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NCT Number: NCT06823037

Hormonal Contraception Access Through Pharmacist Prescribing Implementation

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.

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Key information

Conditions

Contraception Access and Linkage to Healthcare Pharmaceutical Services Technology Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EmpoweRx, Inc

Del Mar, California, 92014, United States

Location status: Recruiting

Location contact

Sally Rafie, PharmD

CONTACT

[email protected]

8584120984

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HAPPI software

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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).

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny L Newlon, PharmD, PhD

CONTACT

[email protected]

8584120984

Sally Rafie, PharmD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

EMPOWERX INC

Other

Collaborators

  • Purdue University

Registry information

Official study title

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

Acronym: HAPPI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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