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Decision-Making of Hispanics and African-Americans With HIV/AIDS Participating in Clinical Trials

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00394004
First received: October 28, 2006
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition
HIV Infections
Acquired Immunodeficiency Syndrome

Study Type: Observational
Official Title: Exploring Decision Making of Hispanics and African Americans With HIV/AIDS Participating in Clinical Trials

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 35
Study Start Date: October 2006
Estimated Study Completion Date: April 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

  • INCLUSION CRITERIA:

    1. Patients enrolled in at least one active NIH HIV/AIDS protocol.
    2. Age greater than or equal to 18 years.
    3. Willingness and capacity to provide informed consent.
    4. Self-identifying as Hispanic/Latino or African American/Black.
    5. Be HIV-positive.
    6. Willing to have comments recorded on audiotape.

EXCLUSION CRITERIA:

  1. Age less than 18 years.
  2. Self-identifying as other than Hispanic/Latino or African American/Black.
  3. Patients only enrolled in the Natural History HIV Protocol, 95-I-0072, Clinical Virologic and Immunologic Evaluation and Monitoring of Patients with Known or Suspected HIV Infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394004

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00394004     History of Changes
Other Study ID Numbers: 070015, 07-CC-0015
Study First Received: October 28, 2006
Last Updated: April 27, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Decision Making
Health Disparities
Hispanic
 African-American
Clinical Trials
HIV Positive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on March 14, 2013