HIV InfectionNCT01946217
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
An observational study of HIV Infection and Malignant Neoplasm, run by AIDS Malignancy Consortium at 14 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Malignant Neoplasm, Precancerous Condition
- What is being tested?
- questionnaire administration
- How many people
- 82 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected persons with a diagnosis of anal dysplasia or cancer who are offered informed consent on an AMC interventional clinical trial.
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Stroger Hospital of Cook County
Chicago, Illinois, 60612
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90024
Interim LSU Public Hospital
New Orleans, Louisiana, 70112
HIV Out-patient Clinic
New Orleans, Louisiana, 70119
NO AIDS Clinic
New Orleans, Louisiana, 70119
Laser Surgery Care
New York, New York, 10010
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Virginia Mason Medical Center
Seattle, Washington, 98101
Harborview Madison Clinic
Seattle, Washington, 98104
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461
Montefiore-Einstein Cancer Center
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Improving Participation in AMC Clinical Trials (IMPACTS)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- HIV Infection, Malignant Neoplasm, Precancerous Condition
- Being tested
- questionnaire administration
- Medical subject headings
- HIV Infections, Neoplasms, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaire administration) | Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation. Receives: Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Jack Burkhalter, Principal investigator, AIDS Associated Malignancies Clinical Trials Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946217
- Sponsor's protocol ID
- AMC-S006
- Other IDs
- NCI-2013-01152, AMC-S006, AMC-S006, U01CA121947
- Status last verified
- Aug 2016
- First submitted
- 17 Sep 2013
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Participation in AMC Clinical Trials (IMPACTS)
- ClinicalTrials.gov ID
- NCT01946217
- Acronym / sponsor ID
- AMC-S006
- Conditions
- HIV Infection, Malignant Neoplasm, Precancerous Condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire administration) | – | Other: questionnaire administrationParticipants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected persons with a diagnosis of anal dysplasia or cancer who are offered informed consent on an AMC interventional clinical trial.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Observational (questionnaire administration) |
Primary outcome
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.
4 secondary outcomes
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
Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial
Time frame: Up to 2 weeks
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
Means by which volunteers are referred to a particular study
Time frame: Up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Burkhalter principal investigator
AIDS Associated Malignancies Clinical Trials Consortium
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Malignant Neoplasm, run by AIDS Malignancy Consortium at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.