Simplified Consent for HIV Vaccine Trials
Tracking Information | |||||
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First Received Date ICMJE | March 11, 2005 | ||||
Last Updated Date | September 5, 2011 | ||||
Start Date ICMJE | December 2003 | ||||
Primary Completion Date | February 2004 (final data collection date for primary outcome measure) | ||||
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Change History | Complete list of historical versions of study NCT00105339 on ClinicalTrials.gov Archive Site | ||||
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Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Simplified Consent for HIV Vaccine Trials | ||||
Official Title ICMJE | Simplified Consent for HIV Vaccine Trials | ||||
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. |
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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:
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | |||||
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. |
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Condition ICMJE | Adolescent Behavior | ||||
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Study Group/Cohort (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 255 | ||||
Completion Date | February 2004 | ||||
Primary Completion Date | February 2004 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 15 Years to 19 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00105339 | ||||
Other Study ID Numbers ICMJE | ATN 006 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
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Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |