Decision Support Tool for HIV Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new tool designed to help people start and maintain pre-exposure prophylaxis (PrEP), a medication that prevents HIV. Researchers aim to determine if this decision support tool can facilitate the initiation and continuation of PrEP for patients visiting emergency departments or urgent care centers. They seek English-speaking individuals who are medically stable, HIV-negative, and not currently taking PrEP or PEP (post-exposure prophylaxis). The trial will occur in Baltimore, MD, and Washington, DC.
As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to use this innovative tool.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications that affect the kidneys or have conditions that conflict with PrEP medications.
What prior data suggests that this decision support tool is safe for use in HIV prevention?
Research shows that decision support tools (DSTs) are usually safe and easy for people to use. These tools help individuals make informed choices about preventing HIV, especially through pre-exposure prophylaxis (PrEP), a method to stop HIV infection before it happens. Studies have found that DSTs can help people better understand their risk and learn more about PrEP without causing harm.
However, this study is in its early stages. The main goal is to assess the tool's safety and user-friendliness. While detailed safety information about this specific DST is not yet available, DSTs are generally designed to aid, not hinder, medical decisions, suggesting they are low-risk. Participation in the trial will help researchers confirm the tool's safety and effectiveness in real-life situations.12345Why are researchers excited about this trial?
Researchers are excited about the Decision Support Tool (DST) for HIV prevention because it aims to enhance the effectiveness of pre-exposure prophylaxis (PrEP) by integrating structured patient engagement. Unlike current PrEP protocols that rely heavily on patient initiative and healthcare provider recommendations, the DST provides a systematic approach to identify and address individual patient needs and resources. By incorporating this tool into patient interactions, the goal is to increase adherence to PrEP regimens and ultimately improve prevention outcomes. This approach could make HIV prevention more personalized and accessible, addressing barriers that traditional methods may not effectively overcome.
What evidence suggests that this decision support tool is effective for optimizing PrEP initiation and persistence?
Research shows that decision support tools (DST) can help people make better choices about using pre-exposure prophylaxis (PrEP) to prevent HIV. In this trial, participants in the ED-PrEP + DST arm will use the DST, which previous studies have shown helps identify 52% of patients at risk for HIV, with 38% deciding to start PrEP after counseling. This suggests that the tool can help people understand their risk of HIV and make informed decisions about starting PrEP. Another study found that the DST improved people's understanding of PrEP and increased their motivation to use it. These findings suggest that the DST can effectively support people in starting and continuing PrEP by providing clear information and guidance.12367
Are You a Good Fit for This Trial?
This trial is for individuals identified in emergency departments and urgent care settings as eligible for PrEP, a medication that helps prevent HIV. The study aims to help these patients start and continue taking PrEP by using a decision support tool tailored to their personal medical and social needs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: ED-PrEP (Pre-DST)
PrEP eligible patients receive a PrEP prescription facilitated by a PrEP Champion without the DST intervention
Phase 2: ED-PrEP + DST (Post-DST)
PrEP Champions integrate the DST into patient encounters, facilitating the use of the DST and provision of resources
Follow-up
Participants are monitored for PrEP persistence, adherence, and linkage to care
What Are the Treatments Tested in This Trial?
Interventions
- Decision Support Tool
Trial Overview
The trial is testing a personalized decision support tool designed to improve the initiation and persistence of PrEP treatment among patients. It will be conducted in two emergency departments and an urgent care center through a pilot stepped wedge implementation trial with 120 participants.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
In Phase 2 (Post-DST) PrEP Champions will integrate the DST into all patient encounters, facilitating the use of the DST as well as the provision of any identified resources.
In Phase 1 (Pre-DST) PrEP eligible patients who have agreed to PrEP will receive a PrEP prescription facilitated by a PrEP Champion; there will be no structured engagement intervention (i.e., the DST).
Find a Clinic Near You
Who Is Running the Clinical Trial?
George Washington University
Lead Sponsor
Johns Hopkins University
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Citations
Decision Support Tool to Improve Decision-Making for HIV ...
Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability.
Decision Support Tool to Improve Decision-Making for HIV Pre ...
Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability.
Incorporation of an Evidence-Based HIV Risk Assessment ...
The provider decision support tool identified 127 patients (52%) at risk for HIV infection. These patients were counseled about PrEP, and 93 (38%) accepted ...
A decision support tool has similar high PrEP uptake and ...
A decision support tool (DST) with information about PrEP could improve clients' risk perception, knowledge about PrEP, informed decision-making and motivation ...
Leveraging Electronic Health Record Data in a Risk ...
The study team will assess what information PCPs would like to have included in the clinical decision support tool. Recognizing that time constraints are a ...
Clinical Decision Support System to Increase HIV Screening
HIV Prevention: Clinical Decision Support System to Increase HIV Screening ... prevent new HIV transmission, improve health outcomes of people with HIV, and
7.
implementationsciencecomms.biomedcentral.com
implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-023-00394-7Provider perspectives on clinical decision support to improve ...
Clinical decision support (CDS) is a promising intervention for improving uptake of HIV testing and pre-exposure prophylaxis (PrEP).
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