Implementation Strategy for HIV Prevention in Drug Addiction
(P2PH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to identify the best methods for outpatient clinics to provide sterile injection equipment and HIV prevention medication (PrEP) to people who inject drugs. The goal is to reduce the risk of serious infections, including HIV, among this group. Participants will engage in a study testing various strategies, known as an implementation strategy bundle, to introduce these tools and medications into clinics that currently lack them. This trial suits individuals who have injected drugs in the past year and seek ways to protect themselves from infections. As an unphased trial, it offers participants the chance to contribute to innovative strategies that could significantly enhance public health.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that this implementation strategy is safe?
Research shows that using a set of strategies, including clean injection equipment and HIV prevention tools like PrEP (pre-exposure prophylaxis), is safe and well-received. Past efforts to use similar strategies in healthcare settings have proven practical and welcomed by patients. This indicates that people generally manage the treatments well, with no major safety issues reported.
The aim is to help prevent HIV and serious infections among people who inject drugs. The strategy focuses on making these important resources more available and easier to access in clinics. While the trial is currently testing how well this strategy can be implemented, existing evidence supports the safety of individual components, like PrEP. PrEP, for example, is an FDA-approved medication for preventing HIV in people at risk, providing additional assurance about its safety.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new implementation strategy for HIV prevention specifically tailored for individuals with drug addiction. Unlike standard prevention methods that often rely on medication adherence and regular check-ups, this strategy focuses on integrating HIV prevention into the daily routines and environments of those struggling with addiction. By addressing the unique challenges and barriers faced by this group, the strategy aims to enhance the effectiveness and accessibility of HIV prevention efforts. This approach has the potential to significantly reduce HIV transmission rates in a population that is often underserved by traditional methods.
What evidence suggests that this implementation strategy bundle is effective for HIV prevention in drug addiction?
This trial will compare an implementation strategy bundle for HIV prevention with a waitlist control. Research has shown that providing clean needles and HIV prevention medication (PrEP) to people who inject drugs can significantly reduce their risk of contracting HIV. Studies have found that when clinics adopt specific methods to deliver these services, more individuals undergo HIV testing. Regular testing is crucial for preventing HIV and enabling early treatment. Additionally, these methods have successfully increased the use of essential health services in clinics. By making these resources more accessible, clinics can bridge the gap between known HIV prevention strategies and common practice.678910
Who Is on the Research Team?
Raagini Jawa, MD, MPH
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for people who inject drugs and are at risk of HIV and serious injection-related infections. It aims to help outpatient clinics provide sterile injection equipment and daily oral HIV pre-exposure prophylaxis (PrEP). The eligibility criteria details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Waitlist Control
Participants in the waitlist control arm wait for 6 months with no intervention
Intervention
Participants in the intervention arm receive the implementation strategy bundle immediately
Follow-up
Participants are monitored for site-level adoption and maintenance, and clinical outcomes such as SIRI-related hospitalizations and negative HIV test results
What Are the Treatments Tested in This Trial?
Interventions
- Implementation strategy bundle
Trial Overview
The Prescribe to Prevent HIV (P2PH) trial is testing a set of strategies designed to encourage outpatient addiction clinics to offer sterile injection tools and PrEP, in order to prevent the spread of HIV among those who inject drugs.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Waits for 6 months with no intervention, then gets the intervention of the implementation strategy bundle.
Immediately gets the intervention of the implementation strategy bundle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Developing a Practice-Driven Taxonomy of Implementation ...
We defined an implementation strategy as any method or technique described by participants as being used to enhance enactment of HIV prevention ...
2.
hivimpsci.northwestern.edu
hivimpsci.northwestern.edu/longitudinal-implementation-strategy-tracking-system/Longitudinal Implementation Strategy Tracking System
It includes three components: 1) a strategy assessment, 2) a data capture platform, and 3) a user guide. LISTS enables users to bundle strategies together and ...
Implementation of a bundle to improve HIV testing during ...
To measure effectiveness of the PWID bundle on increasing HIV testing, we analyzed the number of HIV tests done per month in hospitalizations ...
Working with HIV clinics to adopt addiction treatment using ...
The study was conducted at four HIV clinics in the northeast United States, using a hybrid type 3 effectiveness-implementation stepped wedge ...
5.
implementationscience.biomedcentral.com
implementationscience.biomedcentral.com/articles/10.1186/s13012-024-01379-3a Delphi study for HIV services | Implementation Science
Briefly, we structured our initial tool along six domains: overall effectiveness, study design quality, implementation outcomes, equity impact, ...
Implementation of a bundle to improve HIV testing during ...
Engagement of key stakeholders to increase HIV testing in an inpatient setting led to the implementation of a PWID bundle, which was feasible and acceptable.
Implementation of a bundle to improve HIV testing during ...
A PWID care bundle was developed and implemented, which included (1) HIV screening; (2) hepatitis A, B, and C testing and vaccination; (3) medications for ...
National HIV/AIDS Strategy Federal Implementation Plan
A data-driven strategy will help stakeholders focus efforts and efficiently and effectively use available resources. Integrating HIV testing, prevention, care, ...
9.
implementationsciencecomms.biomedcentral.com
implementationsciencecomms.biomedcentral.com/counter/pdf/10.1186/s43058-025-00746-5.pdffast tracking, provider re-training, and co-location
HIV testing decreases associated with the implementation strategy bundle were more pronounced among women seeking their first ANC visit. Differ-.
The Past, Present, and Future of PrEP implementation ...
Abstract. Purpose of review. Recent HIV outbreaks among people who use drugs (PWUD) necessitate additional HIV prevention tools.
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