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Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01751659
First received: December 14, 2012
Last updated: February 27, 2017
Last verified: November 2016
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Purpose
This is a three phase study designed to examine clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary Human Immunodeficiency Virus (HIV) prevention strategy, and to identify knowledge-related and attitudinal factors associated with these behaviors. Each phase consists of the following:
Phase 1: Semi-structured face-to-face or telephone interviews of ATN-affiliated clinicians. Approximately 10 clinicians will be interviewed.
Phase 2: Development of a new theory-based survey instrument and cognitive interview testing of this survey. Approximately five clinicians (of those who participated in Phase 1) will be interviewed.
Phase 3: Administration of the newly developed survey to ATN-affiliated clinicians. Approximately 60 clinicians will be interviewed.
| Condition |
|---|
| Clinician Attitudes About PrEP |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Explore clinician attitudes and prescribing behaviors in MSM and heterosexually active adults [ Time Frame: 2 years ]Explore clinician attitudes and prescribing behaviors with regard to the use of PrEP in men who have sex with men (MSM) and heterosexually active adults as described in the current CDC guidelines, as well as in MSM and heterosexually active adolescents, who are not specifically covered by the guidelines
- Identify factors associated with prescribing PrEP [ Time Frame: 2 years ]Identify factors associated with prescribing PrEP, in a sample of clinicians who provide care to HIV-infected adolescents alone OR to HIV-infected and HIV-uninfected adolescents.
Secondary Outcome Measures:
- Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults. [ Time Frame: 2 years ]
| Enrollment: | 62 |
| Study Start Date: | September 2012 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
Phase I
|
Phase II
|
Phase III
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
ATN-affiliated clinicians (including physicians, nurse practitioners, and physician assistants) who EITHER 1) provide care for HIV-infected and HIV-uninfected adolescents OR 2) provide care to HIV-infected adolescents only.
Criteria
Inclusion Criteria:
- Clinicians (including physicians, nurse practitioners, and physician assistants) that EITHER: Provide primary HIV care for HIV-infected and primary care for HIV-uninfected adolescents; OR Provide primary HIV care to HIV-infected adolescents only;
- Provides services to adolescents and young adults at ATN sites or one of their community partners;
- Ability to understand spoken English; and
- For Phase 2 only: prior participation in Phase 1.
Exclusion Criteria:
- Intoxicated or under the influence of alcohol or other substances at the time of consent;
- Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) and in the opinion of the protocol chair would interfere with the ability to give true informed consent; and
- For Phase 3 only: prior participation in Phase 1 or 2 of this study.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751659
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751659
Locations
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
| Study Chair: | Tanya Mullins, MD | Adolescent Trials Network |
More Information
Additional Information:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01751659 History of Changes |
| Other Study ID Numbers: |
ATN 111 |
| Study First Received: | December 14, 2012 |
| Last Updated: | February 27, 2017 |
ClinicalTrials.gov processed this record on June 28, 2017