Recruiting

Tobacco Treatment

Sponsor:

Medical University of South Carolina

Code:

NCT05019495

Conditions

Hiv

Smoking, Cigarette

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

PrOMOTE

Study Details

Brief summary:

The purpose of this study is to conduct a randomized trial to evaluate a proactive, opt-out model of provider contact to deliver smoking cessation support for people living with HIV compared to standard care support delivered through traditional clinic pathways. Investigators will also evaluate implementation outcomes to identify barriers and facilitators towards future implementation. Investigators hope to define best practices and optimize the delivery of smoking cessation interventions for people living with HIV.

Conditions

Hiv

Smoking, Cigarette

Study ID

NCT05019495

Start date

Dec 1, 2021

Status verified date

Jan, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 21 and older
  • Current diagnosis of HIV
  • Current smoker (defined as self-report of current smoking)
  • Willing to be randomized
  • English speaking

Exclusion Criteria:

  • Currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking nicotine replacement therapy or other cessation medications, enrolled in the Quitline, or in another study)
  • Currently imprisoned
  • Pregnant women
  • Non-English speaking persons

Study Design

Enrollment

231 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Treatment as Usual

Treatment as Usual (TAU) participants will follow traditional clinic pathways for receiving tobacco treatment in the Medical University of South Carolina Health Infectious Disease outpatient clinic. All patients randomized to TAU will have the opportunity to access smoking cessation pharmacotherapy from the Infectious Disease clinical pharmacist.

experimental: ProMOTE

In the PrOMOTE group, the participants will be contacted by the clinical pharmacist on the tobacco treatment staff three times for medication prescriptions and refills. They will also receive brief counseling and motivational interviewing by the clinical pharmacist.

Interventions

PrOMOTE

This is an opt-out, proactive approach to tobacco treatment by a clinical pharmacy specialist. The pharmacist will call patients and offer an individualized pharmacotherapy prescription. The patient must opt-out for it not to be sent to their pharmacy. The patient will also receive brief motivational interviewing and behavioral counseling from the pharmacist.

Primary outcome measure

  • Tobacco use abstinence [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Chloe Morone

843-637-0734morone@musc.edu

Alana Rojewski

8438761593rojewski@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Chloe Morone

843-637-0734

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Keywords

  • Smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-01-06.