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

NCT ID: NCT00001717

Last Updated: 2008-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-07-31

Study Completion Date

2000-07-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Eligibility Criteria

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Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role lead

Locations

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Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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. doi: 10.1002/cpt1972135part2771. No abstract available.

Reference Type BACKGROUND
PMID: 5054323 (View on PubMed)

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. doi: 10.1007/BF02336681.

Reference Type BACKGROUND
PMID: 2379528 (View on PubMed)

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. doi: 10.1080/09540129408258027.

Reference Type BACKGROUND
PMID: 8186281 (View on PubMed)

Other Identifiers

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98-CC-0131

Identifier Type: -

Identifier Source: secondary_id

980131

Identifier Type: -

Identifier Source: org_study_id

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