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Enrolling by Invitation

NCT Number: NCT07501624

Engaging Pharmacists to Advance Tobacco Treatment Service Delivery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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

Exclusion:

  • currently imprisoned.

Treatment and study plan

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).

Primary outcomes

  1. 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).

  2. 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. 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).

  4. 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).

  5. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 30, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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