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NCT Number: NCT07507435

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

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.

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Key information

Conditions

HIV Behavior Health Behavior Infections Inhaled Corticosteroid Lung Diseases Pneumonia Proton Pump Inhibitor Respiratory Tract Diseases Respiratory Tract Infections Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boise VA Medical Center, Boise, Idaho, United States

Loading trial locations.

About this study

Despite reductions in opportunistic infections, PWH remain at significantly higher risk for community-acquired pneumonia than people without HIV, with increased susceptibility to pneumococcal disease, influenza hospitalization, and COVID-19-related complications. Pneumonia in PWH leads to substantial short- and long-term consequences, including respiratory failure, cardiovascular events, cognitive decline, and worsening of chronic lung disease. Several pneumonia risk factors are common yet modifiable, including cigarette smoking, inappropriate ICS and PPI use, and missed respiratory vaccinations.

Proactive E-consults have proven effective in improving COPD care for PWH in prior work by our group (ACHIEVE). OPTIMIZE adapts this approach by shifting E-consult delivery from pulmonologists to clinical pharmacists, who are already integrated into primary and specialty care workflows within the Veterans Health Administration. Pharmacists will use a structured review process to identify opportunities for smoking cessation pharmacotherapy, deprescribing of ICS or PPIs, and respiratory vaccination updates. Recommendations will be communicated through a BLUF-formatted E-consult with pre-entered orders to reduce provider burden while preserving provider autonomy.

The trial uses a randomized design in which completed pharmacist reviews are allocated 1:1 to intervention or usual care. Providers in the intervention arm receive the E-consult before the patient visit; those in the usual care arm do not. Outcome assessors will be blinded.

In addition to measuring clinical effectiveness, the study will conduct interviews and surveys with HIV providers, implementation stakeholders, and patients to understand determinants of successful implementation and potential for wider dissemination. Findings will inform scalability of pharmacist-led proactive E-consults across the VHA and other learning health systems.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PWH on ART for 6 months, receiving care at the VA, and one or more of the following:
  • Actively smoking
  • Prescribed ICS for >90 days
  • Prescribed a PPI for >90 days

Exclusion criteria

  • Enrolled in palliative care or hospice
  • if a non-VA provider is the main primary care or HIV provider
  • Are currently participating in a separate ongoing interventional clinical trial

Treatment and study plan

E-consult

Other

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

Primary outcomes

  1. Proportion of recommended medication changes enacted within 3 months

    Time frame: Within 3 months

    Numerator = Number of recommended medication changes ordered (by provider) and filled (by patient).

    Denominator = Number of medication changes recommended by pharmacist E-consult. Outcomes extracted by data query from VA Electronic Health Record (EHR) pharmacy data.

Secondary outcomes

  1. Proportion of vaccine recommendations enacted.

    Time frame: Within 3 months

    Numerator = Number of recommended vaccines received by the patient Denominator = Number of vaccines recommended by pharmacist E-consult. Outcomes extracted by VA EHR data and confirmed by chart review.

  2. Proportion of medication recommendations enacted or later rescinded.

    Time frame: 12 months

    Same methods as primary outcome. Will assess later enactment of initial recommendations not completed within first 3 months of E-consult and resumption of initially deprescribed medications.

  3. Proportion of vaccine recommendations enacted.

    Time frame: 12 months

    Same methods as within 3 months.

  4. Changes in smoking status.

    Time frame: 12 months

    VA EHR health factors data with chart review confirmation as needed.

  5. Events such as pneumonia, COPD exacerbation, gastrointestinal bleeding, hospitalization, and other adverse events.

    Time frame: 12 months

    VA EHR ICD codes, hospital discharge summaries, payment data (for non-VA hospitalizations) with chart review confirmation as needed.

  6. Changes in smoking cessation pharmacotherapy, inhaled corticosteroids, proton pump inhibitors made by providers that were not part of E- consult recommendations.

    Time frame: 12 months

    VA EHR pharmacy data.

Study contacts

Contact information is provided by the study sponsor or research team.

John R Kundzins, BS

CONTACT

[email protected]

206-277-1182

Sponsors and collaborators

Lead sponsor

Seattle Institute for Biomedical and Clinical Research

Other

Collaborators

  • Boise VA Medical Center
  • Minneapolis Veterans Affairs Medical Center
  • VA Puget Sound Health Care System
  • West Haven VA Medical Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 2, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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