Impact of Behavior Modification Interventions & Lung Cancer Screening on

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04949464
Study type	Interventional
Source	AIDS Malignancy Consortium
Contact
Status	Recruiting
Phase	N/A
Start date	March 22, 2023
Completion date	May 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02135419` - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions	Phase 3
Active, not recruiting	`NCT02663856` - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Terminated	`NCT02743598` - Liraglutide for HIV-associated Neurocognitive Disorder	Phase 4
Completed	`NCT02846402` - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda	N/A
Completed	`NCT02659306` - Metformin Immunotherapy in HIV Infection	Phase 1
Completed	`NCT02921516` - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings	N/A
Completed	`NCT02663869` - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Completed	`NCT02564341` - Targeting Effective Analgesia in Clinics for HIV - Intervention	N/A
Active, not recruiting	`NCT02302950` - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas	N/A
Completed	`NCT01830595` - Lactoferrin Treatment in HIV Patients	Phase 2
Terminated	`NCT01902186` - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir	Phase 4
Completed	`NCT01852942` - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV	Phase 2
Terminated	`NCT02109224` - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection	Phase 1
Completed	`NCT02269605` - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment	Phase 1
Completed	`NCT02118168` - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002	N/A
Completed	`NCT01946217` - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials	N/A
Completed	`NCT02527135` - Text Messaging to Improve HIV Testing Among Young Women in Kenya	N/A
Completed	`NCT02525146` - Birmingham Access to Care Study	N/A
Active, not recruiting	`NCT02602418` - Neural Correlates of Working Memory Training for HIV Patients	N/A
Completed	`NCT01805427` - Antiretroviral Therapy and Extreme Weight	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms