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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people living with HIV/AIDS quit smoking. It seeks to determine if an algorithm (a step-by-step decision guide) can assist doctors in selecting the best medications for smoking cessation. The trial includes two groups: one will use the algorithm treatment with a phone-based support service, while the other will use only the phone support. The trial seeks participants who have smoked at least 5 cigarettes a day for the past month and are currently receiving HIV care at specific clinics. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

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 is the safety track record for these treatments?

In a previous study, researchers found no specific safety concerns with the Smoking Cessation Algorithm for people living with HIV/AIDS. This tool helps doctors select the best methods to assist patients in quitting smoking. It has been used without reports of major problems or side effects.

For those considering joining this trial, available data suggests the algorithm is well-tolerated. It has been tested in similar situations and appears safe for participants. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores a new way to help HIV/AIDS patients quit smoking using a personalized algorithm. Unlike the traditional approach of referring patients to quitlines, which offer general phone-based support, this trial adds a layer of personalization by recommending a specific pharmacotherapy regimen to healthcare providers based on the patient's needs. This tailored approach aims to enhance the effectiveness of smoking cessation efforts for a population that faces unique health challenges. By combining personalized treatment with existing quitline support, researchers hope to improve quit rates and offer a more effective solution for smoking cessation in HIV/AIDS patients.

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

Research has shown that the Algorithm Treatment, a special program designed to help people with HIV quit smoking, can achieve better results than usual methods. Participants in this trial may receive this program, which creates personalized plans for each individual, potentially improving their health. Alternatively, some participants will be referred to quitlines, which are telephone-based tobacco cessation services. The program's success in helping people stop smoking makes it a promising option for those managing HIV/AIDS. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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

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

Enrollment in the CNICS clinical cohort.

Receiving HIV care at the UAB, UW or Fenway Health clinics and not anticipating changing clinics over the next six months

Exclusion Criteria

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

I am currently undergoing treatment to stop smoking.

You are currently experiencing extreme mental distress, such as feeling suicidal or manic, or have recently consumed drugs or alcohol that may affect your decision-making ability.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8607828/

Effectiveness of a Smoking Cessation Algorithm Integrated ... A smoking cessation pharmacotherapy recommendation algorithm integrated into HIV primary care may increase treatment utilization and smoking abstinence.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4505746/

An Algorithm Approach to Determining Smoking Cessation ... The purpose of this study was to evaluate the feasibility and effects of a novel proactive algorithm-based intervention in an HIV/AIDS clinic.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03670316?cond=hiv&aggFilters=status%3A

Effectiveness of a Smoking Cessation Algorithm Integrated ... Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03670316

Effectiveness of a Smoking Cessation Algorithm Integrated ... PLWH smokers engaged in treatment lose more years of life due to smoking now than to HIV disease. Although PLWH smokers engaged in HIV care typically see a ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421002871

Effectiveness of a smoking cessation algorithm integrated ... A smoking cessation pharmacotherapy recommendation algorithm integrated into HIV primary care may increase treatment utilization and smoking abstinence.

6. withpower.com withpower.com/trial/phase-4-7-2020-9d205

Smoking Cessation Algorithm for HIV/AIDS Patients 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 ...