Access and Linkage to Healthcare, HIV Pre-exposure Prophylaxis, HIV Prevention, Technology Use
Conditions
Keywords
community pharmacy, access to care, pharmacist services, HIV prevention, PEP/PrEP, scope of practice, health technology, pharmacist prescribing
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. 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.
Interventions
OTHERPEPPI Pharmacies
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.
Sponsors
EMPOWERX INC
National Institute of Mental Health (NIMH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
* None 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implementation - Service Characteristics Number of Pharmacists | 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 | 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 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access to Care | up to 12 months | 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). |
Countries
United States
Contacts
CONTACTJenny L Newlon, PharmD, PhD
CONTACTSally Rafie, PharmD
Outcome results
None listed