HIV Infections Clinical Trial
Official title:
Exploring Decision Making of Hispanics and African Americans With HIV/AIDS Participating in Clinical Trials
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.
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.
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