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

27 februari 2017 uppdaterad av: University of North Carolina, Chapel Hill

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.

Studieöversikt

Status

Avslutad

Betingelser

Clinician Attitudes About PrEP

Studietyp

Observationell

Inskrivning (Faktisk)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- Ohio
  - Cincinnati, Ohio, Förenta staterna, 45229
    - Cincinnati Children's Hospital Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn
Vuxen
Äldre vuxen

Tar emot friska volontärer

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Explore clinician attitudes and prescribing behaviors in MSM and heterosexually active adults Tidsram: 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	2 years
Identify factors associated with prescribing PrEP Tidsram: 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.	2 years

Sekundära resultatmått

Resultatmått	Tidsram
Explore clinician attitudes toward the use of PrEP in potential target populations other than MSM and heterosexually active adults. Tidsram: 2 years	2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of North Carolina, Chapel Hill

Samarbetspartners

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Utredare

Studiestol: Tanya Mullins, MD, Adolescent Trials Network

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

ATN Website

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2012

Primärt slutförande (Faktisk)

1 april 2014

Avslutad studie (Faktisk)