HIV Infections Clinical Trial
Official title:
A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
To examine, in patients enrolled in protocols CPCRA 006 and/or 007, the relationship between
patient compliance and demographic, psychosocial, and lifestyle characteristics and Health
Belief Model premises (i.e., patient's 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.
Patients who are enrolled on protocols CPCRA 006 and/or 007 are given a baseline
questionnaire to complete during the enrollment visit for the qualifying treatment protocol.
The survey concerns the patient's 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 patient's
perceptions of difficulties in protocol compliance requirements, clinic/office visits, and
health beliefs. The duration of patients on this study will be defined by the qualifying
protocol requirements.
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Observational Model: Case-Only, Time Perspective: Prospective
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