Recruiting

Pharmacist-Led Intervention

Sponsor:

Seattle Institute for Biomedical and Clinical Research

Code:

NCT07507435

Conditions

HIV

Inhaled Corticosteroid

Proton Pump Inhibitor

Smoking Cessation

Pneumonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

E-consult

Study Details

Brief 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

Study ID

NCT07507435

Start date

Sep 24, 2026

Status verified date

Nov, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. Actively smoking
2. Prescribed ICS for >90 days
3. 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

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: No Intervention: Usual care

HIV+ Patients in this arm will receive usual care from their provider

other: Proactive E-consult

HIV+ patients randomized into in this arm will have proactive E-consults with pharmacist recommendations sent to enrolled providers prior to appointments

Interventions

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

Primary outcome measure

  • Proportion of recommended medication changes enacted within 3 months [ Time Frame: Within 3 months ]

Central Contacts and Locations

Central contacts

Locations

VA Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

More Information

Sponsor

Seattle Institute for Biomedical and Clinical Research

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Keywords

  • Pharmacist
  • E-consult
  • HIV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Seattle Institute for Biomedical and Clinical Research on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.