NCT01937091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 12, 2015

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

August 29, 2013

Last Update Submit

February 10, 2015

Conditions

HIV

Keywords

HIVclinical trials

Outcome Measures

Primary Outcomes (1)

  • Reasons why people choose to or not to participate in HIV Clinical Trials based on questionnaire responses

    Administered immediately following provision of informed consent

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

  • Prema Menezes, Ph. D, PA-C

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 9, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 12, 2015

Record last verified: 2014-04

Locations

US(1)