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

Trial Summary

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 data supports the effectiveness of the smoking cessation treatment for people with HIV/AIDS?

A study showed that using a smoking cessation algorithm in routine HIV care reduced smoking from an average of 14.4 cigarettes per day to 7.1 cigarettes per day over three months, with 65% of participants using cessation medication and 45% making a 24-hour quit attempt. ^{1 2 3 4 5}

Is Nicotine Replacement Therapy (NRT) safe for people with HIV/AIDS?

The studies reviewed do not provide specific safety data for Nicotine Replacement Therapy (NRT) in people with HIV/AIDS, but NRT is generally considered safe for the general population when used as directed to help quit smoking. ^{1 3 4 6 7}

How is the Multiphase Optimization Strategy (MOST) treatment different for smoking cessation in people with HIV/AIDS?

The Multiphase Optimization Strategy (MOST) is unique because it uses a systematic approach to optimize smoking cessation interventions by tailoring them to the specific needs of people living with HIV/AIDS, considering factors like polysubstance abuse and mental health issues, which are often not addressed in standard treatments. ^{2 3 4 8 9}

What is the purpose of this trial?

This study's long-term goal is to improve clinical outcomes among smokers living with HIV (SLWH) by providing smoking cessation interventions in HIV clinical care that will increase the chances of quitting smoking, limits costs and burden on staff and reach many smokers living with HIV.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tobacco Use and Treatment of Tobacco Dependence Among People With Human Immunodeficiency Virus: A Practical Guide for Clinicians. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A randomized trial of a proactive cellular telephone intervention for smokers living with HIV/AIDS. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Delivery and implementation of an algorithm for smoking cessation treatment for people living with HIV and AIDS. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of smoking cessation treatments provided in HIV clinical care settings. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

An evidence-based review of treatment-related determinants of patients' nonadherence to HIV medications. [2009]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

HIV-positive smokers considering quitting: differences by race/ethnicity. [2023]

8. France pubmed.ncbi.nlm.nih.gov

Intention to quit smoking among human immunodeficiency virus infected adults in Johannesburg, South Africa. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Smoking-cessation interventions in people living with HIV infection: a systematic review. [2022]