Clinical trial NCT01751659: Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
Official title: Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinician Attitudes About PrEP
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2012-12-18
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Explore clinician attitudes and prescribing behaviors in MSM and heterosexually active adults
timeFrame: 2 years
measure: Identify factors associated with prescribing PrEP
timeFrame: 2 years
Secondary outcomes:
measure: Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults.
timeFrame: 2 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Adolescent Trials Network
name: Tanya Mullins, MD
role: STUDY_CHAIR
References: