Clinician Attitudes About PrEPNCT01751659
Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
An observational study of Clinician Attitudes About PrEP, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clinician Attitudes About PrEP
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read more
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.
- Conditions
- Clinician Attitudes About PrEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinician Attitudes About PrEPStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Tanya Mullins, MD, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751659
- Sponsor's protocol ID
- ATN 111
- Status last verified
- Nov 2016
- First submitted
- 14 Dec 2012
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
- ClinicalTrials.gov ID
- NCT01751659
- Acronym / sponsor ID
- ATN 111
- Conditions
- Clinician Attitudes About PrEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- ATN websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Mullins, MD study chair
Adolescent Trials Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinician Attitudes About PrEP, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore clinician attitudes and prescribing behaviors in MSM and heterosexually active adults (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.