An interventional study of E-consult in HIV, Inhaled Corticosteroid and Proton Pump Inhibitor, sponsored by Seattle Institute for Biomedical and Clinical Research. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Seattle Institute for Biomedical and Clinical Research · Not applicable, Interventional, and Health services research
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.
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.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 480 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Seattle Institute for Biomedical and Clinical Research is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
PWH with an active prescription of ART any time in past 6 months and \<200 copies/mL within past 12 months, actively receiving care at the VA, and one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV+ Patients in this arm will receive usual care from their provider
HIV+ patients randomized into in this arm will have proactive E-consults with pharmacist recommendations sent to enrolled providers prior to appointments
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
Proportion of recommended medication changes enacted 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.
Time frame: Within 3 months
Proportion of vaccine recommendations enacted.
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.
Time frame: Within 3 months
Proportion of medication recommendations enacted or later rescinded.
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.
Time frame: 12 months
Proportion of vaccine recommendations enacted.
Same methods as within 3 months.
Time frame: 12 months
Changes in smoking status.
VA EHR health factors data with chart review confirmation as needed.
Time frame: 12 months
Events such as pneumonia, COPD exacerbation, gastrointestinal bleeding, hospitalization, and other adverse events.
VA EHR ICD codes, hospital discharge summaries, payment data (for non-VA hospitalizations) with chart review confirmation as needed.
Time frame: 12 months
Changes in smoking cessation pharmacotherapy, inhaled corticosteroids, proton pump inhibitors made by providers that were not part of E- consult recommendations.
VA EHR pharmacy data.
Time frame: 12 months
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Seattle Institute for Biomedical and Clinical Research