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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 |