A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | April 22, 2013 |
| End Date: | January 22, 2018 |
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.
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.
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.
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