Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials

HIV Infection Clinical Trial

Official title:

Improving Participation in AMC Clinical Trials (IMPACTS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946217
• Other study ID #: AMC-S006
• Secondary ID: NCI-2013-01152AM
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: August 16, 2016
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections
• Malignant Neoplasm
• Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York
United States	Montefiore-Einstein Cancer Center	Bronx	New York
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	UCLA Clinical AIDS Research and Education (CARE) Center	Los Angeles	California
United States	HIV Out-patient Clinic	New Orleans	Louisiana
United States	Interim LSU Public Hospital	New Orleans	Louisiana
United States	NO AIDS Clinic	New Orleans	Louisiana
United States	Laser Surgery Care	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Harborview Madison Clinic	Seattle	Washington
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), The EMMES Corporation, University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies	The proportion of individuals who are screened and agree to enroll in a clinical trial will be estimated with the binomial proportion and its 95% confidence interval.	Up to 2 weeks	No
Secondary	Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites	Chi-square tests will be used to compare the characteristics of those who enrolled in a clinical trial with those who did not with respect to sociodemographic characteristics, sexual orientation, and disease-type and design type.	Up to 2 weeks	No
Secondary	Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial	Chi-square tests will be used to compare the characteristics of those who enrolled in a clinical trial with those who did not with respect to sociodemographic characteristics, sexual orientation, and disease-type and design type.	Up to 2 weeks	No
Secondary	Perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial	For each study participant who did not enroll in a trial, the number of barriers in each category (views and attitudes, views of other people around them, financial burden and travel) will be computed. Summary statistics (mean, standard deviation [SD], median and interquartile range) will be used to estimate number of barriers in each category. Analyses of variance will be used to assess the associations of sociodemographic characteristics, sexual orientation, disease-type and design-type with the number of barriers in each category.	Up to 2 weeks	No
Secondary	Means by which volunteers are referred to a particular study	For study participants who enrolled in a clinical trial, the binomial proportion will be used to estimate the proportion who answered affirmatively to each of the six statements related to decision-making about clinical trials, and the individual reasons for participating in clinical trials. For each study participant who enrolled in a trial, the number of reasons cited for participation will be computed. Summary statistics mean, SD, median and interquartile range) will be used to estimate number of reasons cited for enrollment.	Up to 2 weeks	No