NCT00394004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2006

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2011

Completed
Last Updated

July 2, 2017

Status Verified

April 26, 2011

First QC Date

October 28, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Decision MakingHealth DisparitiesHispanicAfrican-AmericanClinical TrialsHIV Positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 10660014BACKGROUND
  • 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. doi: 10.2105/ajph.90.4.608.

    PMID: 10754977BACKGROUND
  • 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. doi: 10.1089/088922201750236942.

    PMID: 11429107BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeHIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 28, 2006

First Posted

October 31, 2006

Study Start

October 26, 2006

Study Completion

April 26, 2011

Last Updated

July 2, 2017

Record last verified: 2011-04-26

Locations