NCT00105339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2005

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

March 11, 2005

Last Update Submit

February 27, 2017

Conditions

Adolescent Behavior

Keywords

consent form, vaccine trialSimplified consent form

Study Arms (3)

Illustration Style Preference Group

Ten participants at each site will be invited to attend a focus group to determine their comfort with and preference for one of four styles of illustration. The same two concepts will be presented in each of the four styles and ratings will be obtained from all participants. Detailed information on why participants rated each of the styles the way they did will also be obtained by reviewing comments on the rating sheets and audiotapes of the groups. Groups will be run by the study coordinator at the Florida and New York sites, and by Dannie Hoffman, protocol coordinator, in Los Angeles, using a focus group script developed by Dr. Murphy.

Review of Draft Focus Group

Lori Perez will travel to each site from Westat and conduct Review of Draft Focus Groups with adolescents and young adults (n per site = approximately 10 - 15) to collect final feedback on the adolescent friendly version (present key pieces of the adolescent friendly version and obtain feedback on the wording and the illustrations). Based on the focus group feedback, the research team will finalize the adolescent friendly materials.

Comprehension/Recall Assessment

The assessment will be read to the participants to preclude reading problems. Responses will be recorded by the interviewer on the assessment instrument.

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking
  • Not shown to be at risk through use of screener
  • Unwilling/unable to provide informed consent/assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital of Los Angeles

Los Angeles, California, 90054-0700, United States

Location

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, 33301, United States

Location

Mount Sinai Medical Center

New York, New York, 10128, United States

Location

Related Links

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Debra Murphy, PhD

    Adolescent Trials Network

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2005

First Posted

March 14, 2005

Study Start

December 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

March 1, 2017

Record last verified: 2016-02

Locations

US(3)