Clinical Trial

Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults

Not Yet Recruiting
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Summary
People with HIV (PWH) continue to experience elevated risk of community-acquired pneumonia despite effective antiretroviral therapy. Pneumonia contributes to hospitalization, respiratory failure, cardiovascular complications, long-term decline in lung function, and mortality. Several modifiable factors increase this risk, including active smoking, inadequate receipt of respiratory vaccinations, and inappropriate or prolonged use of inhaled corticosteroids (ICS) or proton-pump inhibitors (PPIs). OPTIMIZE Lung-HIV is a multicenter, patient-level randomized controlled hybrid Type 1 effectiveness-implementation trial evaluating whether a proactive, pharmacist-led E-consult intervention can improve evidence-based pulmonary pharmacotherapy for PWH. Pharmacists will review electronic health records, generate tailored recommendations, and pre-enter orders related to smoking cessation pharmacotherapy, vaccinations, and deprescribing of ICS or PPIs. Providers may enact or modify recommendations as clinically appropriate. The trial will assess the proportion of recommendations enacted within 3 months (primary outcome) and at 12 months (maintenance) and will use mixed methods guided by CFIR and RE-AIM to evaluate adoption, feasibility, acceptability, and implementation barriers and facilitators.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-26.
Trial Details
NCT Number NCT07507435
Lead Sponsor Seattle Institute for Biomedical and Clinical Research
Collaborators: VA Puget Sound Health Care System, Minneapolis Veterans Affairs Medical Center, Boise VA Medical Center, West Haven VA Medical Center
Conditions HIV, Inhaled Corticosteroid, Proton Pump Inhibitor, Smoking Cessation, Pneumonia
Enrollment 480 participants
Start Date 2026-08
Primary Completion 2029-03 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-07