The Flawed Reliance on Randomized Controlled Trials in Studies of HIV Behavioral Prevention Interventions for People Who Inject Drugs and Other Populations

Abstract

This article discusses ways in which randomized controlled trials do not accurately measure the impact of HIV behavioral interventions. This is because: 1. Such trials measure the wrong outcomes. Behavior change may have little to do with changes in HIV incidence since behavior change in events between HIV-concordant people have no impact on incidence. Even more important, the comparison of HIV incidence rates between study arms of individual-level RCTs does not measure the true outcome of interest—whether or not the intervention reduces HIV transmission at the community level. This is because this comparison cannot measure the extent to which the intervention stops transmission by HIV-infected people in the study to those outside it. (And this is made even worse if HIV-infected are excluded from the evaluation of the intervention.) 2. There are potential harms implicit in most cognitively oriented behavioral interventions that are not measured in current practice and may not be measurable using RCTs. Intervention trials often reinforce norms and values of individual self-protection. They rarely if ever measure whether doing this reduces community trust, solidarity, cohesion, organization, or activism in ways that might facilitate HIV transmission. 3. Many interventions are not best conceived of as interventions with individuals but rather with networks, cultures of risks, or communities. As such, randomizing individuals leads to effective interventions that diffuse protection through a community; but these are evaluated as ineffective because the changes diffuse to the control arm, which leads to systematic and erroneous reductions in the evaluated effectiveness as RCTs measure it. The paper ends by discussing research designs that are superior to individual-level RCTs at measuring whether an intervention reduces or increases new HIV transmission.

Keywords:

• research design
• randomized controlled trials
• RCTs
• behavioral interventions
• HIV transmission
• reducing infection
• effectiveness

Notes

¹ Efforts to address this weakness by comparing study arms in terms of the extent to which HIV-positive persons report engaging in behaviors that can transmit the virus with people they believe to be uninfected can offer some insight, but are greatly flawed to the extent that infected participants lack knowledge of their partners’ serostatus and/or report on only a subset of those with whom they engage in potential transmission behaviors.

² While effectiveness RCTs, which by virtue of broader inclusion criteria and other aspects of their design, are more predictive of real world outcomes for those in the intervention when the intervention is rolled out in practice, they still ignore any network or community level impact, and usually still rely on outcomes variables with the limitations discussed (Gartlehner, Hansen, Nissman, Lohr, & Carey, 2006; Glasgow, Lichtenstein, & Marcus, 2003; Singal, Higgins, & Waljee, 2014).

Additional information

Notes on contributors

Samuel R. Friedman

Samuel R. Friedman, PhD, US, is Director of Infectious Disease Research at National Development and Research Institutes, Inc. and the Director of the Interdisciplinary Theoretical Synthesis Core in the Center for Drug Use and HIV Research, New York City. He also is associated with the Department of Epidemiology, Johns Hopkins University, and with the Dalla Lana School of Public Health, University of Toronto. Dr. Friedman is an author of about 450 publications on HIV, hepatitis C, hepatitis C, STI, and drug use epidemiology and prevention. Honors include a NIDA Avant Garde Award (2012), the International Rolleston Award of the International Harm Reduction Association (2009), the first Sociology AIDS Network Award for Career Contributions to the Sociology of HIV/AIDS (2007), Senior Scholar Award of the Alcohol, Drugs, and Tobacco Section of the American Sociological Association (2010), and a Lifetime Contribution Award, Association of Black Sociologists (2005). He has published many poems in a variety of publications and a book of poetry (Seeking to make the world anew: Poems of the Living Dialectic. 2008. Lanham, Maryland: Hamilton Books).

David C. Perlman

David C. Perlman, MD, US, is Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Associate Chief, Infectious Diseases at Mount Sinai Beth Israel in New York. He is also an Investigator in the Baron Edmond de Rothschild Chemical Dependency Institute and Director of the Infectious Disease and Biomedical Core in the Center for Drug Use an HIV Research. His research interests focus on clinical, epidemiologic, health service and care continuum aspects of HCV and other infections, particularly among persons who use drugs and among HIV infected persons.

Danielle C. Ompad

Danielle C. Ompad, PhD, US, is a Clinical Associate Professor at NYU's Global Institute of Public Health. She is also the Deputy Director of the NYU College of Nursing's Center for Drug Use and HIV Research (CDHUR) and a faculty affiliate of NYU Steinhardt's Center for Health, Identity, Behavior and Prevention Studies (CHIBPS). Dr. Ompad completed her BS in Biology at Bowie State University and her MHS and PhD in infectious disease epidemiology at the Johns Hopkins University School of Public Health. She is an epidemiologist with extensive experience in the design, conduct and analysis of community-based cross-sectional and prospective studies focusing on illicit drug use, risky sexual behavior, and adult access to vaccines in urban settings.