HIV Clinical Trial - Determining the Barriers & Motivations to Clinical

Status Completed

Clinical Trial 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.

Clinical Trial 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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01937091
Study type	Observational
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	N/A
Start date	August 2013
Completion date	September 2014

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Determining the Barriers and Motivations to Clinical Trial Participation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms