Improving Participation in AMC Clinical Trials (IMPACTS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 82
- Locations
- 14
- Primary Endpoint
- Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites(Up to 2 weeks)
- Means by which volunteers are referred to a particular study(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)