Smoking Cessation Algorithm for HIV/AIDS Patients

Overseen By Keith Chichester, B.A.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Must not be taking: Smoking cessation treatments

Disqualifiers: Cognitive impairment, Non-English, Unstable, 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: 4

Duration: 12 weeks

600 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine the efficacy of an algorithm designed to recommend smoking cessation-related pharmacotherapy options to the primary care providers of smokers living with HIV/AIDS.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Smoking Cessation Algorithm for HIV/AIDS Patients is an effective treatment?

The available research shows that smoking cessation programs can be effective for HIV patients, but the success rate can vary. For example, a study in Newark, New Jersey, found that 16% of HIV patients who participated in a smoking cessation program were able to quit smoking after six months. This suggests that while the treatment can help some people quit smoking, it may not work for everyone. The study also highlighted that people who were ready to change their smoking habits were more likely to succeed. Compared to other treatments, like multiple counseling sessions in hospitals, which have shown to increase quit rates, the Smoking Cessation Algorithm for HIV/AIDS Patients may need more support to improve its effectiveness. ^{1 2 3 4 5}

What data supports the effectiveness of the Smoking Cessation Algorithm treatment for HIV/AIDS patients?

Research shows that linking outpatient cessation services to hospital counseling can improve quit rates, and telephone quitlines are effective in helping smokers quit. Additionally, a smoking cessation program in an HIV clinic showed some success, with a 16% abstinence rate at six months among participants. ^{1 2 3 4 5}

What safety data exists for the Smoking Cessation Algorithm for HIV/AIDS patients?

The available research does not provide specific safety data for the Smoking Cessation Algorithm itself. However, a pilot study showed that the algorithm successfully engaged participants in using cessation medications and changing smoking behaviors, with no specific safety concerns reported. Additionally, a separate study on the safety of varenicline, a smoking cessation medication, in people living with HIV, was conducted, but the results are not detailed in the provided abstracts. ^{3 6 7 8 9}

Is the Smoking Cessation Algorithm safe for people living with HIV?

The studies reviewed did not report any specific safety concerns related to the Smoking Cessation Algorithm for people living with HIV. The algorithm was used to guide smoking cessation treatments, and participants successfully engaged with the recommended medications and reduced smoking without reported safety issues. ^{3 6 7 8 9}

Is the treatment 'Algorithm Treatment, Quitline only' a promising treatment for helping HIV/AIDS patients quit smoking?

Yes, the treatment is promising because it successfully engaged participants to use smoking cessation medications and reduced their smoking habits. Participants in the study decreased their cigarette use from 14.4 to 7.1 cigarettes per day over three months, and 45% made a 24-hour quit attempt. This shows that the treatment can help HIV/AIDS patients reduce smoking and attempt to quit. ^{3 5 6 10 11}

How is the Smoking Cessation Algorithm treatment unique for HIV/AIDS patients?

The Smoking Cessation Algorithm for HIV/AIDS patients is unique because it integrates a decisional algorithm into routine clinic visits to recommend personalized smoking cessation medications, engaging patients who are not actively seeking treatment. This approach differs from standard treatments by focusing on real-world feasibility and personalized recommendations during regular healthcare interactions. ^{3 5 6 10 11}

Eligibility Criteria

This trial is for adults over 18 who smoke more than 5 cigarettes daily, live in a place where smoking is allowed, are part of the CNICS cohort, and receive HIV care at specific clinics without plans to change. It's not for those with cognitive impairments, non-English speakers, people already in cessation treatment or unstable individuals.

Inclusion Criteria

I am 18 years old or older.

You have smoked at least 5 cigarettes every day for the last month.

Enrollment in the CNICS clinical cohort.

Exclusion Criteria

I do not speak English.

I am able to understand and give consent for my treatment.

I am currently undergoing treatment to stop smoking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an algorithm treatment with prescription cost offsets and quit line referral or enhanced Treatment as Usual with quit line referral only

12 weeks

Regular visits as part of HIV care every 4-6 months

Follow-up

Participants are monitored for smoking cessation outcomes and safety

12 months

Treatment Details

Interventions

• Algorithm Treatment
• Quitline only

Trial Overview The study tests an algorithm that helps doctors choose smoking cessation medications for HIV/AIDS patients against standard Quitline support. The goal is to see if this personalized approach improves quitting rates.

Participant Groups

Group I: Algorithm Treatment plus referral to quitline (AT) Experimental Treatment 1 Intervention

will be assigned a pharmacotherapy treatment regimen recommended to their provider.

Group II: Quitline (eTAU) Active Control 1 Intervention

will be referred to quitlines, telephone-based tobacco cessation services.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Findings from Research

A study involving 898 hospitalized smokers tested the effectiveness of adding an assisted referral (AR) and interactive voice recognition (IVR) follow-up to standard tobacco cessation services, but found no significant increase in smoking abstinence rates at 6 months compared to usual care.

Both groups received similar amounts of bedside counseling, and while a majority of AR+IVR participants accepted referrals for counseling and medications, the overall rates of self-reported 30-day abstinence were nearly identical between the AR+IVR (17.9%) and usual care (17.3%) groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Referring Hospitalized Smokers to Outpatient Quit Services: A Randomized Trial. Fellows, JL., Mularski, RA., Leo, MC., et al.[2023]

A study involving 300 adults scheduled for elective surgery showed that a clinician-delivered intervention significantly increased the use of a telephone quitline, with 19.5% of patients in the intervention group completing a counseling session compared to none in the control group (P < 0.0001).

While the intervention improved quitline engagement, there were no significant differences in self-reported smoking abstinence rates at 30 or 90 days post-surgery, indicating that further research is needed to assess the long-term effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician-delivered intervention to facilitate tobacco quitline use by surgical patients. Warner, DO., Klesges, RC., Dale, LC., et al.[2022]

Over 40% of people with HIV are current smokers, which can significantly increase their risk of HIV-related health issues, including infections, cardiovascular disease, and overall mortality.

Effective smoking cessation strategies, such as counseling and nicotine replacement therapy, should be tailored to individual patient needs, and healthcare providers play a crucial role in promoting these programs to enhance patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking and HIV: prevalence, health risks, and cessation strategies. Lifson, AR., Lando, HA.[2021]

A study of 1943 hospitalized smokers showed that multiple in-hospital counseling sessions significantly increased the likelihood of achieving sustained smoking abstinence at 6 months, with odds ratios of 1.44 for two sessions and 2.02 for three or more sessions.

The effectiveness of this approach remained strong even when accounting for participants who did not continue with post-discharge cessation programs, suggesting that in-hospital counseling is a valuable strategy for reducing smoking prevalence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple in-hospital counseling increases six-month smoking abstinence among individuals participating in a hospital-initiated smoking cessation program. Kuo, CW., Chen, CY., Wu, CH., et al.[2023]

In a study involving 774 HIV-infected smokers, only 123 (16%) participated in a smoking cessation program, which resulted in a six-month abstinence rate of 16% among participants, indicating that while the program had some effectiveness, it reached a small portion of the target population.

Factors influencing smoking cessation included a history of cocaine or heroin use, which was linked to continued smoking, while those in the preparation stage of change had a significantly higher likelihood of quitting, suggesting that readiness to change plays a crucial role in the success of cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Smoking Cessation Program for HIV Infected Individuals in an Urban HIV Clinic: Challenges and Lessons Learned. Chew, D., Steinberg, MB., Thomas, P., et al.[2021]

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]

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]

In a study involving 248 people living with HIV, varenicline combined with counseling significantly increased the rate of smoking cessation compared to placebo, with 15% of participants in the varenicline group achieving continuous abstinence from weeks 9 to 48.

The safety profile of varenicline was favorable, showing a lower incidence of depression in the varenicline group (2%) compared to the placebo group (10%), indicating that varenicline is a safe and effective option for smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Mercié, P., Arsandaux, J., Katlama, C., et al.[2018]

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 study of 747 women (537 HIV-infected and 210 HIV-uninfected) over 10 years, only 16% achieved sustained tobacco cessation, resulting in a low annual cessation rate of 1.8%, which is significantly lower than the general population's rates.

Factors influencing cessation included higher education levels and being of Hispanic origin, while current or former illicit drug use and higher daily cigarette consumption were associated with lower cessation rates, highlighting the need for targeted support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation among women with and at risk for HIV: are they quitting? Goldberg, D., Weber, KM., Orsi, J., et al.[2021]

Cigarette smoking is alarmingly common among people living with HIV, affecting 40-75% of this population, which leads to significant health risks including increased mortality and various diseases.

Despite many smokers with HIV wanting to quit and attempting to do so, there is a lack of effective smoking cessation interventions specifically designed for them, highlighting the need for more tailored treatment options and support from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Use, Use Disorders, and Smoking Cessation Interventions in Persons Living With HIV. Pacek, LR., Cioe, PA.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Referring Hospitalized Smokers to Outpatient Quit Services: A Randomized Trial. [2023]

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

Clinician-delivered intervention to facilitate tobacco quitline use by surgical patients. [2022]

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

Smoking and HIV: prevalence, health risks, and cessation strategies. [2021]

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

Multiple in-hospital counseling increases six-month smoking abstinence among individuals participating in a hospital-initiated smoking cessation program. [2023]

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

Evaluation of a Smoking Cessation Program for HIV Infected Individuals in an Urban HIV Clinic: Challenges and Lessons Learned. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

7. 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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. [2018]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Smoking cessation among women with and at risk for HIV: are they quitting? [2021]

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

Tobacco Use, Use Disorders, and Smoking Cessation Interventions in Persons Living With HIV. [2019]