) has increasingly been combined with clinical research in fields as disparate as cancer, heart disease, genetics, and HIV/AIDS [1, 2]. We excluded (1) trials with only standard quantitative assessments on product acceptability, sexual behavior, and adherence; (2) standalone BSSR related to biomedical HIV prevention or ethics studies in which the primary association with the clinical trial was to gain access to the trial population for research purposes unrelated to the trial’s findings or implications; and (3) open-label studies.

Objectives

Results

Conclusion