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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.
Study NCT00001717.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent
Official Title  Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent
Brief Summary

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.

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.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention 
MEDLINE PMIDs 5054323,   2379528,   8186281
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  225
Start Date  July 1998
Completion Date July 2000
Eligibility 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.

Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001717
Organization ID 980131
Secondary IDs †† 98-CC-0131
Study Sponsor  National Institutes of Health Clinical Center (CC)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date June 1999
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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