Clinical trial NCT00105339: Simplified Consent for HIV Vaccine Trials
Official title: Simplified Consent for HIV Vaccine Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Behavior
Keywords: consent form, vaccine trial
Simplified consent form
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2005-03-14
Enrollment: 255
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Adolescent Trials Network
name: Debra Murphy, PhD
role: STUDY_CHAIR
References: