Recruiting

HAPPI Software

Sponsor:

EMPOWERX INC

Code:

NCT06823037

Conditions

Contraception

Pharmaceutical Services

Access and Linkage to Healthcare

Technology Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HAPPI software

Study Details

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.

Conditions

Contraception

Pharmaceutical Services

Access and Linkage to Healthcare

Technology Use

Study ID

NCT06823037

Start date

Oct 9, 2025

Status verified date

Dec, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Implementation - Service Characteristics Number of Pharmacists [ Time Frame: up to 5 months ]
  • Implementation - Service Characteristics Number of Pharmacy Staff [ Time Frame: up to 5 months ]
  • Implementation - Service Characteristics Cash Pay [ Time Frame: up to 5 months ]
  • Implementation - Service Characteristics Insurance Billing [ Time Frame: up to 5 months ]
  • Implementation - Proctor Implementation Outcomes [ Time Frame: up to 5 months ]

Central Contacts and Locations

Central contacts

Jenny L Newlon, PharmD, PhD

8584120984jenny@birthcontrolpharmacist.com

Sally Rafie, PharmD

Sally@birthcontrolpharmacist.com

Locations

EmpoweRx, Inc

Recruiting

Del Mar, California, United States, 92014

Contacts

Sally Rafie, PharmD

8584120984mail@birthcontrolpharmacist.com

More Information

Sponsor

EMPOWERX INC

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by EMPOWERX INC on 2025-12-04.