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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07073924
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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/).

Key Dates

Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
536 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Other: Intervention Arm
    Immediately gets the intervention of the implementation strategy bundle.
  • Other: Waitlist Control Arm
    Waits for 6 months with no intervention, then gets the intervention of the implementation strategy bundle.

Primary Outcome Measure

Implementation Outcomes: Site Level Adoption [ Time Frame: 6 months post implementation ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Center for Psychiatric And Chemical Dependency ServicesPittsburghPennsylvania15213
Megan Ganung
[email protected]
(412) 246-5910
Internal Medicine Recovery Engagement ProgramPittsburghPennsylvania15213
Ariana Freund
[email protected]
(412) 232-6275
Latterman Family Health CenterPittsburghPennsylvania15132
Hannah Scears
[email protected]
(412) 673-5504
UPMC Magee-Womens HospitalPittsburghPennsylvania15213
Ilana Hull, MD
[email protected]
412-530-6154

Find similar trials in Pittsburgh, PA

By research site
Center for Psychiatric And Chemical Dependency Services· Pittsburgh, PAInternal Medicine Recovery Engagement Program· Pittsburgh, PALatterman Family Health Center· Pittsburgh, PAUPMC Magee-Womens Hospital· Pittsburgh, PA

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