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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000784
Collaborator
(none)
557
Enrollment
13
Locations
23
Duration (Months)
42.8
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    557 participants
    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
    Study Start Date :
    Oct 1, 1994
    Actual Primary Completion Date :
    Sep 1, 1996
    Actual Study Completion Date :
    Sep 1, 1996

    Arms and Interventions

    Arm Intervention/Treatment
    A

    Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      13 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Denver CPCRA / Denver Public Hlth Denver Colorado United States 80204
      2 Wilmington Hosp / Med Ctr of Delaware Wilmington Delaware United States 19899
      3 Veterans Administration Med Ctr / Regional AIDS Program Washington District of Columbia United States 20422
      4 AIDS Research Consortium of Atlanta Atlanta Georgia United States 30308
      5 AIDS Research Alliance - Chicago Chicago Illinois United States 60657
      6 Louisiana Comm AIDS Rsch Prog / Tulane Univ Med New Orleans Louisiana United States 70112
      7 Comprehensive AIDS Alliance of Detroit Detroit Michigan United States 48201
      8 Henry Ford Hosp Detroit Michigan United States 48202
      9 North Jersey Community Research Initiative Newark New Jersey United States 07103
      10 Bronx Lebanon Hosp Ctr Bronx New York United States 10456
      11 Harlem AIDS Treatment Group / Harlem Hosp Ctr New York New York United States 10037
      12 Portland Veterans Adm Med Ctr / Rsch & Education Grp Portland Oregon United States 97210
      13 Richmond AIDS Consortium Richmond Virginia United States 23298

      Sponsors and Collaborators

      • National Institute of Allergy and Infectious Diseases (NIAID)

      Investigators

      • Study Chair: Besch CL,
      • Study Chair: Morse EV,
      • Study Chair: Simon PM,

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      National Institute of Allergy and Infectious Diseases (NIAID)
      ClinicalTrials.gov Identifier:
      NCT00000784
      Other Study ID Numbers:
      • CPCRA 012
      • 11564
      First Posted:
      Aug 31, 2001
      Last Update Posted:
      Oct 1, 2013
      Last Verified:
      Sep 1, 2013
      Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
      Acquired Immunodeficiency Syndrome
      AIDS-Related Complex
      Additional relevant MeSH terms:
      Pneumonia, Pneumocystis

      Study Results

      No Results Posted as of Oct 1, 2013