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

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	July 1998
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent
Official Title ^ICMJE	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 ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	Ayd FJ Jr, Calabresi P. Motivations and rewards for volunteering to be an experimental subject. Clin Pharmacol Ther. 1972 Sep-Oct;13(5):771-81. No abstract available. Bigorra J, Banos JE. Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials. Eur J Clin Pharmacol. 1990;38(5):443-6. Ross MW, Jeffords K, Gold J. Reasons for entry into and understanding of HIV/AIDS clinical trials: a preliminary study. AIDS Care. 1994;6(1):77-82.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	225
Completion Date	July 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001717
Responsible Party
Study ID Numbers ^ICMJE	980131, 98-CC-0131
Study Sponsor ^ICMJE	National Institutes of Health Clinical Center (CC)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	June 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP