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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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