Patch Study - Intervention for HIV Positive Smokers
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | May 2016 |
| End Date: | April 2021 |
| Contact: | Maria Jose Miguez, MD |
| Email: | mjmiguez@fiu.edu |
Biobehavioral Intervention for Smokers Living With HIV (Human Immunodeficiency Virus)
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.
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.
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).
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).
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
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