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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01751659
First received: December 14, 2012
Last updated: May 8, 2014
Last verified: May 2014

December 14, 2012
May 8, 2014
September 2012
September 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01751659 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Clinician Attitudes About PrEP.
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01751659
ATN 111
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Tanya Mullins, MD Adolescent Trials Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP