Hormonal Contraception Access Through Pharmacist Prescribing Implementation

NCT ID: NCT06823037

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-09

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception Pharmaceutical Services Access and Linkage to Healthcare Technology Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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HAPPI Pharmacies

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.

Group Type OTHER

HAPPI software

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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


* 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

Exclusion Criteria

* None

PATIENT Participants


* NONE
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue University

OTHER

Sponsor Role collaborator

EMPOWERX INC

OTHER

Sponsor Role lead

Responsible Party

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Jenny Newlon

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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EmpoweRx, Inc

Del Mar, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jenny L Newlon, PharmD, PhD

Role: CONTACT

8584120984

Sally Rafie, PharmD

Role: CONTACT

Facility Contacts

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Sally Rafie, PharmD

Role: primary

8584120984

References

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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.

Reference Type BACKGROUND
PMID: 39512515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39420991 (View on PubMed)

Other Identifiers

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R44DP006691

Identifier Type: NIH

Identifier Source: org_study_id

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