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临床试验/NCT07683117
NCT07683117招募中不适用

Impact of PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI)

EMPOWERX INC1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
195
试验地点
1
主要终点
Implementation - Service Characteristics Number of Pharmacists

研究概览

简要总结

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:

  1. Does the PEPPI software make it easier for pharmacists to provide PEP/PrEP services in their pharmacy?
  2. 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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:

研究组 & 干预措施

PEPPI Pharmacies

Other

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.

干预措施: PEPPI Pharmacies (Other)

结局指标

主要结局

Implementation - Service Characteristics Number of Pharmacists

时间窗: 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

Implementation - Service Characteristics Number of Pharmacy Staff

时间窗: 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

Implementation - Service Characteristics Cash Pay

时间窗: 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

Implementation - Service Characteristics Insurance Billing

时间窗: 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

Implementation - Proctor Implementation Outcomes

时间窗: 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).

次要结局

  • Access to Care(up to 12 months)

研究者

发起方
EMPOWERX INC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenny Newlon

Research Director

EMPOWERX INC

研究点 (1)

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