We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Determining the Barriers and Motivations to Clinical Trial Participation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01937091
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : February 12, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Purpose: To comprehensively explore the barriers and motivators for participation in HIV clinical trials in a purposive sample of HIV positive patients receiving care at the UNC ID (Infectious Diseases) clinic Participants: HIV positive patients seen at the UNC ID Clinic. Participants will be purposively sampled based on gender, race and previous participation in HIV clinical trials. Blacks and patients who have never participated in clinical trials will be oversampled.

Procedures (methods): Cross-sectional study using in-depth semi-structured qualitative interviews to determine the barriers and motivators for participation in HIV clinical trials. Patient interviews will be audiotaped, transcribed verbatim and analyzed using Atlas.ti software to understand the barriers and motivators for participation in HIV clinical trials.


Condition or disease
HIV

Detailed Description:

Study Population: 48 HIV positive adult (at least 18 years of age) patients receiving care at the UNC ID Clinic will be enrolled in the study. Purposive sampling by race, gender and previous participation in HIV clinical trials will be used to ensure adequate representation in each category. Participation in a clinical trial will be defined as having participated in a trial of highly active antiretroviral therapy (HAART) for duration of > 48 weeks. Non-trial participation will be defined as having been offered the opportunity to participate in a clinical trial but have never participated in any clinical trial or participated in a trial that included a one-time sample collection with no follow up visits.

STUDY METHODS

Questionnaire: The questionnaire consists of open-ended questions to be administered to participants. The questionnaire items were composed by reviewing related studies. Two versions of the questionnaire will be administered, one for participants with a history of participation in clinical trials and one for participants who were approached but have never been in a clinical trial (See Appendix 1.) The questionnaire will be revised after pre-testing to incorporate changes before it will be administered to all 48 participants.

Interview: The interview will be conducted at the UNC ID clinic by one research assistant. The interview will take approximately 45 minutes and will be audiotaped.


Study Design

Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Determining the Barriers and Motivations to Clinical Trial Participation
Study Start Date : August 2013
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Participants in trials
Participated in a trial of HAART for duration of > 48 weeks.
Non-participants in trials
Never participated in clinical trials of HAART Must have been offered participation in a clinical trial and declined


Outcome Measures

Primary Outcome Measures :
  1. Reasons why people choose to or not to participate in HIV Clinical Trials based on questionnaire responses [ Time Frame: Administered immediately following provision of informed consent ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-positive adults, > 18 years, who receive care at the UNC ID clinic and who have previously been approached for (or offered) participation in a clinical trial.
Criteria

Inclusion Criteria:

  • HIV-positive adults,
  • at least 18 years of age,
  • receiving care at the UNC ID clinic,
  • have previously been approached for (or offered) participation in a clinical trial.

Exclusion Criteria:

  • Non native English speaking patients
  • Unable to provide informed consent
  • Have never been offered participation in a clinical trial
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937091


Locations
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Janssen Services, LLC
Investigators
Principal Investigator: Prema Menezes, Ph. D, PA-C University of North Carolina, Chapel Hill
More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01937091     History of Changes
Other Study ID Numbers: 13-1948
IGHID 1303
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: April 2014

Keywords provided by University of North Carolina, Chapel Hill:
HIV
clinical trials