CClinicalTrials.gg
CompletedNCT01751659Updated Feb 28, 2017

Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention

An observational study in Clinician Attitudes About PrEP, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by University of North Carolina, Chapel Hill · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
62
Sex
All
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Study summary

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.

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Conditions studied

  • Clinician Attitudes About PrEP
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In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
62 participants (actual)

Groups and cohorts

  • Phase I

    * Semi-structured face-to-face or telephone interviews of 10 ATN-affiliated clinicians. * The total duration of Phase 1 is expected to last approximately nine months, including data analysis.

  • Phase II

    * Development of a new theory-based survey instrument and cognitive interview testing of this survey with approximately five clinicians (of those who participated in Phase 1). * The total duration of Phase 2 is expected to last approximately three months, including qualitative analysis of the interviews and modification of the survey.

  • Phase III

    * Administration of the newly developed survey to approximately 60 ATN-affiliated clinicians. * The total duration of Phase 3 will last approximately six to nine months.

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What researchers measure

Primary outcomes

  1. Explore clinician attitudes and prescribing behaviors in MSM and heterosexually active adults

    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

    Time frame: 2 years

  2. Identify factors associated with prescribing PrEP

    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.

    Time frame: 2 years

Secondary outcomes

  1. 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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Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
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References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01751659
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Dec 18, 2012
Start date
Sep 2012
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Feb 28, 2017

Study contacts

Tanya Mullins, MD
study chair · Adolescent Trials Network

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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