Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-29 @ 12:00 PM
Study NCT ID:
NCT00394004
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decision-Making of Hispanics and African-Americans With HIV/AIDS Participating in Clinical Trials
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Exploring Decision Making of Hispanics and African Americans With HIV/AIDS Participating in Clinical Trials
Status:
COMPLETED
Status Verified Date:
2011-04-26
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:
This study will use focus groups and in-depth individual interviews to explore factors that influence the decision of Hispanics and African-Americans with HIV/AIDS to participate in a research study.
HIV-positive Hispanic and African-American patients 18 years of age and older who are enrolled in an NIH HIV/AIDS protocol may be eligible for Part 1, Part 2, or both parts of this study, as follows:
Part 1 - Focus group
Focus group participants of from six to ten people are interviewed together during a one-time, 2-hour tape-recorded session to explore how they arrived at their decision to enroll in a research study. The group discussion is led by a moderator and a facilitator. Before the session begins, participants complete questionnaires that include information about their age, race, ethnicity, education and social support. Hispanic participants also complete a questionnaire about language preference. At the end of the focus group, participants are offered to be interviewed individually, as described below.
Part 2 - In-depth interview
An investigator conducts a one-on-one in-depth interview with the participant while a second person observes and tape records the interview. The interview may take from 1 1/2 to 2 hours to complete. Participants who were not in a focus group are asked to complete questionnaires as described in Part 1 above.
HIV-positive Hispanic and African-American patients 18 years of age and older who are enrolled in an NIH HIV/AIDS protocol may be eligible for Part 1, Part 2, or both parts of this study, as follows:
Part 1 - Focus group
Focus group participants of from six to ten people are interviewed together during a one-time, 2-hour tape-recorded session to explore how they arrived at their decision to enroll in a research study. The group discussion is led by a moderator and a facilitator. Before the session begins, participants complete questionnaires that include information about their age, race, ethnicity, education and social support. Hispanic participants also complete a questionnaire about language preference. At the end of the focus group, participants are offered to be interviewed individually, as described below.
Part 2 - In-depth interview
An investigator conducts a one-on-one in-depth interview with the participant while a second person observes and tape records the interview. The interview may take from 1 1/2 to 2 hours to complete. Participants who were not in a focus group are asked to complete questionnaires as described in Part 1 above.
Detailed Description:
The realities of health disparities are well documented. The HIV/AIDS epidemic is a health crisis for African Americans and a serious threat to the Hispanic Community. In 2003, African Americans accounted for 50% of the new HIV/AIDS cases. According to the U.S. Census Bureau, Census 2000 Brief, African Americans/Blacks make up 12.9% of the U.S. population and account for 40% of the 929,985 estimated AIDS cases. The U. S. Census Bureau also reports as of May 2001 Hispanics account for 12.5% of the population. In 2002, the Centers for Disease Control (CDC) reported that Hispanics accounted for 13% of the new cases with an increase of 26% since 1999. As the numbers indicate, HIV/AIDS is a serious concern to both African Americans and Hispanics.
Additionally there is an underrepresentation of Hispanics and African Americans in clinical trials. It is critical that Hispanics and African Americans with HIV/AIDS be included in clinical trials. Minority underrepresentation in clinical trials prohibits generalizability of results and is of significant concern.
In this study, we propose examining the decision making processes of Hispanics and African Americans with HIV/AIDS around their decision to enter a clinical trial in an effort to develop a future instrument to measure decision making in this population. This is a descriptive, exploratory mixed methods study designed to examine the decision-making process among a convenience sample of minority patients who are enrolled in active HIV/AIDS protocols.
Through focus groups and in-depth interviews, participants will be asked about the factor(s) that influence their decision to participate in research. By asking the participants directly, we may gain a better understanding of their decision-making process. Obtaining these data may provide strategies for facilitating inclusion of Hispanics and African Americans with HIV/AIDS into clinical trials.
Additionally there is an underrepresentation of Hispanics and African Americans in clinical trials. It is critical that Hispanics and African Americans with HIV/AIDS be included in clinical trials. Minority underrepresentation in clinical trials prohibits generalizability of results and is of significant concern.
In this study, we propose examining the decision making processes of Hispanics and African Americans with HIV/AIDS around their decision to enter a clinical trial in an effort to develop a future instrument to measure decision making in this population. This is a descriptive, exploratory mixed methods study designed to examine the decision-making process among a convenience sample of minority patients who are enrolled in active HIV/AIDS protocols.
Through focus groups and in-depth interviews, participants will be asked about the factor(s) that influence their decision to participate in research. By asking the participants directly, we may gain a better understanding of their decision-making process. Obtaining these data may provide strategies for facilitating inclusion of Hispanics and African Americans with HIV/AIDS into clinical trials.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 07-CC-0015 | None | None | View |