Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
Improving Participation in AMC Clinical Trials (IMPACTS)
3 other identifiers
observational
82
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2013
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedAugust 18, 2016
August 1, 2016
2 years
September 17, 2013
August 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites
Up to 2 weeks
Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial
Up to 2 weeks
Perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial
Up to 2 weeks
Means by which volunteers are referred to a particular study
Up to 2 weeks
Study Arms (1)
Observational (questionnaire administration)
Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation.
Interventions
Eligibility Criteria
HIV-infected persons with a diagnosis of anal dysplasia or cancer who are offered informed consent on an AMC interventional clinical trial.
You may qualify if:
- 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
You may not qualify if:
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AIDS Malignancy Consortiumlead
- National Cancer Institute (NCI)collaborator
- The Emmes Company, LLCcollaborator
- University of Arkansascollaborator
Study Sites (14)
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90024, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Interim LSU Public Hospital
New Orleans, Louisiana, 70112, United States
HIV Out-patient Clinic
New Orleans, Louisiana, 70119, United States
NO AIDS Clinic
New Orleans, Louisiana, 70119, United States
Laser Surgery Care
New York, New York, 10010, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Montefiore-Einstein Cancer Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Harborview Madison Clinic
Seattle, Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jack Burkhalter
AIDS Associated Malignancies Clinical Trials Consortium
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 19, 2013
Study Start
September 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
August 18, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share