Engaging Pharmacists to Advance Tobacco Treatment Service Delivery

March 30, 2026 updated by: Alana Rojewski, Medical University of South Carolina

Engaging Pharmacists to Advance Tobacco Treatment Service Delivery for People Living With HIV

This research will test the effects of a novel program (ENHANCE-TTS) with tools, training, and clinic facilitation support that capitalizes on pharmacists' roles by expanding their scope of practice to deliver tobacco treatment. This effectiveness-implementation study will evaluate the effects of the ENHANCE-TTS program on implementation outcomes and patient-level smoking cessation outcomes in people living with HIV and concurrently identify key barriers and facilitators to implementing this program in practice.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The overall goal of this research is to improve care for people living with HIV through the delivery of high-quality tobacco treatment to address the high rates of smoking in this population. This research will test the effects of a novel program on pharmacists' roles by expanding their scope of practice to deliver tobacco treatment. Investigators will evaluate provider- and patient-level outcomes.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Pharmacist, Clinic Administrator, and Patient Advocate inclusion criteria:

Pharmacists, Clinic Administrators, and Patient Advocates from each of 6 Ryan White clinics who agree to participate in the study.

Clinic patient inclusion criteria:

  1. age 21 and older
  2. current diagnosis of HIV
  3. completed at least 1 visit with the clinical pharmacist for tobacco treatment, 4) English speaking;

Exclusion:

1) currently imprisoned.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)
The ENHANCE-TTS program includes team-building at each clinic, pharmacist training, facilitation (i.e., infrastructure planning for systems change, problem-solving, and coaching) and tools (clinic roadmap, readiness assessment, training workbook).
Behavioral: ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)
The ENHANCE-TTS program includes team-building at each clinic, pharmacist training, facilitation (i.e., infrastructure planning for systems change, problem-solving, and coaching) and tools (clinic roadmap, readiness assessment, training workbook).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adoption of the Intervention
Time Frame: From baseline clinic engagement to 12 months following program launch
Adoption is characterized as pharmacists' tobacco treatment care delivery adoption (comparing pre-implementation to post-implementation rates of tobacco use disorder diagnosis codes entered, tobacco treatment pharmacotherapy prescriptions written [e.g., varenicline], and tobacco treatment counseling codes entered).
From baseline clinic engagement to 12 months following program launch
Acceptability of the Intervention
Time Frame: 3-Month Implementation Period
We will measure acceptability at the provider level via the 4-item Acceptability of Intervention Measure (AIM) and a training satisfaction survey.
3-Month Implementation Period
Fidelity to the Intervention
Time Frame: Implementation Period Through Study Completion (approximately 4 year study period)
Fidelity at the clinic level is defined as the percentage of total program launch and implementation steps completed (i.e., kick-off, infrastructure build, training, coaching calls and systems change). Fidelity at the provider level is defined as the percentage of assessment and counseling steps completed (assessment of smoking history and current dependence, environmental triggers for smoking, pharmacotherapy options, and behavioral strategies for coping with urges to smoke).
Implementation Period Through Study Completion (approximately 4 year study period)
Cost to Implement the Intervention
Time Frame: 3-Month Implementation Period
Cost is defined as costs to deliver the intervention (e.g., the sum of the costs of the TTS training, travel, hours of consultation participation and number of staff included, training and technical assistance).
3-Month Implementation Period
Penetration of the Intervention
Time Frame: From Study Start (Pre-Implementation Period) to Study Completion (Post-Implementation Period) (approximately 4 year study period)
Penetration of the intervention is defined as the total number of counseling appointments delivered over the total number of smoking patients and the pace of completed counseling appointments over the Implementation period compared to the Pre-Implementation period.
From Study Start (Pre-Implementation Period) to Study Completion (Post-Implementation Period) (approximately 4 year study period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Abstinence
Time Frame: 3- and 6-month follow-up
Abstinence will be defined as self-reported 7-day point prevalence abstinence confirmed by breath carbon monoxide (CO). We will ask participants during follow-up, "Have you smoked a cigarette or used any type of combustible tobacco products in the past 7 days?" An answer of "no," coupled with a breath CO ≤5 ppm, will be considered abstinence.
3- and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Alana Rojewski, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00142041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will be shared in summary format with clinics; individual-level data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe