Hormonal Contraception Access Through Pharmacist Prescribing Implementation (HAPPI)

December 2, 2025 updated by: Jenny Newlon, EMPOWERX INC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  • NONE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation - Service Characteristics Number of Pharmacists
Time Frame: up to 5 months

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
Time Frame: up to 5 months

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
Time Frame: up to 5 months

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
Time Frame: up to 5 months

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
Time Frame: up to 5 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).
up to 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access to Care
Time Frame: up to 5 months

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).
up to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMPOWERX INC

Collaborators

Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R44DP006691 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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