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

NCT07507435 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • HIV
  • Inhaled Corticosteroid
  • Proton Pump Inhibitor
  • Smoking Cessation
  • Pneumonia

Interventions

OTHER

E-consult

Pharmacist-driven e-consults to providers of people with HIV (PWH) to improve guideline-concordant care and decrease population risk of pneumonia in PWH

Sponsors & Collaborators

  • VA Puget Sound Health Care System

    collaborator FED
  • Minneapolis Veterans Affairs Medical Center

    collaborator FED
  • Boise VA Medical Center

    collaborator FED
  • West Haven VA Medical Center

    collaborator UNKNOWN
  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Kristina A. Crothers, MD · VA Puget Sound Health Care System

  • Ken M Kunisaki, MD,MS · Boise VA Medical Center

  • Orly Vardeny, PharmD · Minneapolis Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-03-31
Completion
2029-09-30

Countries

  • United States

Study Locations

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Entities

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 NCT07507435 on ClinicalTrials.gov