Simplified Consent for HIV Vaccine Trials

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.

Inclusion Criteria:

- Ages 15 to 19 years (self identified)

- At risk for HIV/AIDS as determined by responses to an anonymous screen for sexual
risk

- Giving assent or consent, depending on age

- English-speaking

Exclusion Criteria:

- Non-English speaking

- Not shown to be at risk through use of screener

- Unwilling/unable to provide informed consent/assent