Clinical trial NCT01865799: A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
Official title: A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-exposure Prophylaxis for Prevention of HIV Infection
Keywords: FTC/TDF
PrEP
Truvada
Drug utilization
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 64186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy
timeFrame: Month 36
Secondary outcomes:
measure: Demographics and clinical characteristics of uninfected individuals who are prescribed FTC/TDF for a PrEP indication
timeFrame: Months 6, 12, 18, 24, 30, and 36
measure: Demographics of prescribers of FTC/TDF for a PrEP indication
timeFrame: Months 6, 12, 18, 24, 30, and 36
Other outcomes:
Locations:
city: Foster City
country: United States
facility: Gilead Sciences, Inc.
state: California
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: