Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000784
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
1999-11-02
Brief Title:
A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To examine in patients enrolled in protocols CPCRA 006 andor 007 the relationship between patient compliance and demographic psychosocial and lifestyle characteristics and Health Belief Model premises ie patients perception of susceptibility to and severity of disease and perception of benefits and barriers to a particular treatment in order to design more effective intervention protocols
Patient noncompliance can influence the statistical findings of a clinical study possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance
Patient noncompliance can influence the statistical findings of a clinical study possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance
Detailed Description:
Patient noncompliance can influence the statistical findings of a clinical study possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance
Patients who are enrolled on protocols CPCRA 006 andor 007 are given a baseline questionnaire to complete during the enrollment visit for the qualifying treatment protocol The survey concerns the patients work primary language support systems residence status perception of disease and treatments and substance use At 4-month follow-up visits patients are asked to complete a self-report questionnaire which assesses the patients perceptions of difficulties in protocol compliance requirements clinicoffice visits and health beliefs The duration of patients on this study will be defined by the qualifying protocol requirements
Patients who are enrolled on protocols CPCRA 006 andor 007 are given a baseline questionnaire to complete during the enrollment visit for the qualifying treatment protocol The survey concerns the patients work primary language support systems residence status perception of disease and treatments and substance use At 4-month follow-up visits patients are asked to complete a self-report questionnaire which assesses the patients perceptions of difficulties in protocol compliance requirements clinicoffice visits and health beliefs The duration of patients on this study will be defined by the qualifying protocol requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11564 | REGISTRY | DAIDS ES | None |