Simplified Consent for HIV Vaccine Trials
Condition: Adolescent Behavior
Study type: Observational

Summary: 
      The main goal of this project is to develop and evaluate a simplified version of an HIV
      vaccine trial consent form designed for high-risk adolescents. The process will include: (1)
      reducing reading grade level by simplifying sentence structure and decreasing the use of
      infrequently used words; (2) re-organizing and categorizing the material for improved flow;
      and (3) developing a set of pictures to emphasize key concepts in the material. These
      materials will be tested among small focus groups of high-risk adolescents. A pre-post test
      design will be used to compare the simplified, adolescent-tailored consent form to one
      currently used in the National Institute of Allergy and Infection Diseases (NIAID) Vaccine
      Trial Information Booklet.
    

Detailed description: 
      In the United States, there has already been widespread preparation for the HIV vaccine
      efficacy trials. Since the first HIV vaccine trial enrolled volunteers in 1988, there have
      been numerous clinical trials of different vaccine candidates studied through NIAID's vaccine
      evaluation program. Since the outcome of a prophylactic HIV vaccine trial depends in part on
      the compliance of volunteers, one major effort that has been made is to determine the
      readiness of several high-risk populations to participate in vaccine trials. Numerous studies
      on the feasibility and willingness to participate in an adult HIV vaccine trial have already
      been conducted.

      Increased willingness to participate has been found to be associated with high-risk
      behaviors, lower education level, and being uninsured or covered by public insurance, as well
      as higher HIV incidence rates. Baseline knowledge of vaccine trial concepts was low among all
      of the populations studied.

      One population for which a vaccine could be extremely efficacious is high-risk adolescents--
      who face a lifetime of dealing with a chronic illness if infected with HIV. Adolescents at
      risk for HIV and therefore eligible and in need of a vaccine are likely to be low-income,
      poorly educated, and a disenfranchised population. Moreover, they are likely to have
      below-average reading and verbal comprehension skills, and difficulty with medical
      terminology. Issues of literacy and comprehension of informed consent become even more
      critical when dealing with populations with special vulnerabilities. To achieve truly
      informed consent for vaccine trials, Hodel (1994) has insisted that further research is
      crucial in determining what information is meaningful to potential participants in order for
      them to decide whether to participate. Potential HIV vaccine participants must fully
      understand complex concepts (e.g., that a person will test positive for HIV, even though they
      do not have the virus--they are "vaccine positive").

      Children and adolescents have developmental limitations on their abilities to comprehend
      information. With some exceptions, the majority of IRBs require parental consent for research
      involving minors. Typically, parent or guardian permission for research on minors may not be
      solicited for research with substantially greater than minimal risk unless there is direct
      benefit to the minor with a risk-benefit ratio at least as good as available alternatives.
      There are also special considerations for involvement of adolescents in research where needs
      of parents and of the adolescents may conflict in terms of concerns about privacy.

      Studies have suggested that simplifying the language and using short sentences have enhanced
      understanding. Other studies support the use of visual aids to enhance adolescent
      understanding and to enable adolescents to give truly informed consent.

      The aims of the project are to randomize adolescents at risk for HIV to either a simplified
      adolescent-friendly prototype condition, or to the standard condition in order to determine:

        1. if adolescents assigned to the simplified, adolescent-tailored prototype condition have
           significantly better comprehension scores than those assigned to the standard condition;

        2. if adolescents assigned to the simplified, adolescent-tailored prototype condition have
           significantly better recall scores than those assigned to the standard condition;

        3. if willingness to participate in a vaccine trial is significantly different among
           adolescents assigned to the simplified condition compared to the standard condition.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A sample of high-risk adolescents from 3 ATU sites will be recruited for both sets of focus
        groups, the Illustration Style Preference Group (n = 30; 10 per site) and the Review of
        Draft Groups (n = 45; 15 per site), and for the Comprehension/Recall Trial (n = 180; 60 per
        site), for total of 255 participants.
      
Keywords: consent form, vaccine trial; Simplified consent form