PrEP Optimization for HIV Prevention
(PrOTECT AL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve how clinics in Alabama use a data dashboard to enhance the delivery of PrEP, a medication that helps prevent HIV. By using this dashboard, clinics can better understand and address gaps in care, ensuring resources are directed where needed most. The trial focuses on healthcare providers and administrators involved in delivering or managing PrEP services at specific clinics. Participants should be English-speaking providers, clinic leaders, or data managers at one of the seven participating sites. As an unphased trial, this study offers participants the chance to contribute to innovative healthcare solutions that could improve PrEP delivery and patient outcomes.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the PrOTECT AL Implementation Strategy is safe?
Research has shown that PrEP (pre-exposure prophylaxis) is a safe and effective method for preventing HIV. Studies have found that most people tolerate PrEP well, with few reports of serious side effects. When side effects occur, they are usually mild, such as nausea or headache.
The PrOTECT AL Implementation Strategy aims to improve access to these safe PrEP services by using better data tools. This strategy does not involve new drugs or treatments, so it poses no risk of new side effects. The goal is to ensure more people can access PrEP, which is already proven safe for preventing HIV.12345Why are researchers excited about this trial?
Researchers are excited about the PrOTECT AL Implementation Strategy because it offers a new way to enhance access and delivery of PrEP (pre-exposure prophylaxis) for HIV prevention. Unlike current options, which often focus solely on individual prescriptions, this strategy provides a comprehensive data dashboard that helps clinics track and improve their PrEP services. It includes features like a PrEP coverage map and equity scores, helping identify areas with unmet needs and promoting fair access across communities. This approach aims to streamline PrEP service delivery and optimize its impact in preventing HIV.
What evidence suggests that the PrOTECT AL Implementation Strategy is effective for HIV prevention?
Research has shown that the PrOTECT AL Implementation Strategy, which participants in this trial will experience, aims to improve HIV prevention by using a data dashboard to enhance PrEP (pre-exposure prophylaxis) care. This dashboard helps clinics track how many patients are referred to, connected with, or given PrEP, and it highlights where PrEP services are most needed. By focusing on real-time data, clinics can better address gaps in care and ensure more people have access to PrEP. Early findings suggest that this strategy can help reduce health disparities related to HIV by ensuring at-risk groups receive the care they need. Although direct evidence of its effectiveness is not yet available, this approach aligns with proven methods for improving healthcare access and outcomes.13567
Who Is on the Research Team?
Michael Mugavero, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) who work as healthcare providers, clinical administrators, or data managers at one of seven specific clinics in Alabama. Participants must speak English.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implementation
Deployment of the PrOTECT AL dashboard and practice transformation implementation strategies across clinical sites
Evaluation
Evaluate implementation outcomes and effectiveness of the PrOTECT AL dashboard
Follow-up
Participants are monitored for changes in PrEP prescriptions and dashboard usage
What Are the Treatments Tested in This Trial?
Interventions
- PrOTECT AL Implementation Strategy
Trial Overview
The study is testing a new strategy that uses a real-time data dashboard to help clinics track and improve how they provide HIV prevention medication (PrEP). The goal is to find care gaps and make PrEP services better.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The PrOTECT AL dashboard consisted of a public-facing homepage with information on the purpose of the project, resources for finding PrEP services across the state, information on project partners, and reading materials on HIV and prevention efforts across AL. From the website, partners can access the data dashboard via a clinic-specific login where they view both aggregate data and their clinic-level data. Data elements include: number of patients referred for, linked to, prescribed, or discontinued from PrEP within the reporting period (3-month timeframe); primary PrEP indications recorded; and AL counties served. These elements can be filtered down by race, age, and gender. Additional proposed modifications, will include an PrEP coverage map, showing where the greatest unmet needs are for PrEP service delivery in the state as well as a PrEP equity scores, clinic performance indicator that will be populate every 3-months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
Utilizing Implementation Mapping to Ensure the Success of ...
For PrOTECT AL, we are conducting IM by engaging each of our community partners individually and collectively, using qualitative and quantitative methods to ...
Using Implementation Mapping to Ensure the Success of PrEP ...
This report demonstrates our use of Implementation Mapping (IM) to engage participating county health departments, AIDS services organizations, ...
A Type 3 Hybrid Effectiveness-Implementation Trial | AIDS and ...
This study sought to compare implementation and effectiveness outcomes for two delivery strategies of a digital HIV prevention intervention: ...
Using Implementation Mapping to Ensure the Success of ...
The PrO-TECT AL data dashboard was felt to be the key implementation strategy necessary to critically visualize and assess real-time data that would promote ...
Categorising implementation determinants and strategies ...
We plan to conduct three systematic reviews to identify and categorise determinants and strategies associated with three HIV focus areas.
National HIV/AIDS Strategy Federal Implementation Plan
Strategy 4.3.1 Promote the collection, electronic sharing, and use of HIV risk, prevention, and care and treatment data using interoperable data standards ...
HIV PREVENTION 2025 Road Map
The commitments are anchored in the 2025 Global AIDS Strategy targets, which include the: 95–95–95 targets for access to HIV services; the 10–10–10 targets for ...
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