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Smoking Cessation Intervention for HIV/AIDS

Q: Is there a precedent for using preventive measures such as smoking cessation, nicotine replacement and LDCT in clinical studies?

<p>At the moment, 3 Phase 3 trials for Prevention (<a href="https://www.withpower.com/clinical-trials/smoking-cessation">smoking cessation</a>, nicotine replacement, LDCT) are actively being conducted. While most of these studies are centered in Fridley, <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a> there exist 195 distinct research sites operating clinical trials concerning prevention and smoking suppression initiatives.</p>

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

Receiving antiretroviral therapy and CD4 count at least 200 cells/uL within 6 months of registration (due to increased risk of LDCT false positivity with CD4 count < 200cells/uL)

Possession of a smartphone that can support Positively Smoke Free Mobile (PSF-M) (> 95% of subjects had eligible phones in prior trials although researchers will include specific study screening questions assessing for adequate smartphone for the intervention)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 months and 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 on HIV medication and my CD4 count is at least 200.

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I own a smartphone compatible with the PSF-M app.

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I am between 45 and 80 years old.

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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

Incidental findings on low dose computed tomography

Level of adherence with Positively Smoke Free - Mobile and adherence with low dose computed tomography screening

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

~2720

Smoking Cessation Intervention

2005

N/A

~1800

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,567 Total Patients Enrolled

AIDS Malignancy ConsortiumLead Sponsor

63 Previous Clinical Trials

9,526 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals past the age of fifty being incorporated into this clinical research?

"This trial is only available for participants aged 45 to 80. There are 151 trials offering assistance to those below 18 years of age and 503 clinical studies accommodating patients over 65."

Answered by AI

Is there a way I can become part of this experiment?

"This research project seeks to recruit 100 participants between the ages of 45 and 80 that have HIV/AIDS."

Answered by AI

Is there a precedent for using preventive measures such as smoking cessation, nicotine replacement and LDCT in clinical studies?

"At the moment, 3 Phase 3 trials for Prevention (smoking cessation, nicotine replacement, LDCT) are actively being conducted. While most of these studies are centered in Fridley, Minnesota there exist 195 distinct research sites operating clinical trials concerning prevention and smoking suppression initiatives."

Answered by AI

How many individuals are currently participating in this research study?

"This clinical trial's recruitment period has closed; it was initially uploaded on April 15th 2023 and last revised by researchers on March 10th. If you're seeking to participate in other trials, 618 studies related to HIV/AIDS require participants while 65 investigations focusing on smoking cessation, nicotine replacement therapy, or low-dose computed tomography are currently looking for volunteers."

Answered by AI

Are there still vacancies available for participants in this investigative trial?

"According to the clinicaltrials.gov database, this experiment is not actively recruiting at this time as it was last edited on March 10th 2023. Although there are no more openings for this trial, 683 other medical studies remain open to new participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04949464.

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