Nctid:
NCT00000784
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D011020", "term"=>"Pneumonia, Pneumocystis"}], "ancestors"=>[{"id"=>"D011014", "term"=>"Pneumonia"}, {"id"=>"D012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D008172", "term"=>"Lung Diseases, Fungal"}, {"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D016720", "term"=>"Pneumocystis Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M13910", "name"=>"Pneumonia, Pneumocystis", "asFound"=>"Pneumonia, Pneumocystis", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M11169", "name"=>"Lung Diseases, Fungal", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M19082", "name"=>"Pneumocystis Infections", "relevance"=>"LOW"}, {"id"=>"T4598", "name"=>"Pneumocystis Jirovecii Pneumonia", "asFound"=>"Pneumonia, Pneumocystis carinii", "relevance"=>"HIGH"}, {"id"=>"T4599", "name"=>"Pneumocystosis", "asFound"=>"Pneumonia, Pneumocystis carinii", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>557}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-09", "completionDateStruct"=>{"date"=>"1996-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-09-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2013-10-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1996-09", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Acquired Immunodeficiency Syndrome", "AIDS-Related Complex"], "conditions"=>["Pneumonia, Pneumocystis Carinii", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"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"}]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nPatient 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.", "detailedDescription"=>"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.\n\nPatients 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Patients must meet the following criteria:\n\n* New enrollment on CPCRA 006 or CPCRA 007.\n* Life expectancy of at least 6 months.\n* Willing and able, in clinician's opinion, to comply with treatment and clinical management.\n* Able to read and write English or Spanish.\n* Consent of parent of guardian for patients under 18 years."}, "identificationModule"=>{"nctId"=>"NCT00000784", "briefTitle"=>"A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols", "orgStudyIdInfo"=>{"id"=>"CPCRA 012"}, "secondaryIdInfos"=>[{"id"=>"11564", "type"=>"REGISTRY", "domain"=>"DAIDS ES"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"A", "description"=>"Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"80204", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Denver CPCRA / Denver Public Hlth", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"19899", "city"=>"Wilmington", "state"=>"Delaware", "country"=>"United States", "facility"=>"Wilmington Hosp / Med Ctr of Delaware", "geoPoint"=>{"lat"=>39.74595, "lon"=>-75.54659}}, {"zip"=>"20422", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Veterans Administration Med Ctr / Regional AIDS Program", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60657", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"AIDS Research Alliance - Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Louisiana Comm AIDS Rsch Prog / Tulane Univ Med", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Comprehensive AIDS Alliance of Detroit", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"48202", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Henry Ford Hosp", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"07103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"North Jersey Community Research Initiative", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"10456", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx Lebanon Hosp Ctr", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem AIDS Treatment Group / Harlem Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"23298", "city"=>"Richmond", "state"=>"Virginia", "country"=>"United States", "facility"=>"Richmond AIDS Consortium", "geoPoint"=>{"lat"=>37.55376, "lon"=>-77.46026}}], "overallOfficials"=>[{"name"=>"Besch CL", "role"=>"STUDY_CHAIR"}, {"name"=>"Morse EV", "role"=>"STUDY_CHAIR"}, {"name"=>"Simon PM", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
