Optimizing Tobacco Treatment Delivery for People Living With HIV

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.

Study Overview

• Status: Recruiting
• Conditions: Hiv; Smoking, Cigarette
• Intervention / Treatment: Behavioral: PrOMOTE

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 Type: Interventional
• Enrollment (Estimated): 231
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline G Foster; Phone Number: 8437371516; Email: fostemad@musc.edu
• Study Contact Backup: Name: Alana Rojewski; Phone Number: 8438761593; Email: rojewski@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Madeline Foster; Phone Number: 843-737-1516

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco use abstinence	Self-reported and confirmed by breath carbon monoxide test	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	Percentage of current smokers engaged in an intervention	24 weeks (study completion)
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)
Fidelity of intervention	The extent to which an intervention is implemented as intended. This will be collected via surveys.	24 weeks (study completion)
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)
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)
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)
Acceptability of intervention	The perception among stakeholders that the treatment is agreeable or satisfactory. This will be collected via surveys.	24 weeks (study completion)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 23, 2025

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Smoking
• Other Study ID Numbers: 00107332; R01CA261232 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No