Smoking Cessation Algorithm for HIV/AIDS Patients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: University of Alabama at Birmingham
No Placebo Group
Prior Safety Data
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.
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 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 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
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
Treatment Details
Interventions
- Algorithm Treatment (Behavioural Intervention)
- Quitline only (Behavioural Intervention)
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
Research Locations NearbySelect from list below to view details:
University of Alabama, BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
University of WashingtonCollaborator
Harvard UniversityCollaborator
References
Referring Hospitalized Smokers to Outpatient Quit Services: A Randomized Trial. [2023]Linking outpatient cessation services to bedside counseling for hospitalized smokers can improve long-run quit rates. Adding an assisted referral (AR) offer to a tobacco treatment specialist consult service fits the team approach to care in U.S. hospitals.
Clinician-delivered intervention to facilitate tobacco quitline use by surgical patients. [2022]Telephone quitlines that provide counseling support are efficacious in helping cigarette smokers quit and have been widely disseminated; currently, they are underused. Surgery represents a teachable moment for smoking cessation, which can benefit surgical outcomes; however, few surgical patients receive smoking cessation interventions. This study developed and tested a clinician-delivered intervention to facilitate quitline use by adult patients scheduled for elective surgery.
Smoking and HIV: prevalence, health risks, and cessation strategies. [2021]Health hazards due to smoking may undermine benefits of HIV treatment on morbidity and mortality. Over 40% of persons with HIV are current smokers. Health risks of smoking include increases in some HIV-associated infections, cardiovascular disease, some cancers, bacterial pneumonia and other lung disease, and overall mortality. Proven strategies for smoking cessation include various counseling approaches, nicotine replacement therapy and other pharmacotherapy; approaches may need to be individualized to address specific client needs and comorbidities. HIV clinicians and other service providers can have an influential role in screening their patients for smoking and promoting cessation programs to improve health.
Multiple in-hospital counseling increases six-month smoking abstinence among individuals participating in a hospital-initiated smoking cessation program. [2023]A cessation program for hospitalized smokers is an effective strategy to achieve smoking abstinence. The effects of multiple in-hospital counseling sessions on 6-month smoking abstinence require further investigation.
Evaluation of a Smoking Cessation Program for HIV Infected Individuals in an Urban HIV Clinic: Challenges and Lessons Learned. [2021]Introduction. HIV infected persons have high prevalence of smoking and tobacco-associated health risks. Few studies describe smoking cessation programs targeting this population. The Infectious Disease Practice (IDP) in Newark, New Jersey, initiated a smoking cessation program (SCP) for HIV infected smokers. We report participation, abstinence rates, and predictors of abstinence. Methods. This is a prospective cohort study, comparing participants to non-SCP smokers, during April 1, 2011, to October 31, 2012. Intervention included one individualized counseling session with an offer of pharmacotherapy. Univariate and multivariate analyses were performed with self-reported seven-day point prevalence abstinence at six months as primary outcome measure. Results. Among 1545 IDP patients, 774 (51%) were current smokers of whom 123 (16%) participated in the SCP. Mean six-month abstinence rate amongst SCP participants was 16%. A history of cocaine or heroin use was predictive of continued smoking (odds ratio [OR] adjusted 0.20, 95% confidence interval [CI] 0.07-0.55) while smokers in the preparation stage of change were more likely abstinent at six months (OR adjusted 8.26, 95% CI 1.02-66.67). Conclusions. A low-intensity smoking cessation intervention in an HIV treatment setting is effective in a minority of participants. Further research is needed to better address barriers to smoking cessation such as substance use.
Delivery and implementation of an algorithm for smoking cessation treatment for people living with HIV and AIDS. [2020]Compared to the general population, persons living with HIV (PLWH) have higher rates of tobacco use and an increased risk of morbidity from tobacco-related diseases. We conducted a single-arm pilot study of the real-world feasibility of integrating a smoking cessation decisional algorithm within routine clinic visits to engage non-treatment-seeking smokers in smoking cessation therapies. Smokers had an initial study visit during routine care followed by phone contacts at one and three months. Participants completed a baseline survey, followed by the algorithm which resulted in a recommendation for a smoking cessation medication, which was prescribed during the visit. Follow-up phone surveys assessed changes in smoking behavior and use of cessation medications at 1 and 3 months. Participants' (N = 60) self-reported smoking decreased from a baseline average of 14.4 cigarettes/day to 7.1 cigarettes/day at 3 months (p = .001). Nicotine dependence (FTND) decreased from 5.6 at baseline to 3.6 at 3 months (p < .001). Twenty-seven (45%) made a 24-h quit attempt and 39 (65%) used cessation medication. Insurance prior-authorization delayed medication receipt for seven participants and insurance denial occurred for one. Motivational status did not significantly influence outcomes. The algorithm was successful in engaging participants to use cessation medications and change smoking behaviors.
A Pilot Trial Examining African American and White Responses to Algorithm-Guided Smoking Cessation Medication Selection in Persons Living with HIV. [2022]Algorithm-based treatments (AT) may be an effective clinical tool to aid HIV clinicians in prescribing pharmacotherapy to increase smoking cessation among people living with HIV (PLWH). Initial results from AT indicated significant increases in abstinence self-efficacy and medication utilization and declines in cigarettes smoked per day across time. Given historical racial disparities, it is unclear if both African Americans and White smokers would benefit equally from this type of intervention. Thus, the aim of this study was to examine racial differences in response to AT guided smoking cessation for African American and White smokers living with HIV. One hundred PLWH smokers (n = 100) were randomized to receive either AT guided smoking cessation or Treatment as Usual (TAU) which consisted of instructing participants to talk to a provider about smoking cessation assistance when ready to make a quit attempt. Participants were African American (75%) and White (25%) and majority men (71%) who had never been married (56%). African Americans smoked fewer cigarettes and were more likely to smoke mentholated cigarettes compared to White smokers at baseline. African Americans increased their use of other tobacco products (cigars/cigarillos) over time relative to White smokers. A significant interaction between race and quit goal was observed, with White smokers who reported complete abstinence as their goal having higher quit rates, while African Americans who reported a goal other than complete abstinence demonstrating higher quit rates. The increased use of cigars/cigarillos during quit attempts as well as having a goal other than complete abstinence should be considered when applying algorithm based interventions for PLWH African American smokers.
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]Tobacco smoking is common in people living with HIV, but high-quality evidence on interventions for smoking cessation is not available in this population. We aimed to assess the efficacy and safety of varenicline with counselling to aid smoking cessation in people living with HIV.
HIV-positive smokers considering quitting: differences by race/ethnicity. [2023]To better characterize smoking in HIV-positive individuals and to identify critical components of a targeted smoking cessation intervention for multiethnic HIV-positive smokers.
Smoking cessation among women with and at risk for HIV: are they quitting? [2021]Cigarette smoking is an important risk factor for adverse health events in HIV-infected populations. While recent US population-wide surveys report annual sustained smoking cessation rates of 3.4-8.5%, prospective data are lacking on cessation rates for HIV-infected smokers.
Tobacco Use, Use Disorders, and Smoking Cessation Interventions in Persons Living With HIV. [2019]Cigarette smoking remains highly prevalent among persons living with human immunodeficiency virus (HIV), estimated to be 40-75 %, and is significantly higher than what is observed among the general population. Health risks of smoking in this population include cardiovascular disease; bacterial pneumonia, chronic obstructive pulmonary disease, and other respiratory conditions; lung cancer and other malignancies; adverse cognitive and neurological outcomes; low birth weight, preterm birth, and small-for-gestational-age infants; and overall mortality. Smokers with HIV now lose more life years to smoking than they do to the HIV itself. A majority of smokers living with HIV report being interested in cessation, and a significant proportion has made recent quit attempts. There is a general paucity of large, randomized controlled trials of smoking cessation interventions among smokers living with HIV, and among the existing research, cessation rates are suboptimal. Greater resources and effort should be allocated to developing and evaluating cessation treatment modalities for smokers living with HIV. Efforts to individualize and tailor treatments to address specific client needs and comorbidities are warranted. HIV care providers and other health professionals can play a key role in improving health among this population by regularly screening for smoking and promoting cessation.