Objective: Describe the negative social impacts (NSIs) and their predictors in an HIV vaccine efficacy trial.
Methods: Volunteers in the North American phase 3 trial of AIDSVAX B/B vaccine were questioned semiannually about NSIs. Multivariable logistic models identified independent predictors of NSI reporting.
Results: Of 5417 volunteers (94% male), 18% reported at least 1 NSI. Most events occurred early during trial participation and involved concerns by family and friends that the volunteer was HIV-infected or at risk for infection. Problems with disability/life insurance and employment occurred less frequently (<1%). Individuals who became HIV-infected reported NSIs similar to HIV-negative volunteers. In multipredictor analysis of male volunteers, NSI reporters were younger (adjusted odds ratio [ORAdj] = 1.6, 95% confidence interval [CI]: 1.2 to 2.1 and ORAdj = 1.4, 95% CI: 1.1 to 1.8 for ages 18 to 25 years and 26 to 35 years vs. ≥46 years, respectively), enrolled at sites with 50 or fewer volunteers (ORAdj = 2.3, 95% CI: 1.7 to 3.1), or lived in cities with high AIDS case rates (ORAdj = 1.4, 95% CI: 1.1 to 1.8).
Conclusions: A modest proportion of vaccine efficacy trial volunteers reported problems in interpersonal relationships from trial participation. Serious harms involving insurance and employment were rare. Strategies to prevent harm from disclosure, particularly for younger volunteers and those from high seroincidence sites, may reduce NSIs in future trials.
From the *AIDS Office, San Francisco Department of Public Health, San Francisco, CA; †Department of Medicine, ‡Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA; §Northrop Grumman Information Technology, Centers for Disease Control and Prevention Information Technology Support, Atlanta, GA; ∥Centers for Disease Control and Prevention, Atlanta, GA; and ¶VaxGen, Inc., Brisbane, CA.
Received for publication April 9, 2007; accepted July 24, 2007.
An earlier analysis of these data was presented at the XV International AIDS Conference, Bangkok, Thailand, July 11-16, 2004, and at the Joint World Health Organization-United Nations Program on HIV/AIDS Consultation on Gender, Age, and Race Factors in HIV Vaccine-Related Research and Clinical Trials, Lausanne, Switzerland, August 26-28, 2004.
Supported by the Centers for Disease Control and Prevention through contract 200-1999-00129.
The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.
Correspondence to: Jonathan Fuchs, MD, MPH, 25 Van Ness Avenue, Suite 500, San Francisco, CA 94102-6033 (e-mail: email@example.com).