Determining the Barriers and Motivations to Clinical Trial Participation

February 10, 2015 updated by: University of North Carolina, Chapel Hill

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Administered immediately following provision of informed consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Janssen Services, LLC

Investigators

  • Principal Investigator: Prema Menezes, Ph. D, PA-C, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (Estimate)

September 9, 2013

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-1948
  • IGHID 1303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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