Completed

NCT Number: NCT01751659

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

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.

Completed

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Key information

Conditions

Clinician Attitudes About PrEP

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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 outcomes

Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults.

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

National Institute of Mental Health (NIMH)
National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Dec 18, 2012
Registry last updated: Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.