Clinical trial NCT02982772: Patch Study - Intervention for HIV Positive Smokers
Official title: Biobehavioral Intervention for Smokers Living With HIV (Human Immunodeficiency Virus)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
HIV
Keywords: Nicotine Replacement
Smoking
HIV
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2016-12-05
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Rates of Smoking Cessation
timeFrame: 3 months
measure: Rates of Smoking Cessation
timeFrame: 6 months
measure: Rates of Smoking Cessation
timeFrame: 12 months
Secondary outcomes:
measure: Change in Clinical Outcomes
timeFrame: 6 months
measure: Number of Participants With Verified Continuous Abstinence
timeFrame: 3 months
measure: Prevalence of Side Effects-safety
timeFrame: Baseline-6 months
measure: Change in Clinical Outcomes
timeFrame: 12 months
measure: Number of Participants With Verified Continuous Abstinence
timeFrame: 6 months
measure: Number of Participants With Verified Continuous Abstinence
timeFrame: 12 months
measure: Prevalence of Side Effects-safety
timeFrame: 6 through 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: Florida International University
name: Maria Jose Miguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Guillermo Castro, MD
role: STUDY_DIRECTOR
References: