HIV PreventionPEPPINCT07683117
PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI)
A study testing PEPPI Pharmacies in people with HIV Prevention and HIV Pre-exposure Prophylaxis, run by EMPOWERX INC at 1 site in United States.
Trial 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. Does the PEPPI software make it easier for pharmacists to provide PEP/PrEP services in their pharmacy? 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, HIV Pre-exposure Prophylaxis, Access and Linkage to Healthcare
- What is being tested?
- PEPPI Pharmacies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- None
- PATIENT Participants
- NONE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sally Rafie, PharmD contact
United States1 site, 1 recruiting
- Recruiting
EmpoweRx, Inc
Del Mar, California, 92014
Sally Rafie, PharmD, 8584120984, sally@birthcontrolpharmacist.com
About this study
Official title: 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?
Read more
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.
- Conditions
- HIV Prevention, HIV Pre-exposure Prophylaxis, Access and Linkage to Healthcare, Technology Use
- Being tested
- PEPPI Pharmacies
- Keywords
- community pharmacy, access to care, pharmacist services, HIV prevention, PEP/PrEP, scope of practice, health technology, pharmacist prescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPPI PharmaciesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PEPPI Pharmacies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: up to 12 months
Secondary outcomes (1)
Access to Care
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).
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMPOWERX INC
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jenny Newlon, EMPOWERX INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683117
- Sponsor's protocol ID
- R44MH142152
- Other IDs
- R44MH142152
- Acronym
- PEPPI
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI)
- ClinicalTrials.gov ID
- NCT07683117
- Acronym / sponsor ID
- PEPPI / R44MH142152
- Conditions
- HIV Prevention, HIV Pre-exposure Prophylaxis, Access and Linkage to Healthcare, Technology Use
- Keywords
- community pharmacy, access to care, pharmacist services, HIV prevention, PEP/PrEP, scope of practice, health technology, pharmacist prescribing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- EMPOWERX INCUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEPPI Pharmacies | Other | Other: PEPPI PharmaciesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 18 years of age or older
- Seek PEP or PrEP services at a participating pharmacy
Key exclusion criteria (3 listed)
- None
- PATIENT Participants
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEPPI PharmaciesWe 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. | Other | PEPPI Pharmacies |
Primary outcome
Implementation - Service Characteristics Number of Pharmacists
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
1 secondary outcome
Access to Care
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sally Rafie, PharmD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEPPI Pharmacies in people with HIV Prevention and HIV Pre-exposure Prophylaxis, run by EMPOWERX INC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny L Newlon, PharmD, PhD (8584120984, jenny@birthcontrolpharmacist.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation - Service Characteristics Number of Pharmacists (time frame: up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.