Clinical trial NCT06823037: Hormonal Contraception Access Through Pharmacist Prescribing Implementation
Official title: HAPPI (Hormonal Contraception Access Through Pharmacist Prescribing Implementation): Phase 2 (Aim 1)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: EMPOWERX INC
Sponsor class: OTHER
Collaborators: name: Purdue University
First posted: 2025-02-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Implementation - Service Characteristics Number of Pharmacists
timeFrame: up to 5 months
measure: Implementation - Service Characteristics Number of Pharmacy Staff
timeFrame: up to 5 months
measure: Implementation - Service Characteristics Cash Pay
timeFrame: up to 5 months
measure: Implementation - Service Characteristics Insurance Billing
timeFrame: up to 5 months
measure: Implementation - Proctor Implementation Outcomes
timeFrame: up to 5 months
Secondary outcomes:
measure: Access to Care
timeFrame: up to 5 months
Other outcomes:
Locations:
city: Del Mar
country: United States
facility: EmpoweRx, Inc
state: California
Study officials:
References:
citation: 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.
citation: 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.