Prescribe to Prevent HIV: A Hybrid Type 3 Trial to Help Outpatient Addiction Clinics Support Safer Drug Use and Prevent HIV and Other Serious Infections

Not Applicable

Not yet recruiting

• Conditions: People Who Use Opioids/People With Opioid Use Disorder (OUD)

• Registration Number: NCT07073924
• Lead Sponsor: University of Pittsburgh

Brief Summary

In the U.S., an estimated 3.6 million people who inject drugs (PWID) face a growing yet preventable health crisis, with rising cases of serious injection-related infections (SIRI), including HIV, due to limited access to two high-priority interventions: sterile injection equipment and daily oral HIV pre-exposure prophylaxis (PrEP). Outpatient clinics represent an opportune venue to implement these interventions. Yet most clinical providers in these settings do not currently provide them, contributing to a wide gap between evidence and routine practice. The Prescribe to Prevent HIV (P2PH) trial is a participatory study designed to co-develop and pilot test a set of implementation strategies to support outpatients clinics in offering sterile injection equipment and PrEP with the goal of reducing the risk of HIV and SIRI among PWID.

Detailed Description

In the U.S., the 3.6 million people who inject drugs (PWID) face a syndemic of overdose and severe injection related infections (SIRI). Current efforts addressing this crisis fall short as evidence-informed interventions (EIIs) to prevent or reduce SIRI from injection opioid use are not widely implemented and typically limited to syringe service programs. SIRI, which includes bacterial infections (e.g., cellulitis, osteomyelitis, endocarditis), hepatitis C virus, and HIV, significantly increase morbidity, mortality, and costs. Notably, HIV can be prevented through access to two EIIs: sterile injection equipment and pre-exposure prophylaxis (PrEP). However, PWID in many jurisdictions lack access to these interventions due to shortages of syringe servie programs and clinicians willing to prescribe them. As a result, PWID nationwide have seen rising HIV incidence, threatening the goal of ending the HIV epidemic by 2030. For example, in Pennsylvania, where 90% of PWID lack access to SSPs, acute HIV infections rose by 150% between 2016 and 2019, and SIRI-related hospitalizations increased by 250% since 2010. This wide evidence-to-implementation gap underscores the urgent need for participatory implementation research to integrate these two high-priority EIIs into routine medical practice.

Outpatient clinics represent a missed opportunity to implement these two EIIs. Outpatient clinics, including primary care and Federally Qualified Health Centers, are more accessible and face less restrictions than SSPs. While integrating these two EIIs in outpatient clinics aligns with federal priorities, most clinicians in these settings do not offer them, even when providing addiction treatment. Modeling shows that when outpatient clinics prescribe injection equipment, SIRI-related hospitalizations reduce by 30%, and when they prescribe PrEP, it increases uptake among PWID. However, gaps remain in how to effectively implement the prescribing of injection equipment and PrEP in these settings.

Prescribe to Prevent HIV, is a participatory study to co-create and pilot a tailored strategy bundle for prescribing injection equipment and PrEP in four Pennsylvania Centers of Excellence in Opioid Use Disorders (COEs). Our approach combines implementation science with human-centered design, engaging a collaborative of individuals with lived experience, clinicians, and organizations serving PWID throughout all study phases to ensure relevance and sustainability.

First, we will develop a strategy bundle by identifying implementation barriers and facilitators through 24 semi-structured interviews with COE patients, administrators, clinicians, and staff, guided by the Consolidated Framework for Implementation Research and informed by input from a community collaborative of individuals with lived experience. Then, using a human-centered design process, we will co-create a tailored, practical, and adaptable strategy bundle based on findings from the semi-structured interviews, insights from the community collaborative, and input gathered through four focus groups-one each with COE patients, clinicians, staff, and administrators-for implementation across the four COE sites.

Then we will conduct a cluster randomized, waitlist-controlled hybrid type 3 implementation-effectiveness pilot trial at 4 COEs of an implementation strategy bundle for prescribing injection equipment and PrEP in outpatient clinics. We will assess primary implementation outcomes of site-level adoption and maintenance of proportion of clinicians prescribing injection equipment and/or PrEP, measured at the end of the 6-month implementation period (adoption), and at 12 months (maintenance). Secondary outcomes will include patient-level SIRI-related hospitalizations and negative HIV tests.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Study Start: 2025-07-30
• Primary Completion: 2027-12
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 536

Inclusion Criteria

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

Exclusion Criteria

• Ages <18
• If history of injection drug use >1 year
• Non-English speaking
• Pending or legal action that could prohibit or interfere with participation (Ie. incarceration)
• Residence or discharge to a treatment facility that bans the possession of drug checking supplies
• Acute, severe psychiatric condition in need of immediate treatment.

Clinical Partners:

Pre-implementation interviews (N=12), pre-implementation focus groups (N = 24), post-implementation surveys (N = 80), and post-implementation interviews (N=10)

Inclusion Criteria:

-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:

• Individuals not affiliated with the 4 COEs.
• Staff outside the specified roles (i.e., not prescribing clinicians, administrators, medical assistants, or nurses).
• Students, trainees, or individuals not credentialed in the eligible roles.
• Those on extended leave or not actively working during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Implementation Outcomes	6 months post implementation	Acceptability: Acceptability of the implementation strategy bundle will be assessed via post-implementation surveys of participating clinical partners (N=60-80) using a reliable 4-item survey from Weiner et al., where scores ≥16 indicate "acceptable" if 80% of participants agree.

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes	6 months pre-implementation and 6 months post-implementation	Rate of negative HIV tests. We will assess the rate of negative HIV screening tests by extracting electronic health record data from participating sites using which will be collected as part of routine clinical care.

Trial Locations

Locations (4)

Latterman Family Health Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Center for Psychiatric And Chemical Dependency Services; 🇺🇸 Pittsburgh, Pennsylvania, United States

Internal Medicine Recovery Engagement Program; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States