Hormonal Contraception Access Through Pharmacist Prescribing Implementation

NCT06823037 | Recruiting

• 1 other identifier: R44DP006691
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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).

  up to 5 months

Secondary Outcomes (1)

• Access to Care

  up to 5 months

Study Arms (1)

HAPPI Pharmacies

OTHER

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

Interventions

HAPPI software OTHER

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.

HAPPI Pharmacies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Provide birth control services in a participating pharmacy
• Use the HAPPI software to provide birth control services

You may not qualify if:

• None
• PATIENT Participants
• 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
• NONE

Sponsors & Collaborators

• EMPOWERX INC: lead
• Purdue University: collaborator

Study Sites (1)

EmpoweRx, Inc

Del Mar, California, 92014, United States

RECRUITING

Related Publications (2)

• Newlon JL, Campi JA, Rafie S, Meredith AH. Determining user implementation needs for pharmacist-prescribed contraception using concept mapping: A participatory, multiple stakeholder approach. Explor Res Clin Soc Pharm. 2024 Oct 11;16:100525. doi: 10.1016/j.rcsop.2024.100525. eCollection 2024 Dec.

  PMID: 39512515 BACKGROUND

• Campi JA, Rafie S, Newlon JL, Meredith AH. Implementation of pharmacist-prescribed contraceptive services: A case series of early adopters. JAPhA Pract Innov. 2024 Jul;1(3):100011. doi: 10.1016/j.japhpi.2024.100011. Epub 2024 Apr 20.

  PMID: 39420991 BACKGROUND

Central Study Contacts

Jenny L Newlon, PharmD, PhD

CONTACT

8584120984; jenny@birthcontrolpharmacist.com

Sally Rafie, PharmD

CONTACT

Sally@birthcontrolpharmacist.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 12, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)