Optimizing Tobacco Treatment Delivery for People Living With HIV

NCT ID: NCT05019495

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2027-02-28

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.

Detailed Description

This hybrid effectiveness-implementation trial presents on opportunity to optimize tobacco treatment delivery for people living with HIV (PLWH), and identify barriers and facilitators towards future implementation. We are proposing a comparison of Treatment As Usual (TAU; reactive, opt-in tobacco treatment using standard clinical pathways) vs Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Participants will be randomized in a 1:1 allocation. The primary aim is to compare rates of cessation and quit attempts at the Week 12 follow-up between participants who received TAU versus PrOMOTE. As a secondary aim we will characterize key determinants of PrOMOTE reach, implementation fidelity, adherence, and acceptability. We hypothesize that the PrOMOTE intervention will increase cessation rates and number of quit attempts, and that it will result in greater reach and pharmacotherapy delivery compared to TAU. Key determinants of PrOMOTE implementation outcomes will also be characterized. An exploratory assessment of CD4 cell count and HIV viral load, in addition to durability of smoking cessation outcomes, will also be assessed. By optimizing the delivery of effective tobacco treatments for PLWH, we hope to increase the number of people receiving tobacco treatment, increase tobacco cessation rates, and reduce the risk of morbidity and mortality from smoking-related causes.

Conditions

Hiv; Smoking, Cigarette

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

PrOMOTE

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Alana Rojewski

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chloe Morone

Role: CONTACT

morone@musc.edu

843-637-0734

Alana Rojewski

Role: CONTACT

rojewski@musc.edu

8438761593

Facility Contacts

Chloe Morone

Role: primary

843-637-0734

References

Sanford BT, Toll BA, Eckard AR, Sterba KR, Cummings KM, Baker NL, Rojewski AM. Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial. Addict Sci Clin Pract. 2022 Nov 5;17(1):61. doi: 10.1186/s13722-022-00341-2.

Reference Type: DERIVED

PMID: 36335376 (View on PubMed)

Other Identifiers

R01CA261232

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00107332

Identifier Type: -

Identifier Source: org_study_id