Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
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ClinicalTrials.gov Identifier: NCT01751659 |
Recruitment Status
:
Completed
First Posted
: December 18, 2012
Last Update Posted
: February 28, 2017
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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 or disease |
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Clinician Attitudes About PrEP |
Study Type : | Observational |
Actual Enrollment : | 62 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Group/Cohort |
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Phase I
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Phase II
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Phase III
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- 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.
- Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults. [ Time Frame: 2 years ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751659
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
Study Chair: | Tanya Mullins, MD | Adolescent Trials Network |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01751659 History of Changes |
Other Study ID Numbers: |
ATN 111 |
First Posted: | December 18, 2012 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | November 2016 |