Patch Study - Intervention for HIV Positive Smokers

Study Overview
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Brief Summary
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The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. To test researchers proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines + nicotine replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.

Detailed Description
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The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. This will be accomplished by assessing: 1) pre-trial plasma levels, 2) doing genotyping, which to researchers knowledge has not been used in cessation studies among people living with HIV (PLWH), and 3) providing tailored feedback to the participants, based on the assumption that the higher the knowledge and perception of risk, the higher the interest in modifying a risky behavior(s). To test researchers proposed model based in proven smoking prevention and control methods 600 PLWH ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines will consist on brief advice + nicotine replacement therapy, versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy (NRT). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day. The knowledge gained here has the potential to provide a more complete bio-behavioral model to the intervention field. The proposed study if successful will provide a new tailored, replicable, and manual-based intervention for people living with HIV. It can also provide much need it information in regards to key mediators and moderators of smoking cessation interventions in this vulnerable population. Researchers long term goal is to reduce the burden of one of the most devastating causes of morbi-mortality in researchers time and improve their quality of life. The study could also pave the path to use a similar model to tailor smoking interventions for other populations (e.g., menthol users, older women, adolescents, older adults).

Official Title
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Biobehavioral Intervention for Smokers Living With HIV (Human Immunodeficiency Virus)

Conditions
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Smoking Cessation, HIV

Intervention / Treatment
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* Other: Combination Therapy
* Other: Standard Care Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infected smokers 18 years of age and older Fluent in English or Spanish Able to consent Ready to quit smoking Exclusion Criteria: Psychotic or disabling psychiatric disorders Six months post-myocardial infarction or stroke Diabetes requiring insulin Treatment for vascular problems Non-treated hypertension, Severe liver or kidney disease History of allergies to the nicotine patches Severe eczema or psoriasis Temporal-mandibular joint disease or dental appliances Pregnant women or women that are breastfeeding Subjects participating in other interventions/research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Combination Therapy<br>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjust as need it | Other: Combination Therapy<br>* Brief behavioral intervention The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.<br>* Other names: Nicoderm, Nicorette;|
| Active Comparator: Standard Care Intervention<br>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used. Standard Flavored gums will be used as needed for 10 weeks. | Other: Standard Care Intervention<br>* Brief Behavioral Intervention The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | 3 months | 
| Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | 6 months | 
| Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Outcomes | The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves: CD4 (counts and percentage). HIV Viral load (logs). Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute). Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches]. In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) | 6 months | 
| Number of Participants With Verified Continuous Abstinence | Verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | 3 months | 
| Prevalence of Side Effects-safety | Total number of self reported side effects from Baseline through 6 months. | Baseline-6 months | 
| Change in Clinical Outcomes | The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves: CD4 (counts and percentage). HIV Viral load (logs). Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute). Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches]. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) - In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey. | 12 months | 
| Number of Participants With Verified Continuous Abstinence | verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | 6 months | 
| Number of Participants With Verified Continuous Abstinence | verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | 12 months | 
| Prevalence of Side Effects-safety | Total number of self reported side effects from 6 through 12 months. | 6 through 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Replacement, Smoking, HIV