Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support

NCT07073924 | Not Yet Recruiting

• 2 other identifiers: STUDY25050118K23DA063654
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 4

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.

Conditions

People Who Use Opioids/People With Opioid Use Disorder (OUD)

Keywords

people who use drugs; HIV; PrEP; Opioid-Related Disorders; implementation; Substance-Related Disorders

Outcome Measures

Primary Outcomes (3)

• Implementation Outcomes: Site Level Adoption

  This is defined as the proportion of clinicians who prescribed injection equipment and/or PrEP per site, assessed at 6 months post-implementation, respectively using electronic health record data.

  6 months post implementation

• Implementation Outcomes: Site-level maintenance

  This is defined as the proportion of clinicians who prescribed injection equipment and/or PrEP per site, assessed at 12 months post-implementation respectively using electronic health record data.

  12 months post implementation

• Implementation Outcomes: Acceptability of the strategy bundle

  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.

  6 months post implementation

Secondary Outcomes (2)

• Clinical Outcome: Rate of SIRI-related hospitalizations

  6 months pre-implementation and 6 months post-implementation

• Clinical Outcome: Rate of negative HIV tests

  6 months pre-implementation and 6 months post-implementation

Study Arms (2)

Intervention Arm

OTHER

Immediately gets the intervention of the implementation strategy bundle.

Behavioral: Implementation strategy bundle

Waitlist Control Arm

OTHER

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

Behavioral: Implementation strategy bundle

Interventions

Implementation strategy bundle BEHAVIORAL

The anticipated strategy bundle will include integrated patient-, provider-, and system-level interventions to support sustainable implementation. At the patient level, this may involve education, peer support, and navigation services; at the provider level, training, decision-support tools, and workflow enhancements; and at the system level, policy changes, electronic health record integration, and organizational alignment to promote and maintain prescribing of PrEP and injection equipment.

Intervention Arm; Waitlist Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Latterman Family Health Center

Pittsburgh, Pennsylvania, 15132, United States

Location

Center for Psychiatric And Chemical Dependency Services

Pittsburgh, Pennsylvania, 15213, United States

Location

Internal Medicine Recovery Engagement Program

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Raagini Jawa, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raagini Jawa, MD, MPH

CONTACT

(412) 232-6275; rjawa@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Cluster randomized, waitlist-controlled hybrid type 3 implementation-effectiveness pilot trial

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 20, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Data will only be shared with external investigators when a data use agreement (DUA) is executed between University of Pittsburgh and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data.

Locations

US (4)