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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pre-exposure Prophylaxis for Prevention of HIV Infection

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FTC/TDF for PrEP<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FTC/TDF, PrEP, Truvada, Drug utilization