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Hormonal Contraception Access Through Pharmacist Prescribing Implementation

HAPPI (Hormonal Contraception Access Through Pharmacist Prescribing Implementation): Phase 2 (Aim 1)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06823037
Acronym
HAPPI
Enrollment
150
Registered
2025-02-12
Start date
2025-10-09
Completion date
2026-08-31
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Access and Linkage to Healthcare, Contraception, Pharmaceutical Services, Technology Use

Keywords

community pharmacy, access to care, pharmacist services, birth control, health technology, scope of practice

Brief summary

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: 1. Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy? 2. Does the HAPPI software make it easier for patients to access birth control? 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.

Interventions

OTHERHAPPI 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.

Sponsors

Purdue University
CollaboratorOTHER
EMPOWERX INC
Lead SponsorOTHER

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
No

Inclusion criteria

PHARMACIST Participants Inclusion Criteria: * 18 years of age or older * Provide birth control services in a participating pharmacy * Use the HAPPI software to provide birth control services

Exclusion criteria

* None PATIENT Participants Inclusion Criteria: * 18 years of age or older * Seek birth control services at a participating pharmacy * Use the HAPPI software to receive birth control services at a participating pharmacy

Design outcomes

Primary

MeasureTime frameDescription
Implementation - Service Characteristics Number of Pharmacistsup to 5 monthsImplementation 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
Implementation - Service Characteristics Number of Pharmacy Staffup to 5 monthsImplementation 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
Implementation - Service Characteristics Cash Payup to 5 monthsImplementation 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
Implementation - Service Characteristics Insurance Billingup to 5 monthsImplementation 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
Implementation - Proctor Implementation Outcomesup to 5 monthsImplementation 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

MeasureTime frameDescription
Access to Careup to 5 monthsAccess 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).

Countries

United States

Contacts

Primary ContactJenny L Newlon, PharmD, PhD
jenny@birthcontrolpharmacist.com8584120984
Backup ContactSally Rafie, PharmD
Sally@birthcontrolpharmacist.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026