HIV InfectionsNCT00394004
Decision-Making of Hispanics and African-Americans With HIV/AIDS Participating in Clinical Trials
An observational study of HIV Infections and Acquired Immunodeficiency Syndrome, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2006to 26 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolled in at least one active NIH HIV/AIDS protocol.
- Age greater than or equal to 18 years.
- Willingness and capacity to provide informed consent.
- Self-identifying as Hispanic/Latino or African American/Black.
- Be HIV-positive.
- Willing to have comments recorded on audiotape.
Who cannot join
- Age less than 18 years.
- Self-identifying as other than Hispanic/Latino or African American/Black.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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:
Read more
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.
Read the 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.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Keywords
- Decision Making, Health Disparities, Hispanic, African-American, Clinical Trials, HIV Positive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, HIV Seropositivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study start26 Oct 2006
- Study completion26 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394004
- Sponsor's protocol ID
- 070015
- Other IDs
- 07-CC-0015
- Status last verified
- 26 Apr 2011
- First submitted
- 28 Oct 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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. doi: 10.1016/s0145-2134(99)00121-0.
PubMed 10660014Alderete 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. doi: 10.2105/ajph.90.4.608.
PubMed 10754977Allen 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. doi: 10.1089/088922201750236942.
PubMed 11429107
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Decision Making of Hispanics and African Americans With HIV/AIDS Participating in Clinical Trials
- ClinicalTrials.gov ID
- NCT00394004
- Acronym / sponsor ID
- 070015
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Keywords
- Decision Making, Health Disparities, Hispanic, African-American, Clinical Trials, HIV Positive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 26 Oct 2006
- Study completion
- 26 Apr 2011
- First posted
- 31 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (3 listed)
- Age less than 18 years.
- Self-identifying as other than Hispanic/Latino or African American/Black.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10660014Acevedo 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. doi: 10.1016/s0145-2134(99)00121-0.
- Background: PubMed 10754977Alderete 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. doi: 10.2105/ajph.90.4.608.
- Background: PubMed 11429107Allen 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. doi: 10.1089/088922201750236942.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Acquired Immunodeficiency Syndrome, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00394004, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.