What side effects are associated with this type of intervention?

Common treatments for pre-exposure prophylaxis (PrEP) for HIV prevention, such as the use of medications like Truvada (emtricitabine/tenofovir) and Descovy (emtricitabine/tenofovir alafenamide), can have side effects. These may include gastrointestinal issues like nausea and diarrhea, headaches, and fatigue. Some patients may experience more serious side effects such as kidney problems or bone density loss, although these are less common. Regular monitoring by healthcare providers is essential to manage and mitigate these potential side effects.

What prior FDA approvals exist?

There are no FDA approvals specifically for Electronic Health Records (EHRs) as they are a tool rather than a treatment. However, strategies to improve knowledge and uptake of medical interventions, such as the educational/awareness strategy for PrEP in HIV prevention, are often supported by various health initiatives and programs. These strategies may include the use of computerized alerts, pharmacist-mediated academic detailing, and patient education materials to enhance adherence to treatment guidelines and improve health outcomes.

What other types of research exist?

Promising novel alternatives to educational/awareness strategies for improving PrEP knowledge and uptake among EHR patients in 2024 include: 1) Telemedicine consultations to provide personalized PrEP counseling and follow-up; 2) AI-driven personalized recommendations within EHR systems to identify and notify high-risk patients; 3) Mobile health applications that offer PrEP education, reminders, and adherence tracking; 4) Integrated care models that combine PrEP services with routine primary care visits to ensure comprehensive patient management.

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The EMC2 PrEP Strategy for Electronic Health Records

N/A

Recruiting

Led By Allison Pack, PhD, MPH

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

not currently using PrEP

female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is trying to find a way to help women in primary care learn more about and use a method called pre-exposure prophylaxis (PrEP) to prevent HIV infection.

Who is the study for?

This trial is for cisgender women who are HIV negative, not currently using PrEP, and engaged in primary care. They must have been tested at least twice in the past year or diagnosed with certain STIs like chlamydia, gonorrhea, or syphilis within the last six months.Check my eligibility

What is being tested?

The study tests an educational tool called EMC2 PrEP to see if it helps increase knowledge and use of HIV prevention methods. It also looks at organizing a dedicated visit for discussing PrEP as part of this strategy.See study design

What are the potential side effects?

Since this trial focuses on education and scheduling strategies rather than medication, there are no direct side effects from interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not currently using PrEP.

Select...

I am female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PrEP Uptake

Secondary outcome measures

PrEP Knowledge

Trial Design

2Treatment groups

Active Control

Group I: The EMC2 PrEP StrategyActive Control2 Interventions

The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.

Group II: Usual CareActive Control1 Intervention

Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Electronic Health Records (EHRs) can significantly enhance patient education and engagement by systematically integrating educational materials and reminders into the patient's health management plan. For instance, in the context of increasing PrEP knowledge and uptake for HIV prevention, EHRs can be programmed to identify eligible patients and automatically provide them with tailored educational content and reminders during their visits. This ensures that patients receive consistent and accurate information, which can improve their understanding and adherence to preventive measures. By leveraging EHRs in this way, healthcare providers can more effectively promote preventive health strategies, ultimately leading to better health outcomes for patients.

What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project.Use of Behavioral Economics to Improve Medication Adherence in Severe Mental Illness.Email for the provision of information on disease prevention and health promotion.

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,601 Previous Clinical Trials

915,459 Total Patients Enrolled

1 Trials studying Electronic Health Records

840 Patients Enrolled for Electronic Health Records

Merck Sharp & Dohme LLCIndustry Sponsor

3,907 Previous Clinical Trials

5,065,836 Total Patients Enrolled

Allison Pack, PhD, MPHPrincipal InvestigatorNorthwestern University

~60 spots leftby Sep 2024

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