Optimizing Tobacco Treatment Delivery for People Living With HIV

Hiv Clinical Trial

Official title:

Optimizing Tobacco Treatment Delivery for People Living With HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019495
• Other study ID #: 00107332
• Secondary ID: R01CA261232
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 23, 2025

Study information

• Verified date: November 2023
• Source: Medical University of South Carolina
• Contact: Madeline G Foster
• Phone: 8437371516
• Email: fostemad[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 231
• Est. completion date: December 23, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Smoking, Cigarette

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use abstinence	Self-reported and confirmed by breath carbon monoxide test	7 days
Secondary	Reach	Percentage of current smokers engaged in an intervention	24 weeks (study completion)
Secondary	Fidelity of intervention	The extent to which an intervention is implemented as intended. This will be collected via interviews with patients and providers.	24 weeks (study completion)
Secondary	Fidelity of intervention	The extent to which an intervention is implemented as intended. This will be collected via surveys.	24 weeks (study completion)
Secondary	Perceived barriers to the outcomes	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 patients.	24 weeks (study completion)
Secondary	Perceived barriers to the outcomes	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.	24 weeks (study completion)
Secondary	Acceptability of intervention	The perception among stakeholders that the treatment is agreeable or satisfactory. This will be collected via interviews with patients and providers.	24 weeks (study completion)
Secondary	Acceptability of intervention	The perception among stakeholders that the treatment is agreeable or satisfactory. This will be collected via surveys.	24 weeks (study completion)