This clinical trial aims to improve the current knowledge on how best to deliver smoking cessation interventions for people living with human immunodeficiency virus (HIV). Lung cancer is now the leading cause of cancer death among individuals infected with HIV. Tobacco use is a major contributing factor to lung cancer incidence and mortality. With several effective tobacco treatment approaches at the patients’ disposal, optimizing how those treatments are delivered to people living with HIV requires assessment. Prior studies demonstrated that presenting tobacco treatment in an opt-out (as opposed to opt-in) fashion results in increased patient reach and likelihood of abstinence. This trial evaluates the impact of a proactive, opt-out smoking cessation intervention on cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. Integrating effectiveness and implementation results from this trial will help define best practices for engaging individuals infected with HIV with evidence-based tobacco treatment intervention.
Additional locations may be listed on ClinicalTrials.gov for NCT05019495.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Alana M Rojewski
Phone: 843-876-1593
Mc Bee
Sandhills Medical FoundationStatus: Active
Contact: Alana M Rojewski
PRIMARY OBJECTIVE:
I. To conduct a randomized clinical trial with people living with HIV (PWH) who smoke (N=230) comparing smoking cessation outcomes consistent with the RFA including: biochemically verified 7-day point prevalence abstinence (PPA) rates, continuous abstinence (weeks 9-12), and the number of 24-hour quit attempts at the end of study treatment (week 12) between participants who receive TAU and Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE).
SECONDARY OBJECTIVE:
I. To characterize key determinants of PrOMOTE implementation outcomes using a mixed methods approach.
EXPLORATORY OBJECTIVES:
I. To compare CD4 cell count and HIV viral load (HIV RNA) between those who achieved abstinence and those who continue to smoke from baseline to Week 24 follow-up.
II. To assess the durability of PrOMOTE as compared to TAU on abstinence and quit attempt measures at the 6-month follow up visit (Week 24).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive standard referral for infectious disease clinical pharmacist for medication management. Patients who see the clinical pharmacist and are current smokers interested in quitting smoking, are prescribed pharmacotherapy. Patients also may undergo saliva sample collection during screening and undergo blood sample collection during follow-up.
GROUP II: Patients receive smoking cessation counseling from clinical pharmacist. Patients also receive prescription for pharmacotherapy (varenicline or dual nicotine replacement therapy [NRT]). Patients who opt-out of pharmacotherapy, participate in a brief motivational interview with clinical pharmacist to encourage the use of smoking cessation pharmacotherapy. Patients also may undergo saliva sample collection during screening and undergo blood sample collection during follow-up.
After completion of study, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationMedical University of South Carolina
Principal InvestigatorAlana M Rojewski
