Smoking CessationNCT07501624
Engaging Pharmacists to Advance Tobacco Treatment Service Delivery
A study testing ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS) in people with Smoking Cessation and Tobacco Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking Cessation, Tobacco Use Disorder, Smoking
- What is being tested?
- ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2026to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1) currently imprisoned.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Tobacco Use Disorder, Smoking, HIV, AIDS, Pharmacy
- Being tested
- ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Smoking, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From Study Start (Pre-Implementation Period) to Study Completion (Post-Implementation Period) (approximately 4 year study period)
Secondary outcomes (1)
Smoking Abstinence
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.
Measured: 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start11 Feb 2026
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge design with sites randomized to start date
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Alana Rojewski, Medical University of South Carolina
- Investigators
- Alana Rojewski, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501624
- Sponsor's protocol ID
- Pro00142041
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be shared in summary format with clinics; individual-level data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Pharmacists to Advance Tobacco Treatment Service Delivery for People Living With HIV
- ClinicalTrials.gov ID
- NCT07501624
- Acronym / sponsor ID
- Pro00142041
- Conditions
- Smoking Cessation, Tobacco Use Disorder, Smoking, HIV, AIDS, Pharmacy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped wedge design with sites randomized to start date
| Arm | Type | Receives |
|---|---|---|
| ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS) | Experimental | 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1) currently imprisoned.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS) |
Primary outcome
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).
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.
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).
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).
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.
1 secondary outcome
Smoking Abstinence
Time frame: 3- and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. Results will be shared in summary format with clinics; individual-level data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alana Rojewski, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS) in people with Smoking Cessation and Tobacco Use Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of the Intervention (time frame: From baseline clinic engagement to 12 months following program launch). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.