How well do high-risk women who are candidates for HIV vaccine efficacy trials understand HIV vaccine trial procedures and risk? A report from the UNITY Trial


Back to Annual Meeting Page		American Public Health Association 133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA

3111.0: Monday, December 12, 2005 - Table 3

Abstract #116631

Mary Latka, PhD¹, Sebastian Bonner, PhD¹, Beryl Koblin, PhD², Pamela Brown-Peterside, PhD³, Debbie Lucy, MS³, and Princess Fortin, MPH¹. (1) Center for Urban Epidemiologic Studies, New York Academy of Medicine, 1216 Fifth Avenue, New York, NY 10029, 212-822-7284, mlatka@nyam.org, (2) Laboratory of Infectious Disease Prevention, The New York Blood Center, 310 East 67th Street, New York, NY 10021, (3) Project ACHIEVE, Laboratory of Epidemiology, The New York Blood Center, 391 East 149th St., Suite 405, Bronx, NY 10455

Background: There is little evidence that women targeted for HIV vaccine efficacy trials understand the procedures and risks associated with participating in them. Methods: We conducted two focus groups with African American and Latina, HIV-negative women recruited in the South Bronx, NYC. Groups were ethnically homogenous. Adult women were eligible if they had used non-injected illicit drugs and reported high-risk sex with men in the prior 3 months. A trained facilitator asked scripted questions about vaccine development and purpose; the immune system; study risks and benefits; and trial concepts (i.e. randomization; blinding). Groups were tape-recorded and observed by two researchers. Final interpretations derive from agreement among the observers and facilitator. Results: Findings differed by ethnicity. African American women were somewhat familiar with, but lacked understanding of, trial concepts. They regarded vaccine developers with distrust and perceived trial concepts as systems to protect against wrong-doing. “Randomization” was perceived as a form of discrimination; “placebo” was seen as a way to detect deviousness; “blinding” was described as a way to protect the researcher from blame if something went wrong. Latina women had less familiarity with, and equally poor understanding of, trial concepts, but expressed no distrust of vaccine developers. Women in both groups confused preventive vaccines with treatment, were dismissive of study risks, but were concerned with becoming HIV-infected via an experimental vaccine. Conclusion: Expressed familiarity with vaccine trial concepts should not be confused with comprehension. Innovative ways to explain complex trial concepts need to be further developed and evaluated.

Learning Objectives:

At the conclusion of the session, participants will

1. Understand prevalent misconceptions about the procedures involved in an HIV vaccine efficacy trial that are held by high-risk women who are candidates for these trials.
2. Articulate the ways that high-risk African American women who are candidates for vaccine trials express distrust of the research process.
3. Identify how high-risk African American and Latina women who are candidates for vaccine trials perceive risks associated with HIV vaccine efficacy trials.

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.

Emerging HIV/AIDS Issues for Discussion and Debate

The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA