Patch Study - Intervention for HIV Positive Smokers

Not Applicable

Completed

Conditions: Smoking Cessation
HIV

Interventions: Other: Combination Therapy
Other: Standard Care Intervention

Registration Number: NCT02982772

Lead Sponsor: dr. maria miguez

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 488

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Combination Therapy	Combination Therapy	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
Standard Care Intervention	Standard Care Intervention	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.

Primary Outcome Measures

Name	Time	Method
Rates of Smoking Cessation	12 months	verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Verified Continuous Abstinence	12 months	verified continuous abstinence using a breathalyzer carbon monoxide \< 10ppm
Prevalence of Side Effects-safety	6 through 12 months	Total number of self reported side effects from 6 through 12 months.
Change in Clinical Outcomes	12 months	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.