A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
This is a prospective, 3-year observational study to describe drug utilization in uninfected individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication.
An electronic source of pharmacy/medical encounter information will be used to assess the demographics and other characteristics of the subjects prescribed FTC/TDF or its components in a prospective fashion. The data provider will supply all the de-identified information regarding each visit/interaction that the subject has had with the health system and all the diagnoses and medications that the UI has had prospectively and retrospectively for the length of time captured by the source selected.
200 physicians who prescribe FTC/TDF for a PrEP indication will be sampled from the same source.
Studienübersicht
Status
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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California
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Foster City, California, Vereinigte Staaten, 94404
- Gilead Sciences, Inc.
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
This prospective case series is composed of every subject in the database that is exposed to FTC/TDF or its components for any indication.
Additionally, 200 physicians who prescribe FTC/TDF for a PrEP indication will be randomly sampled from the same source.
Beschreibung
Key Inclusion Criteria:
- Patient/ Uninfected Individual
- Adult (any sex/gender, including transgender) ≥18 years old
- Taking FTC/TDF prescribed for any indication or its components Prescriber
- Possesses an active health care professional license in good standing, with the authority to prescribe prescription medications, either independently (eg, physician) or under legally permissible arrangements for prescribing under physician supervision (eg, Nurse Practitioner or Physician Assistant)
- Practice site is within the USA
- Having prescribed FTC/TDF for a PrEP indication
Key Exclusion Criteria:
- There are no exclusion criteria for individuals or prescribers
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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FTC/TDF for PrEP
This prospective case series is composed of every subject in a database containing de-identified patient-level data from all healthcare channels in the US, of individuals that are exposed to FTC/TDF or its components for any indication.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy
Zeitfenster: Month 36
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Month 36
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Demographics and clinical characteristics of uninfected individuals who are prescribed FTC/TDF for a PrEP indication
Zeitfenster: Months 6, 12, 18, 24, 30, and 36
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Demographics (including age, gender and if available, race and ethnicity) and clinical characteristics (including diagnoses, procedures, and laboratory test results) will be summarized by 1) exposure group and 2) overall using descriptive statistics (sample size, mean, standard deviation, median, interquartile range, minimum and maximum) for continuous data, and by the number of participants for categorical data; age will be calculated as age in years at exposure.
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Months 6, 12, 18, 24, 30, and 36
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Demographics of prescribers of FTC/TDF for a PrEP indication
Zeitfenster: Months 6, 12, 18, 24, 30, and 36
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Demographics (including gender, medical degree, medical specialty, number of years in medical practice, and setting of care) of prescribers of FTC/TDF for a PrEP indication will be summarized using descriptive statistics (sample size, mean, standard deviation, median, interquartile range, minimum and maximum) for continuous data and by the number prescribers for categorical data.
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Months 6, 12, 18, 24, 30, and 36
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- GS-US-276-0105
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