Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44MH142152 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
PHARMACIST Participants
Inclusion Criteria:
Exclusion Criteria:
PATIENT Participants
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny L Newlon, PharmD, PhD | Contact | 8584120984 | jenny@birthcontrolpharmacist.com | |
| Sally Rafie, PharmD | Contact | Sally@birthcontrolpharmacist.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EmpoweRx, Inc | Recruiting | Del Mar | California | 92014 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| up to 12 months |
| up to 12 months |