Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV
- Smoking
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02460900
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Seth Himelhoch, MD, MPH University of Maryland, College Park Principal Investigator: Deanna Kelly, PharmD University of Maryland, College Park
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