A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01865799

Enrollment

64186

Registered

2013-05-31

Start date

2013-04-22

Completion date

2018-01-22

Last updated

2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-exposure Prophylaxis for Prevention of HIV Infection

Keywords

FTC/TDF, PrEP, Truvada, Drug utilization

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy	Month 36

Secondary

Measure	Time frame	Description
Demographics and clinical characteristics of uninfected individuals who are prescribed FTC/TDF for a PrEP indication	Months 6, 12, 18, 24, 30, and 36	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.
Demographics of prescribers of FTC/TDF for a PrEP indication	Months 6, 12, 18, 24, 30, and 36	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.

Countries

United States

Outcome results