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



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

For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type:
  Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 700

Location and Contact Information:

Overall Study Official:
BeschCL,  Study Chair, 

Richmond AIDS Consortium
Richmond,  Virginia,  23298
United States
 

AIDS Research Alliance - Chicago
Chicago,  Illinois,  60657
United States
 

Denver CPCRA / Denver Public Hlth
Denver,  Colorado,  802044507
United States
 

North Jersey Community Research Initiative
Newark,  New Jersey,  071032842
United States
 

Henry Ford Hosp
Detroit,  Michigan,  48202
United States
 

Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C.,  District of Columbia,  20422
United States
 

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

Wilmington Hosp / Med Ctr of Delaware
Wilmington,  Delaware,  19899
United States
 

Bronx Lebanon Hosp Ctr
Bronx,  New York,  10456
United States
 

Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland,  Oregon,  972109951
United States
 

Comprehensive AIDS Alliance of Detroit
Detroit,  Michigan,  48201
United States
 

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans,  Louisiana,  70112
United States
 


Additional Information:
Study ID Numbers:
  CPCRA 012; 
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000784

Other Hiv Infections Studies:
1. Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children.

2. A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides

3. A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS

4. A Treatment IND for 566C80 Therapy of Pneumocystis carinii Pneumonia

5. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole

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

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