NCT04949464

Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV quit smoking.

Detailed description

PRIMARY OBJECTIVES: I. Determine the feasibility of a smartphone-based human immunodeficiency virus (HIV)-specific behavioral smoking cessation intervention that can be delivered at the time of low dose non contrast enhanced lung computed tomography (LDCT), as measured by use of and engagement with the intervention. II. Determine the adherence to LDCT in a study setting for persons living with HIV (PLWH) who smoke. SECONDARY OBJECTIVES: I. Determine the prevalence of positive LDCT screens and related follow-up procedures (which may include any of the following: follow-up computed tomography \[CT\] scan at an interval less than 12 months from the screening LDCT; (2) positron emission tomography (PET) with or without CT scan; (3) transthoracic needle biopsy; (4) bronchoscopy, with or without biopsy; (5) surgical biopsy and/or resection) in PLWH who smoke. II. Quantify the proportions of persons who quit smoking at 3 and 6 months after using the HIV-specific smoking cessation intervention and receiving LDCT screening. III. Obtain preliminary estimate of the proportion of participants who use prescribed nicotine replacement (self-reported) at 3-month visit. EXPLORATORY OBJECTIVES: I. Identify characteristics associated with PLWH who smoke who are more likely to engage with an HIV-specific smoking cessation intervention. II. Quantify LDCT screening-related study endpoints (i.e. incident lung cancers, emphysema, and other incidental findings in PLWH who smoke. III. Compare LDCT screening-relevant patient reported outcomes (anxiety, insomnia, pain) at 3 and 6 months after LDCT to evaluate screening tolerability. OUTLINE: Patients use the smartphone application, Positively Smoke Free - Mobile, for 42 days. Patients also receive nicotine replacement therapy for 12 weeks. Within 60 days of study registration, patients undergo LDCT. After completion of study intervention, patients are followed up at 3, 6, and 12 months.

Conditions

• HIV Infection
• Tobacco-Related Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo LDCT
BEHAVIORAL	Smoking Cessation Intervention	Use Positively Smoke Free - Mobile

Timeline

• Start date: 2023-03-22
• Primary completion: 2026-05-30
• Completion: 2027-03-31
• First posted: 2021-07-02
• Last updated: 2026-01-23

Locations

11 sites across 1 country: United States