PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI) (PEPPI)
2026年7月2日 更新者：Jenny Newlon、EMPOWERX INC
Impact of PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI)
The goal of this clinical trial is to learn if use of the PEPPI software can improve pharmacist-provided HIV prevention (PEP/PrEP) services. The main questions it aims to answer are:
- Does the PEPPI software make it easier for pharmacists to provide PEP/PrEP services in their pharmacy?
- Does the PEPPI software make it easier for patients to access PEP/PrEP?
Researchers will compare pharmacists' implementation and patients' access when using the PEPPI software and when not using the PEPPI software to see if the software improves implementation and access.
Participants will include pharmacists and patients. Pharmacists will be asked to provide PEP/PrEP services as normal while using the PEPPI software. Patients will be asked to receive PEP/PrEP services from a pharmacist as normal, while using the PEPPI software.
調査の概要
研究の種類
介入
入学 (推定)
195
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sally Rafie, PharmD
- メール：Sally@birthcontrolpharmacist.com
研究連絡先のバックアップ
- 名前：Jenny L Newlon, PharmD, PhD
- 電話番号：8584120984
- メール：jenny@birthcontrolpharmacist.com
研究場所
-
-
California
-
Del Mar、California、アメリカ、92014
- 募集
- EmpoweRx, Inc
-
コンタクト：
- Sally Rafie, PharmD
- 電話番号：8584120984
- メール：sally@birthcontrolpharmacist.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
PHARMACIST Participants
Inclusion Criteria:
- 18 years of age or older
- Provide, or willing to provide, PEP/PrEP services in a participating pharmacy
- Use the PEPPI software to provide birth control services
Exclusion Criteria:
- None
PATIENT Participants
Inclusion Criteria:
- 18 years of age or older
- Seek PEP or PrEP services at a participating pharmacy
- Use the PEPPI software to receive PEP/PrEP services at a participating pharmacy
Exclusion Criteria:
- NONE
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：PEPPI Pharmacies
This is a single-arm trial, so all pharmacies will serve as their own control.
We will enroll 10 community pharmacies.
These 10 pharmacies will continue to provide PEP/PrEP services as normal for several months (control).
Then, we will introduce the first phase of the intervention: the minimally viable product (MVP) version of the PEPPI software.
The second phase of the intervention will be the enhanced version of the PEPPI software.
The pharmacies will continue to provide PEP/PrEP services while using the PEPPI software in place of any paper or electronic processes that they were previously using.
The results will then be compared between the control and the intervention periods.
|
We will enroll 10 community pharmacies.
These 10 pharmacies will continue to provide PEP/PrEP services as normal for several months (control).
Then, we will introduce the first phase of the intervention: the minimally viable product (MVP) version of the PEPPI software.
The second phase of the intervention will use the enhanced version of the PEPPI software.
The pharmacies will continue to provide PEP/PrEP services while using the PEPPI software in place of any paper or electronic processes that they were previously using.
The results will then be compared between the control and the intervention periods.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Implementation - Service Characteristics Number of Pharmacists
時間枠：up to 12 months
|
Implementation outcomes will focus on how the service (pharmacist-prescribed PEP/PrEP services) is implemented.
Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure: -Number of pharmacists involved in providing birth control services
|
up to 12 months
|
|
Implementation - Service Characteristics Number of Pharmacy Staff
時間枠：up to 12 months
|
Implementation outcomes will focus on how the service (pharmacist-prescribed PEP/PrEP services) is implemented.
Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure: -Number of pharmacy staff (non-pharmacists) involved in providing PEP/PrEP services
|
up to 12 months
|
|
Implementation - Service Characteristics Cash Pay
時間枠：up to 12 months
|
Implementation outcomes will focus on how the service (pharmacist-prescribed PEP/PrEP services) is implemented.
Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure: -Total amount of money coming in (revenue) from the service via cash pay
|
up to 12 months
|
|
Implementation - Service Characteristics Insurance Billing
時間枠：up to 12 months
|
Implementation outcomes will focus on how the service (pharmacist-prescribed PEP/PrEP services) is implemented.
Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure: -Total amount of money coming in (revenue) from the service via insurance billing
|
up to 12 months
|
|
Implementation - Proctor Implementation Outcomes
時間枠：up to 12 months
|
Implementation outcomes will be measured using Proctor et al.'s (2011) implementation framework.
The domains in this framework include appropriateness, acceptability, adoption, feasibility, and fidelity.
Survey items will map to each of these domains.
Name of the measurement: Implementation - Proctor Implementation Outcomes Measurement tool: Implementation Outcomes Scale Unit of Measure: 5-point Likert-type scale (1= strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree).
This same scale is used for all implementation domains (appropriateness, acceptability, adoption, feasibility, and fidelity).
|
up to 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Access to Care
時間枠：up to 12 months
|
Access to Care outcomes will be assessed using an adapted version of the previously developed scale of Access to Contraceptive Care (Newlon 2021) that assesses patients' access in terms of approachability, acceptability, availability and accommodation, affordability, appropriateness, and privacy.
Unite of measure: 5-point Likert-type scale (1= strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree).
This same scale is used for all implementation domains (approachability, acceptability, availability and accommodation, affordability, appropriateness, and privacy).
|
up to 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年8月1日
研究の完了 (推定)
2028年9月1日
試験登録日
最初に提出
2026年6月27日
QC基準を満たした最初の提出物
2026年6月27日
最初の投稿 (実際)
2026年7月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月7日
QC基準を満たした最後の更新が送信されました
2026年7月2日
最終確認日
2026年7月1日
詳しくは
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