NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07073924

Not Yet RecruitingNA

Sponsor: University of Pittsburgh

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

Interventions: Implementation strategy bundle

Countries: United States

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/).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Patients:

Pre-implementation interviews (N=12), pre-implementation focus groups (N=8), and post-implementation interviews (N=10)

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.

Locations (4)

Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States