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. This study is supported by the HEAL Initiative (https://heal.nih.gov/).
None
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)
Sequential
Implementation strategy bundle
BehavioralThe 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.
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.
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.
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.
Clinical Outcome: Rate of SIRI-related hospitalizations
We will assess the rate of SIRI-related hospitalizations by extracting electronic health record data from participating sites using an established search algorithm that identifies relevant cases through ICD-10 codes associated with injection drug use infections.
Clinical Outcome: 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.
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University of Pittsburgh
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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