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Smoking Cessation Intervention for HIV/AIDS

N/A
Recruiting
Led By Keith M Sigel
Research Sponsored by AIDS Malignancy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets United States Preventive Services Task Force (USPSTF) criteria for LDCT (age 50-80 and >= 20 pack-years smoking) or high-risk but not meeting USPSTF (age 45-49 and >= 20 pack-years smoking)
HIV positive. Documentation of HIV-1 infection by means of any one of the following:
Must not have
Pneumonia or serious lung infection in prior 12 weeks
Contraindication to nicotine replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a smartphone app that may help HIV+ people quit smoking. Positively Smoke Free - Mobile could be a useful smoking cessation tool.

Who is the study for?
This trial is for HIV-positive adults aged 45-80 who smoke and meet criteria for lung cancer screening. They must understand the study, consent to participate, have a compatible smartphone, and not be pregnant or breastfeeding. Exclusions include recent CT scans, history of lung cancer, serious infections, or other health issues that could affect participation.
What is being tested?
The trial tests if a smartphone-based smoking cessation program can help people with HIV quit smoking when combined with lung cancer screening using low-dose computed tomography (LDCT). The goal is to see if this approach is feasible and effective in promoting smoking cessation.
What are the potential side effects?
While there are no direct side effects from the behavior modification intervention itself, nicotine replacement therapy used in smoking cessation may cause mild symptoms like nausea or skin irritation. LDCT involves exposure to low levels of radiation but risks are considered minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 45-80 years old and have a history of heavy smoking.
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I am HIV positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had pneumonia or a serious lung infection in the last 3 months.
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I cannot use nicotine replacement therapy due to health reasons.
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I have had lung cancer in the past.
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I don't have any major illnesses or situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who complete the low dose chest CT scan within 60 days of enrollment
Rate of adherence to Positively Smoke Free - Mobile (PSF-M)
Secondary study objectives
Number of cigarettes smoked per day
Number of participants reporting anxiety related symptoms (concentration problems, memory problems, insomnia and anxiety) on the NCI PROCTCAE
Number of participants using nicotine replacement therapy at 3 months
+2 more
Other study objectives
Incidental findings on low dose computed tomography
Level of adherence with Positively Smoke Free - Mobile and adherence with low dose computed tomography screening

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (smoking cessation, nicotine replacement, LDCT)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2790
Smoking Cessation Intervention
2005
N/A
~1820

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,480 Total Patients Enrolled
AIDS Malignancy ConsortiumLead Sponsor
63 Previous Clinical Trials
9,484 Total Patients Enrolled
Keith M SigelPrincipal InvestigatorAIDS Malignancy Consortium

Media Library

Smoking Cessation Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04949464 — N/A
HIV/AIDS Research Study Groups: Prevention (smoking cessation, nicotine replacement, LDCT)
HIV/AIDS Clinical Trial 2023: Smoking Cessation Intervention Highlights & Side Effects. Trial Name: NCT04949464 — N/A
Smoking Cessation Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04949464 — N/A
~19 spots leftby May 2025