Implementation Strategy for HIV Prevention in Drug Addiction

(P2PH Trial)

Not yet recruiting at 3 trial locations

Overseen By Raagini Jawa, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Under 18, Non-English, Legal issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

Adult patients with history of active injection drug use in the past 1 year from the 4 COEs

Prescribing clinicians (e.g., physicians, advanced practice providers such as nurse practitioners and physician assistants), administrators, medical assistants, and nurses from the 4 COEs

Exclusion Criteria

Staff outside the specified roles (i.e., not prescribing clinicians, administrators, medical assistants, or nurses)

I will not be working or am on extended leave during the study.

History of injection drug use >1 year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants in the waitlist control arm wait for 6 months with no intervention

6 months

Intervention

Participants in the intervention arm receive the implementation strategy bundle immediately

6 months

Follow-up

Participants are monitored for site-level adoption and maintenance, and clinical outcomes such as SIRI-related hospitalizations and negative HIV test results

12 months

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?

Group I: Waitlist Control Arm Experimental Treatment 1 Intervention

Waits for 6 months with no intervention, then gets the intervention of the implementation strategy bundle.

Group II: Intervention Arm Experimental Treatment 1 Intervention

Immediately gets the intervention of the implementation strategy bundle.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841722/

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 ...

3. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/26334895231203410

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7511156/

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/s13012-024-01379-3

a 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, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10548809/

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.

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/26334895231203410

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 ...

8. files.hiv.gov files.hiv.gov/s3fs-public/2022-09/NHAS_Federal_Implementation_Plan.pdf

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.pdf

fast 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-.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8286349/

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.