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      Enhancing HIV vaccine trial consent preparedness among street drug users.

      Journal of empirical research on human research ethics : JERHRE
      AIDS Vaccines, Adult, Clinical Trials as Topic, ethics, Female, Health Knowledge, Attitudes, Practice, Humans, Informed Consent, Male, Middle Aged, Patient Education as Topic, Patient Selection, Risk, Street Drugs, Substance-Related Disorders, complications, Trust, United States

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          Abstract

          This research used open-ended and true-false questions to assess the preparedness of 96 ethnically diverse, economically and socially marginalized adult street drug users to consent to participate in HIV vaccine trials (HVT). Specific areas of consent vulnerability included misconceptions about: (1) the recuperative value and risk of vaccines in general; (2) the presence of the HIV virus within the vaccine and the possibility of contracting or transmitting HIV as a consequence of participation; (3) inclusion criteria and experimental blinds; and (4) distrust in the medical and research establishments. A brief HVT lesson administered to 30 participants was effective in correcting specific HVT knowledge misperceptions and increasing certain, but not all areas of HVT trust. Assessment of post-lesson responses to ethics-relevant questions provides information on respondents' attitudes toward AIDS safe behavior, research risks and benefits, monetary compensation, and willingness to participate. Implications for enhancing informed consent for HVT involving active drug users are discussed.

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