Determining the Barriers and Motivations to Clinical Trial Participation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01937091
First received: August 29, 2013
Last updated: April 2, 2014
Last verified: April 2014

August 29, 2013
April 2, 2014
August 2013
August 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01937091 on ClinicalTrials.gov Archive Site
Not Provided
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Determining the Barriers and Motivations to Clinical Trial Participation
Determining the Barriers and Motivations to Clinical Trial Participation

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

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.

HIV
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01937091
13-1948, IGHID 1303
No
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Janssen Services, LLC
Principal Investigator: Prema Menezes, Ph. D, PA-C University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP