HAPPI Software for Birth Control Access

(HAPPI Trial)

Overseen By Sally Rafie, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: EMPOWERX INC

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the HAPPI software can help pharmacists provide birth control more easily and improve patient access. The study will determine if using this software in pharmacies simplifies birth control management for both pharmacists and patients. Patients receiving birth control from a participating pharmacy or pharmacists providing it may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative solutions that could enhance pharmacy services and patient access to birth control.

Do I have to stop taking my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. It focuses on using the HAPPI software for birth control services, so it's unlikely that your other medications will be affected.

What prior data suggests that the HAPPI software is safe for improving birth control access?

Research has shown that the HAPPI software helps pharmacists offer birth control services more easily. As a software tool, not a drug or medical device, it has no reported safety issues or side effects. The aim is to simplify birth control services for both pharmacists and patients. The trial will evaluate the software's effectiveness in real-life pharmacy settings, not conduct safety testing on people. Participants can therefore expect very low risk when using the software in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HAPPI software because it aims to streamline the process of accessing birth control at pharmacies. Unlike traditional methods that rely on paper or separate electronic systems, HAPPI integrates the process into a single, unified software platform. This could reduce errors, speed up service, and improve the overall experience for both pharmacy staff and customers. By making birth control access more efficient and reliable, HAPPI could enhance public health outcomes.

What evidence suggests that the HAPPI software is effective for improving birth control access?

Research has shown that the HAPPI software is designed to help pharmacists provide birth control services more effectively and make these services more accessible to patients. This trial will evaluate the impact of HAPPI software in community pharmacies. Although limited data exists on HAPPI's effectiveness, similar tools have been tested. For example, the My Birth Control tool did not significantly change the duration of birth control use, with about 57% of users continuing. HAPPI aims to simplify the process, potentially making it easier for both pharmacists and patients to manage birth control services. Early indications suggest it could improve access and efficiency, but further research is needed to confirm its impact. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pharmacists and patients involved in birth control services. Pharmacists will use the HAPPI software to provide these services, while patients will access birth control through pharmacists using this technology. Specific eligibility criteria are not provided.

Inclusion Criteria

I am over 18, work in a pharmacy offering birth control, and use HAPPI software.

I am 18 or older and use HAPPI software for birth control services at a pharmacy.

Exclusion Criteria

I am not a pharmacist.

PATIENT Participants: None

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Pharmacies provide birth control services as normal without the HAPPI software

Several months

Intervention Period

Pharmacies provide birth control services using the HAPPI software

Up to 5 months

Follow-up

Participants are monitored for implementation outcomes and access to care

Up to 5 months

What Are the Treatments Tested in This Trial?

Interventions

• HAPPI software

Trial Overview

The study is testing whether the HAPPI software can make it easier for pharmacists to offer birth control services and for patients to access them. It compares scenarios with and without the software's use by evaluating implementation by pharmacists and accessibility for patients.

How Is the Trial Designed?

Group I: HAPPI Pharmacies Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

EMPOWERX INC

Lead Sponsor

Trials

1

Recruited

150+

Purdue University

Collaborator

Trials

239

Recruited

72,200+

Published Research Related to This Trial

The My Birth Control decision support tool did not significantly improve contraceptive continuation rates after 7 months, with continuation rates of 56.6% for the intervention group and 59.6% for the control group.

However, the tool enhanced the quality of the contraceptive counseling experience, leading to higher scores in interpersonal quality, informed decision-making, and contraceptive knowledge among users compared to those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. Dehlendorf, C., Fitzpatrick, J., Fox, E., et al.[2020]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06823037

Hormonal Contraception Access Through Pharmacist ...

Does the HAPPI software make it easier for patients to access birth control? Researchers will compare pharmacists' implementation and patients' access when ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/10385525

Hormonal contraceptive Access via Pharmacist-Prescribing ...

Outcomes; Clinical Studies; News and More; History; Similar Projects. Hormonal contraceptive Access via Pharmacist-Prescribing Implementation package (HAPPI).

3.

trial.medpath.com

trial.medpath.com/clinical-trial/0c15183cb64aa6ff/nct06823037-hormonal-contraception-pharmacist-prescribing

Hormonal Contraception Access Through Pharmacist ...

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 ...

4.

withpower.com

withpower.com/trial/happi-software-for-birth-control-access-18152

HAPPI Software for Birth Control Access

The My Birth Control decision support tool did not significantly improve contraceptive continuation rates after 7 months, with continuation rates of 56.6% for ...

5.

kff.org

kff.org/womens-health-policy/contraceptive-experiences-coverage-and-preferences-findings-from-the-2024-kff-womens-health-survey/

Contraceptive Experiences, Coverage, and Preferences

Among contraceptive users, one in five (21%) women with low incomes and those who have Medicaid coverage (20%) obtain their contraceptive care ...

6.

trialx.com

trialx.com/clinical-trials/listings/312955/hormonal-contraception-access-through-pharmacist-prescribing-implementation/

Hormonal Contraception Access Through Pharmacist ...

Overview. The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services.

7.

clinconnect.io

clinconnect.io/trials/NCT06823037

Hormonal Contraception Access Through Pharmacist

This clinical trial is investigating a new software called HAPPI that aims to help pharmacists provide birth control services more effectively. The main ...

8.

sbir.gov

sbir.gov/awards/213382

Award | SBIR

For the evaluative phase, we will bring the HAPPI software into a single pharmacy to test how the product works in a real-world environment. For the ...