Last updated on November 2019

Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke


Brief description of study

The single greatest health behavior change that could improve cardiovascular morbidity and associated mortality is to assist people living with HIV/AIDS who smoke to quit. The investigators will use a factorial design to evaluate the most promising behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit smoking.

Detailed Study Description

The investigators propose a factorial design strategy to evaluate the effects, individually and in combination, of the most promising pharmaco- and behavioral cessation therapies available for PLWH according to the review of the extant literature for HIV-infected and general population smokers. The sizable cohort and prospective design will also permit the investigators to evaluate the effects of tobacco use, treatment, and cessation on a panel of soluble biomarkers of inflammation that are likely contributors to cardiac morbidity and mortality in people living with HIV/AIDS. The specific aims of the study are:

Primary Aim 1: Compare varenicline to placebo on rates of 7-day point prevalence abstinence (PPA) at 24 weeks in smokers with HIV/AIDS. It is hypothesized that rates of smoking abstinence at week 24 will be higher in those treated with varenicline compared to placebo.

Primary Aim 2: Compare Positively Smoke Free to low intensity, brief counseling on rates of 7-day PPA at 24 weeks in smokers with HIV/AIDS. It is hypothesized that rates of smoking abstinence at week 24 will be higher in those treated with Positively Smoke Free compared to brief counseling.

Secondary Aim: Compare Positively Smoke Free + varenicline to the other two study conditions outlined above on rates of 7-day PPA in smokers with HIV/AIDS at 24 weeks. It is hypothesized that the effect of PSF with varenicline is greater than the effect of PSF or varenicline alone.

Exporatory Aim: Explore the effect of successful cessation/smoking abstinence on levels of cardiac specific biomarkers, nicotine biomarkers, generalized markers of inflammation, lipids, coagulation and monocyte/macrophage activation. The investigators hypothesize that smoking cessation will be associated with significant reductions in levels of these biomarkers and monocyte/macrophage activation.

Clinical Study Identifier: NCT02460900

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