56 Participants NeededMy employer runs this trial

PrEP Optimization for HIV Prevention

(PrOTECT AL Trial)

BJ
MP
Overseen ByMariel Parman, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

MM

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

I am 18 years old or older.
Currently practicing providers (clinician, nurse, or medical assistant), clinical administrator, or data manager
English speaking

Exclusion Criteria

Not one of the seven participating sites

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Deployment of the PrOTECT AL dashboard and practice transformation implementation strategies across clinical sites

36 months
Quarterly assessments

Evaluation

Evaluate implementation outcomes and effectiveness of the PrOTECT AL dashboard

36 months
Quarterly and 6-month interval assessments

Follow-up

Participants are monitored for changes in PrEP prescriptions and dashboard usage

36 months

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

Group I: PrOTECT AL Implementation StrategyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35703768/

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 ...