Clinical trial NCT00000784: A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
Official title: A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 557
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006

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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver CPCRA / Denver Public Hlth
state: Colorado
city: Wilmington
country: United States
facility: Wilmington Hosp / Med Ctr of Delaware
state: Delaware
city: Washington
country: United States
facility: Veterans Administration Med Ctr / Regional AIDS Program
state: District of Columbia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: New Orleans
country: United States
facility: Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
state: Louisiana
city: Detroit
country: United States
facility: Comprehensive AIDS Alliance of Detroit
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: Bronx
country: United States
facility: Bronx Lebanon Hosp Ctr
state: New York
city: New York
country: United States
facility: Harlem AIDS Treatment Group / Harlem Hosp Ctr
state: New York
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Richmond
country: United States
facility: Richmond AIDS Consortium
state: Virginia
Study officials:
name: Besch CL
role: STUDY_CHAIR
name: Morse EV
role: STUDY_CHAIR
name: Simon PM
role: STUDY_CHAIR
References:
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