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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 months and 6 months

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

~2740

Smoking Cessation Intervention

2005

N/A

~1800