Clinical trial NCT01946217: Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
Official title: Improving Participation in AMC Clinical Trials (IMPACTS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Malignant Neoplasm
Precancerous Condition
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: The Emmes Company, LLC
name: University of Arkansas
First posted: 2013-09-19
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected persons with a diagnosis of anal dysplasia or cancer who are offered informed consent on an AMC interventional clinical trial.

Brief summary: This pilot research trial studies factors affecting patient participation in Acquired Immune Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials. Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.

Detailed description: PRIMARY OBJECTIVES:

I. To identify participant-level factors affecting recruitment of potentially eligible participants in AIDS Malignancy Clinical Trials Consortium (AMC) studies at core and affiliated sites.

SECONDARY OBJECTIVES:

I. To describe the socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites.

II. To characterize socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial.

III. To identify the perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial.

IV. To better understand how potential study volunteers learn about AMC clinical trials and by what means are they referred to a particular study.

OUTLINE:

Participants complete the Improving Participation in AMC Clinical Trials (IMPACTS) survey comprising questions about socio-demographic information and clinical trial participation.

Eligibility criteria: Inclusion Criteria:

* HIV-infected participants
* Cancer or anal dysplasia diagnosis
* Offered informed consent on an AMC interventional clinical trial
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites
timeFrame: Up to 2 weeks
measure: Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial
timeFrame: Up to 2 weeks
measure: Perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial
timeFrame: Up to 2 weeks
measure: Means by which volunteers are referred to a particular study
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Clinical AIDS Research and Education (CARE) Center
state: California
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Interim LSU Public Hospital
state: Louisiana
city: New Orleans
country: United States
facility: HIV Out-patient Clinic
state: Louisiana
city: New Orleans
country: United States
facility: NO AIDS Clinic
state: Louisiana
city: Bronx
country: United States
facility: Albert Einstein Cancer Center at Albert Einstein College of Medicine
state: New York
city: Bronx
country: United States
facility: Montefiore-Einstein Cancer Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Laser Surgery Care
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Harborview Madison Clinic
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: AIDS Associated Malignancies Clinical Trials Consortium
name: Jack Burkhalter
role: PRINCIPAL_INVESTIGATOR
References: