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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Foster City、California、アメリカ、94404
- Gilead Sciences, Inc.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy
時間枠：Month 36
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Month 36
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Demographics and clinical characteristics of uninfected individuals who are prescribed FTC/TDF for a PrEP indication
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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