PEP/PrEP via Pharmacist-Prescribing Implementation (PEPPI) Phase II

Informed Consent

Sally Rafie, PharmD and Jenny Newlon, PharmD, PhD, Principal Investigators
EmpoweRx, Inc.

Key Information

The following is a concise and focused presentation of key information to assist you in understanding why you might or might not want to participate in this research.

You are being asked to be in a research study because you can provide useful information about what makes it easy or difficult to prescribe PEP/PrEP for patients.
Your participation is voluntary. You may refuse to participate or withdraw at any time without penalty or loss of benefits to which you are otherwise entitled.
The purpose of this study is to learn about how software can affect pharmacist-prescribed PEP/PrEP services.
Your participation in this study is expected to last no more than 20 minutes per survey, totalling 120 minutes (20 minutes x 6 surveys) spanning approximately 18 months.
The main study procedures include using the novel PEPPI software in place of all current paper and digital processes to provide PEP/PrEP services and completing six online surveys.
The risks of this study include breach of confidentiality is always a risk with data, but we will take precautions to minimize this risk. The risks are no greater than the participant would encounter in daily life or during the performance of routine physical or psychological exams or tests.
There is no direct benefit to you from taking part in this study. However, information we learn from this study may help people in the future.
This overview does not include all the information you need to know before deciding whether to take part in this study. Additional detail is given in the rest of this consent form found on the pages that follow. Be sure to review the rest of this consent form before deciding to participate.


Who Is the Study Team and How Is This Study Funded?
This research study is being conducted by Sally Rafie, PharmD and Jenny Newlon, PharmD, PhD at EmpoweRx, Inc. The National Institutes of Health (NIH) has provided funding for this study.


How Many People Will Take Part in This Study?
About 10 pharmacies are expected to participate in this study.


What Is Involved in This Research Study?
All pharmacies will be asked to participate in a clinical trial spanning 18 months. Pharmacy site contacts will be asked to complete an online survey at six timepoints during the control phase of the clinical trial. As the pharmacy site contact, your direct participation will last up to 120 minutes total (20 minutes x 6 surveys).

Will Participating in This Study Benefit Me?
Participating in this study may not benefit you directly, but it will help us learn how to make it easier for pharmacists to prescribe PEP/PrEP for patients using a novel software.


What Are the Risks Associated With This Research?
You may find answering some of the questions upsetting, but we expect that this would not be different from the kinds of things you discuss with family or friends. You may skip any questions you don’t want to answer, and you may end the survey at any time. Your participation in this study is completely voluntary, and your alternative is to not take part in this study.


What Are the Costs of Taking Part in This Study?
There are no costs to you for taking part in this study. All the study costs, including any study tests, supplies, and procedures related directly to this study, will be paid for by the study.
Will There Be Compensation for Participating?

If your pharmacy participates in this study, you will receive $500 for completing the control phase (6 months, no software), $500 for completing the Intervention Phase I, and $2000 for completing Intervention Phase II, for a maximum total of $3,000 per pharmacy site. Completion of the control phase requires the site contact to share administrative data via 6 online surveys for the control phase. Completion of the Intervention Phases requires the site contact to implement the software for the duration of the phase and see at least 2 patients per 6-month phase for pharmacist-prescribed PEP/PrEP services. Partial completion (i.e. seeing only 1 patient for PEP/PrEP services per phase) will result in receiving half the incentive amount for that phase. Seeing no patients for PEP/PrEP services in a phase will result in no incentive being granted for that phase.

You will receive the incentive as an e-gift card or e-prepaid visa via email within two weeks of completing each phase of the study. If you have any questions related to compensation, please contact Jenny Newlon at jenny@birthcontrolpharmacist.com, 858-412-0984.


What About Confidentiality?

To the extent allowed by law, every effort will be made to keep your personal information confidential. However, information from this study may be looked at by the research team, the institution, California, the sponsor/funding agency supporting this study (National Institutes of Health), and those responsible for overseeing the conduct of research. This may include representatives from the federal Office for Human Research Protections (OHRP) or other regulatory agencies, the Institutional Review Board (IRB), and the Biomedical Research Alliance of New York. While these parties are aware of the need to keep your information confidential, total confidentiality cannot be guaranteed. The results of this study may be presented at meetings or in publications; however, you will not be identified in these presentations and/or publications.

If you take part in this study, you will be assigned a unique subject code to help protect your privacy. Your study records and study samples will be labeled with this code that does not directly identify you. The study site staff will securely store the linking code between your name and study information.

Your email address will be collected for study related communication, such as survey and incentive distribution. Your email address will not be shared with anyone outside of study team members responsible for study related communications.No one at the National Institutes of Health (NIH) will be able to see your survey or even know whether you participated in this study. Study findings will be presented only in summary form and your email address will not be used in any report. While the investigator(s) will keep your information confidential, there are some risks of data breaches when sending information over the internet that are beyond the control of the investigator(s).

Question Title

* 1. This research is covered by a Certificate of Confidentiality from the NIH and National Institute of Mental Health Data Archive (NDA). The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. For additional information about CoCs see https://grants.nih.gov/policy-and-compliance/policy-topics/human-subjects/coc/nih-funded-research.


A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

What About Identifiable Private Information?

Identifiers might be removed from your identifiable private information. After such removal, the information could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent.




Whom Do You Call if You Have Questions or Problems?

If you have any questions about this study, please contact Jenny Newlon at jenny@birthcontrolpharmacist.com, 858-412-0984.

If you have any questions or complaints, you may contact a person not on the research team at the Biomedical Research Alliance of New York Institutional Review Board at (516) 318-6877 or at www.branyirb.com/concerns-about-research.


By completing this survey, you are consenting to participate in this study.


*Please print or save a copy of this form for your records.*

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