Determining the Barriers and Motivations to Clinical Trial Participation

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.

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