HIV, Smoking Cessation
Conditions
Brief summary
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The study will randomize 300 participants people living with HIV , who smoke and who are receiving care in HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.
Detailed description
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The will randomize 300 participants people living with HIV, who smoke and who are receiving care at HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care. The study will use a factorial design as it is a highly efficient method of assessing multiple treatments in a single trial with the possibility of saving both time and resources. All participants will be assessed at baseline,12 weeks and 36 weeks with the main outcome being 7-day abstinence (defined as self-reported no smoking in the past 7 days + CO\<7 ppm).
Interventions
DRUGBupropion
medication for smoking cessation
BEHAVIORALPositively smoke free
an 8 session, tailored behavioral intervention for treating tobacco dependence
Standardized brief advice to quit smoking (standard of care)
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for PLWH smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chart diagnosis of HIV at recruitment clinic. * Age 18 years and older * Currently self-report smoking approximately 1 cigarette per day. * Motivation to quit (score 6-8 on the Abrams and Briener Readiness to Quit Ladder) * Able to read and speak English or Swahili * Willingness and ability to provide informed consent to participate
Exclusion criteria
* Has a history of seizure disorder or bulimia nervosa * Recent use of Bupropion (by participant report in the past 3 months) * Previous allergic reaction/hypersensitivity to Bupropion (by participant report ever in lifetime) * Pregnant, nursing, or becoming pregnant during the study (pregnancy test) * Current use of any medication that would interfere with the protocol in the opinion of a medically accountable Physician * Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period. * Expected survival of less than 6 months * Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale. * The study physician believes that the individual is not medially stable enough to participate in the study. This exclusion will be based on a review of the individual's past medical history and current medical status. * Based on screening, not meeting criteria for moderate or severe substance disorder as established by the MINI International Neuropsychiatric Interview.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Abstinence | Up to 36 Weeks | defined as self-reported no smoking in the past 7 days + CO\<7 ppm |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupropion + Positively Smoke Free Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation bupropion--used for smoking cessation
Bupropion: medication for smoking cessation
Positively smoke free: an 8 session, tailored behavioral intervention for treating tobacco dependence | 72 |
| Bupropion + Standard of Care Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation
Bupropion: medication for smoking cessation
Brief advice to quit smoking: Standardized brief advice to quit smoking (standard of care) | 72 |
| Placebo + Positively Smoke Free Placebo--matched to bupropion Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation
Positively smoke free: an 8 session, tailored behavioral intervention for treating tobacco dependence | 74 |
| Placebo + Standard of Care. Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format
Brief advice to quit smoking: Standardized brief advice to quit smoking (standard of care) | 76 |
| Total | 294 |
Baseline characteristics
| Characteristic | Bupropion + Positively Smoke Free | Total | Placebo + Standard of Care. | Placebo + Positively Smoke Free | Bupropion + Standard of Care |
|---|---|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 10.2 | 42.5 years STANDARD_DEVIATION 10.2 | 44.2 years STANDARD_DEVIATION 10.1 | 43.5 years STANDARD_DEVIATION 10.2 | 40.8 years STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 72 Participants | 293 Participants | 76 Participants | 73 Participants | 72 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 72 participants | 294 participants | 76 participants | 74 participants | 72 participants |
| Sex: Female, Male Female | 20 Participants | 144 Participants | 56 Participants | 20 Participants | 48 Participants |
| Sex: Female, Male Male | 52 Participants | 150 Participants | 20 Participants | 54 Participants | 24 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 | 3 / 72 | 0 / 72 | 3 / 74 | 0 / 76 |
| other Total, other adverse events | 21 / 72 | 24 / 72 | 34 / 74 | 28 / 76 |
| serious Total, serious adverse events | 1 / 72 | 1 / 72 | 4 / 74 | 2 / 76 |
Outcome results
Primary
7-day Abstinence
defined as self-reported no smoking in the past 7 days + CO\<7 ppm
Time frame: Up to 36 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupropion + Positively Smoke Free | 7-day Abstinence | 4 Participants |
| Bupropion + Standard of Care | 7-day Abstinence | 17 Participants |
| Placebo + Positively Smoke Free | 7-day Abstinence | 15 Participants |
| Placebo + Standard of Care. | 7-day Abstinence | 29 Participants |