150 Participants Needed

HAPPI Software for Birth Control Access

(HAPPI Trial)

JL
SR
Overseen BySally Rafie, PharmD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: EMPOWERX INC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

How does the HAPPI Software for Birth Control Access treatment differ from other birth control methods?

HAPPI Software for Birth Control Access is unique because it likely uses a digital platform to enhance communication and self-efficacy in using long-acting reversible contraception (LARC), unlike traditional methods that rely solely on in-person counseling. This approach can provide personalized support and information, making it easier for users to discuss and manage their birth control options.12345

What is the purpose of this trial?

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

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: HAPPI PharmaciesExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

EMPOWERX INC

Lead Sponsor

Trials
1
Recruited
150+

Purdue University

Collaborator

Trials
239
Recruited
72,200+

Findings from Research

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

References

Feasibility study of the use of a daily electronic mail reminder to improve oral contraceptive compliance. [2019]
The Performance of Fertility Awareness-based Method Apps Marketed to Avoid Pregnancy. [2022]
"It's Pretty Hard to Tell Your Mom and Dad That You're on a Method": Exploring How an App Could Promote Adolescents' Communication with Partners and Parent(s) to Increase Self-Efficacy in Long-Acting Reversible Contraception Use. [2018]
Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. [2020]
Mobile application for information on reversible contraception: a randomized controlled trial. [2015]
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