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Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent

This study has been completed.

Sponsored by: National Institutes of Health Clinical Center (CC)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001717
  Purpose

This protocol seeks to better understand the various factors which influence an HIV infected individual's decision to participate in clinical research, and especially how the offer of payment influences the decision to participate and understanding of the risks, benefits and purpose of the research. Subjects will be HIV infected individuals participating in or being screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and NCI. Willing subjects will be recruited from studies that offer payment and comparable studies that do not pay. The primary methodology is an interview via a survey schedule. Use of the interview schedule will be preceded by a focus group of about 7-10 individuals and pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect to motivations, understanding, willingness to withdraw, and sociodemographics.


Condition
HIV Infections

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent

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

Estimated Enrollment:   225
Study Start Date:   July 1998
Estimated Study Completion Date:   July 2000

Detailed Description:

This protocol seeks to better understand the various factors which influence an HIV infected individual's decision to participate in clinical research, and especially how the offer of payment influences the decision to participate and understanding of the risks, benefits and purpose of the research. Subjects will be HIV infected individuals participating in or being screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and NCI. Willing subjects will be recruited from studies that offer payment and comparable studies that do not pay. The primary methodology is an interview via a survey schedule. Use of the interview schedule will be preceded by a focus group of about 7-10 individuals and pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect to motivations, understanding, willingness to withdraw, and sociodemographics.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Those HIV seropositive subjects participating in or being screened for participation in selected NIAID or NCI intramural HIV studies will be eligible for participation in this study.

Eligible subjects are those willing and able to provide their own informed consent.

No subjects that are unable to speak English or are unable or unwilling to communicate with investigators for any reason.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001717

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information

Publications:

Study ID Numbers:   980131, 98-CC-0131
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001717
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Compensation  
Motivations  
Volunteers  
HIV  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on August 28, 2008




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