A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
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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 |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Study Type: | Observational |
Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
Official Title: | A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols |
Enrollment: | 557 |
Study Start Date: | October 1994 |
Study Completion Date: | September 1996 |
Primary Completion Date: | September 1996 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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A
Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006
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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.
![](https://webarchive.library.unt.edu/web/20130315210052im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006
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.
![](https://webarchive.library.unt.edu/web/20130315210052im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 | |
Bronx Lebanon Hosp Ctr | |
Bronx, New York, United States, 10456 | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
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 |
Study Chair: | Besch CL | |
Study Chair: | Morse EV | |
Study Chair: | Simon PM |
![](https://webarchive.library.unt.edu/web/20130315210052im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Responsible Party: | Rona Siskind, DAIDS |
ClinicalTrials.gov Identifier: | NCT00000784 History of Changes |
Other Study ID Numbers: | CPCRA 012 |
Study First Received: | November 2, 1999 |
Last Updated: | December 17, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections |
ClinicalTrials.gov processed this record on March 14, 2013