A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
Data Collection
Collected from today forward - ProspectiveBlood-Borne Infections+23
+ Urogenital Diseases
+ Genital Diseases
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: October 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.557 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Denver CPCRA / Denver Public Hlth
Denver, United StatesOpen Denver CPCRA / Denver Public Hlth in Google MapsWilmington Hosp / Med Ctr of Delaware
Wilmington, United StatesVeterans Administration Med Ctr / Regional AIDS Program
Washington D.C., United StatesAIDS Research Consortium of Atlanta
Atlanta, United States