An interventional study of HAPPI software in Contraception, Pharmaceutical Services and Access and Linkage to Healthcare, sponsored by EMPOWERX INC. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by EMPOWERX INC · Not applicable, Interventional, and Health services research
The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are:
Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access.
Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.
EMPOWERX INC is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
PHARMACIST Participants
Inclusion Criteria:
Exclusion Criteria:
PATIENT Participants
Inclusion Criteria:
Exclusion Criteria:
This is a single-arm trial, so all pharmacies will serve as their own control. We will enroll 15 community pharmacies. These 15 pharmacies will continue to provide birth control services as normal for several months (control). Then, we will introduce the intervention: the HAPPI software. The pharmacies will continue to provide birth control services while using the HAPPI 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 period.
Other: HAPPI software
We will enroll 15 community pharmacies. These 15 pharmacies will continue to provide birth control services as normal for several months (control). Then, we will introduce the intervention: the HAPPI software. The pharmacies will continue to provide birth control services while using the HAPPI 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 period.
Implementation - Service Characteristics Number of Pharmacists
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive 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 5 months
Implementation - Service Characteristics Number of Pharmacy Staff
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive 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 birth control services
Time frame: up to 5 months
Implementation - Service Characteristics Cash Pay
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive 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 5 months
Implementation - Service Characteristics Insurance Billing
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive 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 5 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).
Time frame: up to 5 months
Access to Care
Access to Care outcomes will be assessed using a 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 5 months
Plan to share: Undecided — Our clinical trial uses proprietary information related to the software that is the basis for our intervention. We will need to find a way to ensure we protect all intellectual property and proprietary information before we develop a plan to share IPD.
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