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.

Study Overview

• Status: Completed
• Conditions: Clinician Attitudes About PrEP

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years
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.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults.	2 years

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Tanya Mullins, MD, Adolescent Trials Network

Publications and helpful links

Helpful Links

• ATN Website

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: ATN 111