Smoking Cessation Interventions for People with HIV/AIDS

Overseen By Jennifer Cantrell, DrPH, MPA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: New York University

Must not be taking: Tobacco cessation medications

Disqualifiers: Pregnancy, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 24-32 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people living with HIV quit smoking by testing different methods to make quitting easier and more successful. Participants will try various combinations of support, including motivational counseling, text messages, nicotine replacement therapy (such as patches), and peer mentoring. The goal is to identify the best strategies to integrate into regular HIV care, making quitting smoking more accessible and less burdensome. This trial suits individuals in the NYC metro area who have HIV, smoke at least five cigarettes a day, and are already receiving HIV medical care. As a Phase 4 trial, the treatment is FDA-approved and proven effective, focusing on understanding how it benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you are not currently using any tobacco cessation medications like nicotine patches, gum, or bupropion. If you are using these, you would need to stop before participating.

What is the safety track record for these treatments?

Previous studies have shown that nicotine replacement therapy (NRT), including patches, lozenges, and gum, is generally well-tolerated. These therapies provide lower nicotine levels to help manage cravings and withdrawal symptoms when quitting smoking. Reports highlight that combining NRTs, like patches and lozenges, can be more effective for quitting than using one type alone. Safety data indicate these products are safe for most users.

The Multiphase Optimization Strategy (MOST) has been used in other studies focusing on HIV care, but specific safety data about MOST itself is less detailed. However, the trial's later phase suggests that earlier evaluations found the strategy reasonably safe. This trial aims to improve smoking cessation outcomes, and each intervention component, such as motivational interviewing and peer mentoring, is generally considered low-risk.

Participants can feel reassured that past research has shown the treatments being tested to be safe, and they are being carefully monitored for any adverse effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these smoking cessation interventions for people with HIV/AIDS because they integrate a variety of support mechanisms tailored to individual needs, which could enhance effectiveness. Unlike traditional methods that might rely solely on nicotine replacement therapy (NRT) or counseling, this approach combines options like text messaging, peer mentoring, and motivational interviewing. This multiphase optimization strategy (MOST) aims to determine the best combination of these components, offering a personalized approach that could significantly improve cessation rates and overall health outcomes for individuals with HIV/AIDS.

What evidence suggests that this trial's treatments could be effective for smoking cessation in people with HIV/AIDS?

Research has shown that combining nicotine replacement therapies (c-NRT), such as a nicotine patch and gum, helps people quit smoking more effectively than using a single method. Those who used both methods achieved higher success rates at quitting smoking at 4, 12, 26, and 52 weeks. In this trial, some participants will receive c-NRT as part of their treatment. The Multiphase Optimization Strategy (MOST) is another approach tested in this trial to customize smoking cessation treatments for people living with HIV. MOST aims to improve quit rates by identifying the best mix of support methods, such as counseling and text messaging. Both c-NRT and MOST offer promising ways to help people with HIV quit smoking, and this trial will evaluate their effectiveness. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for smokers living with HIV who are seeking to quit smoking. It aims to integrate effective smoking cessation strategies into their HIV clinical care.

Inclusion Criteria

Status as HIV+

Currently smokes ≥ 5 CPD, on average, in past month, carbon monoxide ≥ 7 ppm and positive salivary cotinine

Is engaged in HIV clinical care

Exclusion Criteria

I am currently using medication to help me stop smoking.

Pregnant or nursing and plans to be in next 6 months

Has a past 6-month psychiatric hospitalization or psychiatric emergency room visit does not have a functioning mobile phone that can receive text messages

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various smoking cessation interventions including Motivational Interviewing, Peer Mentoring, Text-messaging, and Combination Nicotine Replacement Therapy

24-32 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for smoking abstinence and quit attempts

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Combination NRT
• Multiphase Optimization Strategy (MOST)

Trial Overview The study tests a combination of interventions: skills-based text messaging, motivational interviewing counseling, peer mentoring, and nicotine replacement therapy (NRT) to help participants quit smoking.

How Is the Trial Designed?

Group I: Condition 9 Experimental Treatment 1 Intervention

Participants will receive the Core Component and Motivational Interviewing Counseling intervention.

Group II: Condition 8 Experimental Treatment 3 Interventions

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.

Group III: Condition 7 Experimental Treatment 2 Interventions

Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.

Group IV: Condition 6 Experimental Treatment 2 Interventions

Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.

Group V: Condition 5 Experimental Treatment 1 Intervention

Participants will receive the Core Component and Peer Mentoring intervention.

Group VI: Condition 4 Experimental Treatment 2 Interventions

Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.

Group VII: Condition 3 Experimental Treatment 1 Intervention

Participants will receive the Core Component and Text Messaging intervention.

Group VIII: Condition 2 Experimental Treatment 1 Intervention

Participants will receive the Core Component and Combination-NRT intervention.

Group IX: Condition 16 Experimental Treatment 4 Interventions

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.

Group X: Condition 15 Experimental Treatment 3 Interventions

Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.

Group XI: Condition 14 Experimental Treatment 3 Interventions

Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.

Group XII: Condition 13 Experimental Treatment 2 Interventions

Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.

Group XIII: Condition 12 Experimental Treatment 3 Interventions

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.

Group XIV: Condition 11 Experimental Treatment 2 Interventions

Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.

Group XV: Condition 10 Experimental Treatment 2 Interventions

Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.

Group XVI: Condition 1 Active Control 1 Intervention

Participants will receive the Core Component.

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a pilot study involving 60 participants living with HIV, the integration of a smoking cessation decisional algorithm during routine clinic visits led to a significant reduction in smoking, from an average of 14.4 cigarettes per day to 7.1 cigarettes per day over three months (p = .001).

The study also found that 45% of participants made a 24-hour quit attempt and 65% used cessation medication, demonstrating the algorithm's effectiveness in engaging smokers in cessation therapies, despite some delays in medication access due to insurance issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery and implementation of an algorithm for smoking cessation treatment for people living with HIV and AIDS. Cropsey, KL., Bean, MC., Haynes, L., et al.[2020]

In a study involving 209 HIV-positive smokers, three different smoking cessation interventions showed similar effectiveness, with cessation rates ranging from 15% to 29%, indicating that various methods can be integrated into HIV treatment settings.

Factors such as employment status, a strong desire to quit, and lower mood disturbance were associated with higher chances of quitting smoking, suggesting that these personal characteristics may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of smoking cessation treatments provided in HIV clinical care settings. Humfleet, GL., Hall, SM., Delucchi, KL., et al.[2022]

A review of 22 studies highlighted that treatment competence is the strongest predictor of nonadherence to antiretroviral medications, with an odds ratio of 2.0, indicating that patients' understanding and ability to manage their treatment significantly affect their adherence levels.

Nonadherence to antiretroviral therapy is linked to a twofold increase in the risk of treatment failure, emphasizing the critical need for patient education and simplified treatment regimens, especially for those facing a high pill burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based review of treatment-related determinants of patients' nonadherence to HIV medications. Atkinson, MJ., Petrozzino, JJ.[2009]

In a survey of 150 HIV-infected smokers from two South African clinics, 42% expressed an intention to quit smoking within the next year, highlighting a significant desire for cessation support.

The majority of respondents (82%) had previously attempted to quit, with counseling and nicotine replacement being the most preferred strategies, indicating that integrating smoking cessation interventions into HIV care could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intention to quit smoking among human immunodeficiency virus infected adults in Johannesburg, South Africa. Shapiro, AE., Tshabangu, N., Golub, JE., et al.[2021]

Smoking cessation interventions for people living with HIV (PLWH) are effective, particularly those using cell phone technology, which showed a high likelihood of success with odds ratios between 4.33 and 5.6.

Successful smoking cessation in PLWH led to clinically significant health improvements, including reductions in systolic blood pressure, weight gain, and increased CD(4+) T-cell counts, highlighting the importance of tailored interventions that address individual needs and co-occurring issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking-cessation interventions in people living with HIV infection: a systematic review. Moscou-Jackson, G., Commodore-Mensah, Y., Farley, J., et al.[2022]

A study of 444 HIV-positive smokers revealed that low self-efficacy in quitting smoking and a higher desire to quit are linked to greater nicotine dependence, highlighting psychological factors in smoking behavior.

The research found that older Hispanic Americans are less likely to be nicotine dependent, suggesting that smoking cessation interventions should be customized to address the unique needs of different racial and ethnic groups within the HIV-positive population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-positive smokers considering quitting: differences by race/ethnicity. Lloyd-Richardson, EE., Stanton, CA., Papandonatos, GD., et al.[2023]

A smoking cessation intervention delivered via cellular telephone significantly increased smoking abstinence rates among HIV-positive individuals, with a 36.8% quit rate compared to 10.3% in the usual care group.

Participants receiving the cellular telephone intervention were 3.6 times more likely to quit smoking than those receiving standard care, highlighting the effectiveness of tailored support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a proactive cellular telephone intervention for smokers living with HIV/AIDS. Vidrine, DJ., Arduino, RC., Lazev, AB., et al.[2022]

Algorithm-based treatments (AT) for smoking cessation showed promising results among people living with HIV, with significant increases in self-efficacy and medication use, and reductions in daily cigarette consumption among 100 participants.

Racial differences were noted in quit goals and success rates: White smokers aiming for complete abstinence had higher quit rates, while African Americans with non-abstinence goals had better outcomes, highlighting the need for tailored approaches in smoking cessation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Trial Examining African American and White Responses to Algorithm-Guided Smoking Cessation Medication Selection in Persons Living with HIV. Valera, P., McClernon, FJ., Burkholder, G., et al.[2022]

Over 40% of people with HIV in the U.S. smoke, and smoking significantly reduces life expectancy even more than HIV itself, highlighting the urgent need for integrated tobacco dependence treatment in HIV care.

The article proposes a practical 3-step framework (Ask-Advise-Connect) for healthcare providers to help patients quit smoking, emphasizing the use of pharmacotherapy like varenicline and behavioral interventions to improve cessation success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Use and Treatment of Tobacco Dependence Among People With Human Immunodeficiency Virus: A Practical Guide for Clinicians. Reddy, KP., Kruse, GR., Lee, S., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39693492/

A randomized trial for combination nicotine replacement ... The purpose of this study was to evaluate the efficacy of combination nicotine replacement therapy (c-NRT) for smoking cessation among people with HIV (PWH) in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04994444

Preloading With Nicotine Replacement Therapy in HIV ... This study will be the first to examine the feasibility and initial efficacy of a novel intervention using NRT preloading to improve smoking cessation outcomes ...

3. journals.lww.com journals.lww.com/ebp/fulltext/2023/05000/is_combination_nicotine_replacement_therapy_more.21.aspx

Is combination nicotine replacement therapy more effective... Combination NRT resulted in significantly higher quit rates at 6 to 12 months than single-form NRT (14 RCTs, N=11,356; 17.4% vs 13.9%; risk ratio [RR] 1.25; 95% ...

4. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/a-randomized-trial-for-combination-nicotine-replacement-therapy-f

A randomized trial for combination nicotine replacement ... Objective: The purpose of this study was to evaluate the efficacy of combination nicotine replacement therapy (c-NRT) for smoking cessation ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-7634-z

Combined nicotine patch with gum ... - BMC Public Health Smokers given 8 weeks of combined NRT were more likely to quit smoking at 4, 12, 26 and 52 weeks compared with single NRT.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493148/

Nicotine Replacement Therapy - StatPearls - NCBI Bookshelf Nicotine is available in various forms, including patches, lozenges, inhalers, sprays, and gum. · NRT products contain lower amounts of nicotine ...

7. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-combine-medicines.html

How to Combine Quit Smoking Medicines Using two nicotine replacement medicines (NRTs) together is more likely to help you quit successfully than using one alone. Patch will reduce your withdrawal ...

8. cancer.org cancer.org/cancer/risk-prevention/tobacco/guide-quitting-smoking/nicotine-replacement-therapy.html

Nicotine Replacement Therapy to Help You Quit Tobacco Nicotine replacement therapy (NRT) can help with cravings and physical withdrawal symptoms from quitting smoking and other tobacco products.

9. fda.gov fda.gov/media/167599/download

Developing Nicotine Replacement Therapy Drug Products such NRT combination products would include transdermal patches ... administration must contain data that are adequate to assess the safety and effectiveness of ...

10. aap.org aap.org/en/patient-care/tobacco-control-and-prevention/youth-tobacco-cessation/nicotine-replacement-therapy-and-adolescent-patients/?srsltid=AfmBOorECdzeHYQ8fRvebNbokSN-AclqfW5hbv3YDvKJIjX7NV0DkNLx

Nicotine Replacement Therapy and Adolescent Patients This page is intended to help pediatricians make informed decisions about using NRT with patients who wish to quit smoking or vaping.