Optimizing Tobacco Treatment Delivery for People Living With HIV

Not Applicable

Recruiting

• Conditions: Hiv; Smoking, Cigarette
• Interventions: Behavioral: PrOMOTE

• Registration Number: NCT05019495
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Study Start: 2021-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2027-01-01
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 231

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProMOTE	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.

Primary Outcome Measures

Name	Time	Method
Tobacco use abstinence	7 days	Self-reported and confirmed by breath carbon monoxide test

Secondary Outcome Measures

Name	Time	Method
Reach	24 weeks (study completion)	Percentage of current smokers engaged in an intervention
Acceptability of intervention	24 weeks (study completion)	The perception among stakeholders that the treatment is agreeable or satisfactory. This will be collected via surveys.
Fidelity of intervention	24 weeks (study completion)	The extent to which an intervention is implemented as intended. This will be collected via surveys.
Perceived barriers to the outcomes	24 weeks (study completion)	Using the implementation tracking checklist, provider perceptions of barriers faced in completion of intervention steps will be monitored. These will be collected via interviews with providers.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States