600 Participants Needed

Smoking Cessation Algorithm for HIV/AIDS Patients

KL
KC
Overseen ByKeith Chichester, B.A.
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.12345

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.36789

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.36789

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.3561011

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.3561011

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.
See 2 more

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.
See 1 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Algorithm Treatment plus referral to quitline (AT)Experimental Treatment1 Intervention
will be assigned a pharmacotherapy treatment regimen recommended to their provider.
Group II: Quitline (eTAU)Active Control1 Intervention
will be referred to quitlines, telephone-based tobacco cessation services.

Find a Clinic Near You

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

References

Referring Hospitalized Smokers to Outpatient Quit Services: A Randomized Trial. [2023]
Clinician-delivered intervention to facilitate tobacco quitline use by surgical patients. [2022]
Smoking and HIV: prevalence, health risks, and cessation strategies. [2021]
Multiple in-hospital counseling increases six-month smoking abstinence among individuals participating in a hospital-initiated smoking cessation program. [2023]
Evaluation of a Smoking Cessation Program for HIV Infected Individuals in an Urban HIV Clinic: Challenges and Lessons Learned. [2021]
Delivery and implementation of an algorithm for smoking cessation treatment for people living with HIV and AIDS. [2020]
A Pilot Trial Examining African American and White Responses to Algorithm-Guided Smoking Cessation Medication Selection in Persons Living with HIV. [2022]
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]
HIV-positive smokers considering quitting: differences by race/ethnicity. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Smoking cessation among women with and at risk for HIV: are they quitting? [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Tobacco Use, Use Disorders, and Smoking Cessation Interventions in Persons Living With HIV. [2019]