PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMPOWERX INC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
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
Trial design
Design model
Single group
Treatments tested in this trial
PEPPI Pharmacies
Other interventionWe 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.
Treatment groups
195 Participants
are divided into 1 treatment groupGroup A: PEPPI PharmaciesOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
up to 12 months2
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
Time frame
up to 12 months3
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
Time frame
up to 12 months4
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
Time frame
up to 12 monthsSecondary 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).
Time frame
up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
EMPOWERX INC
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov