Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Bacterial Infections and Mycoses
+7

+ Infections
+ Lung Diseases
Over 13 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: October 1994
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 1994Actual 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.

Official TitleA Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols 
NCT00000784
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
557 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.

Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bacterial Infections and Mycoses
Infections
Lung Diseases
Lung Diseases, Fungal
Mycoses
Pneumonia
Pneumonia, Pneumocystis
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumocystis Infections
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
Suspended
Denver CPCRA / Denver Public HlthDenver, United StatesSee the location
Suspended
Wilmington Hosp / Med Ctr of DelawareWilmington, United States
Suspended
Veterans Administration Med Ctr / Regional AIDS ProgramWashington, United States
Suspended
AIDS Research Consortium of AtlantaAtlanta, United States
Completed13 Study Centers