Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105339
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2005-03-11
Brief Title:
Simplified Consent for HIV Vaccine Trials
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Simplified Consent for HIV Vaccine Trials
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NIAIDs 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None