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NCT Number: NCT01946217

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

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Malignant Neoplasm Neoplasms Precancerous Condition Precancerous Conditions RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies

    Time frame: Up to 2 weeks

    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.

Secondary outcomes

  1. Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites

    Time frame: Up to 2 weeks

    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.

  2. Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial

    Time frame: Up to 2 weeks

    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.

  3. Perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial

    Time frame: Up to 2 weeks

    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.

  4. Means by which volunteers are referred to a particular study

    Time frame: Up to 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

AIDS Malignancy Consortium

Network

Collaborators

  • National Cancer Institute (NCI)
  • The Emmes Company, LLC
  • University of Arkansas

Registry information

Official study title

Improving Participation in AMC Clinical Trials (IMPACTS)

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2013
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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