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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Participation in AMC Clinical Trials (IMPACTS)

Conditions
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HIV Infection, Malignant Neoplasm, Precancerous Condition

Intervention / Treatment
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* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire administration)<br>Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation. | Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |