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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT01751659
First received: December 14, 2012
Last updated: March 1, 2016
Last verified: March 2016
  Purpose

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
Clinician Attitudes About PrEP.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention

Resource links provided by NLM:


Further study details as provided by Westat:

Primary Outcome Measures:
  • Explore clinician attitudes and prescribing behaviors in MSM and heterosexually active adults [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: September 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751659

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Westat
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
Study Chair: Tanya Mullins, MD Adolescent Trials Network
  More Information

Additional Information:
Responsible Party: Westat
ClinicalTrials.gov Identifier: NCT01751659     History of Changes
Other Study ID Numbers: ATN 111 
Study First Received: December 14, 2012
Last Updated: March 1, 2016
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on August 24, 2016