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Recruiting NCT06823037

Hormonal Contraception Access Through Pharmacist Prescribing Implementation

No phase Interventional Contraception Pharmaceutical Services Access and Linkage to Healthcare Technology Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HAPPI software.
Who it may be relevant to
Registry conditions: Contraception, Pharmaceutical Services, Access and Linkage to Healthcare, Technology Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Access to Care [Time frame: up to 5 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • EmpoweRx, Inc — Del Mar

Publications

  • 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
  • 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

Identifiers

NCT: NCT06823037 · R44DP006691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗