Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
This study is currently recruiting participants.
Verified October 2012 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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: NA
Last verified: October 2012
History: No changes posted
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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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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 ]
| Estimated Enrollment: | 75 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
Phase I
|
Phase II
|
Phase III
|
Eligibility| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751659
Contacts
| Contact: Sarah Thornton, BS | (240) 453-5649 | sarahthornton@westat.com |
Locations
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Tanya Mullins, MD 513-636-2245 tanya.mullins@cchmc.org | |
| Principal Investigator: Tanya Mullins, MD | |
Sponsors and Collaborators
Investigators
| Study Chair: | Tanya Mullins, MD | Adolescent Trials Network |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT01751659 History of Changes |
| Other Study ID Numbers: | ATN 111 |
| Study First Received: | December 14, 2012 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on March 14, 2013
