HIV, Smoking
Conditions
Brief summary
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 description
The study used a factorial design to randomize participants into 4 conditions: (1) Varenicline (12 weeks) + Positively Smoke Free (PSF) (8 weeks); (2) Varenicline (12 weeks) + Standard of Care (brief advice to quit); (3) Placebo (12 weeks) + Positively Smoke Free (8 weeks); and (4) Placebo (12 weeks) + Standard of Care. The primary outcome was the 7-day point prevalence abstinence (PPA) (\<10mm) at 36 weeks. The specific aims of our proposal are: Primary Aim 1: Compare varenicline to placebo on rates of 7-day point prevalence abstinence (PPA) at 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence at week 36 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 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with Positively Smoke Free compared to brief counseling. Primary Aim 3: 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 36 weeks. We hypothesize 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.
Interventions
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Study Inclusion Criteria: 1. Confirmed chart diagnosis of a HIV and receiving HIV treatment at the participating HIV clinic. 2. Age 18 years or older. 3. Currently self-report smoking 10 cigarettes per day 4. Motivation to quit within the next 6 months (score 5-8 on the Abrams and Briener Readiness to Quit Ladder); 5. Does not meet criteria for current Diagnostic Statistical Manual (DSM) 5 moderate or severe alcohol use disorder or moderate or severe substance use disorder as established by the Mini Neuropsychiatric Interview (MINI) drug and alcohol sections (in the last 3 months) 6. Able to read and speak English 7. Willingness and ability to provide informed consent to participate. Study
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks | 36 weeks | 7-day point-prevalence abstinence based onno self-reported tobacco use (not even a puff) during the 7 days preceding the assessment and a CO ≤10ppm as measured by Covita micro smokrlyzer at week 36. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarker Evaluation | 36 weeks | Effect of smoking abstinence on levels of cardiac specific biomarkers |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline and Standard of Care Participants will receive varenicline and standard of care
Varenicline
Standard of Care | 46 |
| Placebo and Standard of Care Participants will receive placebo and standard of care
Placebo
Standard of Care | 47 |
| Positively Smoke Free and Placebo Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo
Positively Smoke Free
Placebo | 42 |
| Positively Smoke Free and Varenicline Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline
Varenicline
Positively Smoke Free | 49 |
| Total | 184 |
Baseline characteristics
| Characteristic | Varenicline and Standard of Care | Placebo and Standard of Care | Positively Smoke Free and Placebo | Positively Smoke Free and Varenicline | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 10.7 | 52.0 years STANDARD_DEVIATION 8.5 | 55.3 years STANDARD_DEVIATION 8.1 | 52.6 years STANDARD_DEVIATION 10.3 | 52.8 years STANDARD_DEVIATION 9.6 |
| Cigarettes smoked per day | 11.7 cigarettes per day STANDARD_DEVIATION 6.8 | 11.0 cigarettes per day STANDARD_DEVIATION 5.3 | 11.6 cigarettes per day STANDARD_DEVIATION 7.1 | 10.8 cigarettes per day STANDARD_DEVIATION 5.7 | 11.3 cigarettes per day STANDARD_DEVIATION 6.2 |
| Employed | 16 Participants | 15 Participants | 8 Participants | 7 Participants | 46 Participants |
| Fagerstrom Test For Nicotine Dependence (FTND) | 4.9 units STANDARD_DEVIATION 1.8 | 4.2 units STANDARD_DEVIATION 2 | 4.4 units STANDARD_DEVIATION 2.1 | 4.4 units STANDARD_DEVIATION 1.9 | 4.5 units STANDARD_DEVIATION 1.9 |
| Less than 12 years of education | 9 Participants | 14 Participants | 13 Participants | 23 Participants | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 43 Participants | 40 Participants | 44 Participants | 165 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 2 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 0 Participants | 2 Participants | 8 Participants |
| Region of Enrollment United States | 46 participants | 47 participants | 42 participants | 49 participants | 184 participants |
| Sex/Gender, Customized Female | 14 participants | 17 participants | 14 participants | 21 participants | 66 participants |
| Sex/Gender, Customized Male | 32 participants | 30 participants | 25 participants | 28 participants | 115 participants |
| Sex/Gender, Customized Transgender | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants |
| Sex/Gender, Customized Unknown | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Smokes mentholated cigarettes | 44 Participants | 46 Participants | 40 Participants | 48 Participants | 178 Participants |
| Taking antiretroviral medication | 42 Participants | 47 Participants | 41 Participants | 47 Participants | 177 Participants |
| Use alcohol in last 30 days | 26 Participants | 26 Participants | 26 Participants | 18 Participants | 96 Participants |
| Use marijuana in last 30 days | 13 Participants | 15 Participants | 6 Participants | 4 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 47 | 0 / 42 | 0 / 49 |
| other Total, other adverse events | 33 / 46 | 30 / 47 | 25 / 42 | 32 / 49 |
| serious Total, serious adverse events | 0 / 46 | 0 / 47 | 0 / 42 | 0 / 49 |
Outcome results
Primary
Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks
7-day point-prevalence abstinence based onno self-reported tobacco use (not even a puff) during the 7 days preceding the assessment and a CO ≤10ppm as measured by Covita micro smokrlyzer at week 36.
Time frame: 36 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varenicline and Standard of Care | Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks | 5 Participants |
| Placebo and Standard of Care | Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks | 4 Participants |
| Positively Smoke Free and Placebo | Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks | 1 Participants |
| Positively Smoke Free and Varenicline | Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks | 5 Participants |
Other Pre-specified
Biomarker Evaluation
Effect of smoking abstinence on levels of cardiac specific biomarkers
Time frame: 36 weeks