HIV Infections Clinical Trial
Official title:
Exploring Decision Making of Hispanics and African Americans With HIV/AIDS Participating in Clinical Trials
Verified date | April 26, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | April 26, 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Acevedo MC. The role of acculturation in explaining ethnic differences in the prenatal health-risk behaviors, mental health, and parenting beliefs of Mexican American and European American at-risk women. Child Abuse Negl. 2000 Jan;24(1):111-27. — View Citation
Alderete E, Vega WA, Kolody B, Aguilar-Gaxiola S. Lifetime prevalence of and risk factors for psychiatric disorders among Mexican migrant farmworkers in California. Am J Public Health. 2000 Apr;90(4):608-14. — View Citation
Allen M, Israel H, Rybczyk K, Pugliese MA, Loughran K, Wagner L, Erb S. Trial-related discrimination in HIV vaccine clinical trials. AIDS Res Hum Retroviruses. 2001 May 20;17(8):667-74. — View Citation
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