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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001717
• Other study ID #: 980131
• Secondary ID: 98-CC-0131
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: July 1998
• Est. completion date: July 2000

Study information

• Verified date: June 1999
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: July 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Warren G. Magnuson Clinical Center (CC)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Bigorra J, Baños 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. — View Citation

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. — View Citation