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

NCT07073924 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2026-03-04

No results posted yet for this study

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)

Interventions

BEHAVIORAL

Implementation strategy bundle

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Raagini Jawa, MD, MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07073924 on ClinicalTrials.gov