PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI)

NCT07683117 | Recruiting

• 1 other identifier: R44MH142152
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Prevention; HIV Pre-exposure Prophylaxis; Technology Use; Access and Linkage to Healthcare

Keywords

community pharmacy; access to care; pharmacist services; HIV prevention; PEP/PrEP; scope of practice; health technology; pharmacist prescribing

Outcome Measures

Primary Outcomes (5)

• Implementation - Service Characteristics Number of Pharmacists

  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

  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

  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

  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

  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

Secondary Outcomes (1)

• Access to Care

  up to 12 months

Study Arms (1)

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.

Other: PEPPI Pharmacies

Interventions

PEPPI Pharmacies OTHER

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.

PEPPI Pharmacies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None
• PATIENT Participants
• 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
• NONE

Sponsors & Collaborators

• EMPOWERX INC: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

EmpoweRx, Inc

Del Mar, California, 92014, United States

RECRUITING

Central Study Contacts

Jenny L Newlon, PharmD, PhD

CONTACT

8584120984; jenny@birthcontrolpharmacist.com

Sally Rafie, PharmD

CONTACT

Sally@birthcontrolpharmacist.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

US (1)