Engaging Pharmacists to Advance Tobacco Treatment Service Delivery

NCT07501624 | Enrolling By Invitation

• 1 other identifier: Pro00142041
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Tobacco Use Disorder; Smoking; HIV; AIDS; Pharmacy

Outcome Measures

Primary Outcomes (5)

• Adoption of the Intervention

  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

  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

  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

  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

  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 Outcomes (1)

• Smoking Abstinence

  3- and 6-month follow-up

Study Arms (1)

ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)

EXPERIMENTAL

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)

Interventions

ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS) BEHAVIORAL

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).

ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pharmacists and Clinic Administrators from each of 6 Ryan White clinics who agree to participate in the study.
• age 21 and older
• current diagnosis of HIV
• completed at least 1 visit with the clinical pharmacist for tobacco treatment, 4) English speaking;

You may not qualify if:

• \) currently imprisoned.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Smoking; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Alana Rojewski, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Model Details: Stepped wedge design with sites randomized to start date

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 30, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)