HIVNCT07507435
Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults
A study testing E-consult in people with HIV and Inhaled Corticosteroid, run by Seattle Institute for Biomedical and Clinical Research at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Inhaled Corticosteroid, Proton Pump Inhibitor
- What is being tested?
- E-consult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Actively smoking
- Prescribed ICS for >90 days
- Prescribed a PPI for >90 days
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Boise VA Medical Center
Boise, Idaho, 83702
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults (OPTIMIZE Lung-HIV)
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.
Read the detailed description
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.
- Conditions
- HIV, Inhaled Corticosteroid, Proton Pump Inhibitor, Smoking Cessation, Pneumonia
- Being tested
- E-consult
- Keywords
- Pharmacist, E-consult, HIV
- Medical subject headings
- Smoking Cessation, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-consultOther
Pharmacist-driven e-consults to providers of people with HIV (PWH) to improve guideline-concordant care and decrease population risk of pneumonia in PWH
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Usual care | No intervention | HIV+ Patients in this arm will receive usual care from their provider |
| Proactive E-consult | Other | HIV+ patients randomized into in this arm will have proactive E-consults with pharmacist recommendations sent to enrolled providers prior to appointments Receives: Other: E-consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 12 months
Proportion of vaccine recommendations enacted.
Same methods as within 3 months.
Measured: 12 months
Changes in smoking status.
VA EHR health factors data with chart review confirmation as needed.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Minneapolis Veterans Affairs Medical Center, Boise VA Medical Center, West Haven VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Kristina A. Crothers, MD, Principal investigator, VA Puget Sound Health Care SystemKen M Kunisaki, MD,MS, Principal investigator, Boise VA Medical CenterOrly Vardeny, PharmD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507435
- Sponsor's protocol ID
- 1R01HL179905-01
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults (OPTIMIZE Lung-HIV)
- ClinicalTrials.gov ID
- NCT07507435
- Acronym / sponsor ID
- 1R01HL179905-01
- Conditions
- HIV, Inhaled Corticosteroid, Proton Pump Inhibitor, Smoking Cessation, Pneumonia
- Keywords
- Pharmacist, E-consult, HIV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Minneapolis Veterans Affairs Medical Center, Boise VA Medical Center, West Haven VA Medical Center
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Usual care | No intervention | –HIV+ Patients in this arm will receive usual care from their provider |
| Proactive E-consult | Other | Other: E-consultHIV+ patients randomized into in this arm will have proactive E-consults with pharmacist recommendations sent to enrolled providers prior to appointments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-consultPharmacist-driven e-consults to providers of people with HIV (PWH) to improve guideline-concordant care and decrease population risk of pneumonia in PWH | Other | Proactive E-consult |
Primary outcome
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.
6 secondary outcomes
Proportion of vaccine recommendations enacted.
Time frame: Within 3 months
Proportion of medication recommendations enacted or later rescinded.
Time frame: 12 months
Proportion of vaccine recommendations enacted.
Time frame: 12 months
Changes in smoking status.
Time frame: 12 months
Events such as pneumonia, COPD exacerbation, gastrointestinal bleeding, hospitalization, and other adverse events.
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.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristina A. Crothers, MD principal investigator
VA Puget Sound Health Care System
Ken M Kunisaki, MD,MS principal investigator
Boise VA Medical Center
Orly Vardeny, PharmD principal investigator
Minneapolis Veterans Affairs Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-consult in people with HIV and Inhaled Corticosteroid, run by Seattle Institute for Biomedical and Clinical Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John R Kundzins, BS (206-277-1182, OPTIMIZEStudyTeam@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of recommended medication changes enacted within 3 months (time frame: Within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.