A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
NCT ID: NCT00000784
Last Updated: 2013-10-01
Study Results
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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COMPLETED
557 participants
OBSERVATIONAL
1994-10-31
1996-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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A
Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* New enrollment on CPCRA 006 or CPCRA 007.
* Life expectancy of at least 6 months.
* Willing and able, in clinician's opinion, to comply with treatment and clinical management.
* Able to read and write English or Spanish.
* Consent of parent of guardian for patients under 18 years.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Besch CL
Role: STUDY_CHAIR
Morse EV
Role: STUDY_CHAIR
Simon PM
Role: STUDY_CHAIR
Locations
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Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
Countries
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References
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Simon PM, Morse EV, Besch L. Barriers to compliance among women co-enrolled in a PCP prophylaxis and compliance protocol. HIV Infect Women Conf. 1995 Feb 22-24:P109
Other Identifiers
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11564
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 012
Identifier Type: -
Identifier Source: org_study_id