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A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000784
  Purpose

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.


Condition
Pneumonia, Pneumocystis Carinii
HIV Infections

MedlinePlus related topics:   AIDS    Pneumonia   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   557
Study Start Date:   October 1994
Primary Completion Date:   June 2005 (Final data collection date for primary outcome measure)

Groups/Cohorts
A
Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006

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 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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006


Criteria

Patients must meet the following 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000784

Locations
United States, Colorado
Denver CPCRA / Denver Public Hlth    
      Denver, Colorado, United States, 802044507
United States, Delaware
Wilmington Hosp / Med Ctr of Delaware    
      Wilmington, Delaware, United States, 19899
United States, District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program    
      Washington, District of Columbia, United States, 20422
United States, Georgia
AIDS Research Consortium of Atlanta    
      Atlanta, Georgia, United States, 30308
United States, Illinois
AIDS Research Alliance - Chicago    
      Chicago, Illinois, United States, 60657
United States, Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med    
      New Orleans, Louisiana, United States, 70112
United States, Michigan
Henry Ford Hosp    
      Detroit, Michigan, United States, 48202
Comprehensive AIDS Alliance of Detroit    
      Detroit, Michigan, United States, 48201
United States, New Jersey
North Jersey Community Research Initiative    
      Newark, New Jersey, United States, 071032842
United States, New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr    
      New York, New York, United States, 10037
Bronx Lebanon Hosp Ctr    
      Bronx, New York, United States, 10456
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp    
      Portland, Oregon, United States, 972109951
United States, Virginia
Richmond AIDS Consortium    
      Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Investigators
Study Chair:     Besch CL    
Study Chair:     Morse EV    
Study Chair:     Simon PM    
  More Information


Publications:
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
 

Responsible Party:   DAIDS ( Rona Siskind )
Study ID Numbers:   CPCRA 012
First Received:   November 2, 1999
Last Updated:   September 25, 2008
ClinicalTrials.gov Identifier:   NCT00000784
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Retroviridae Infections
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 29, 2008




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