Trial Outcomes & Findings for Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya (NCT NCT03342027)

NCT ID: NCT03342027

Last Updated: 2025-02-05

Results Overview

defined as self-reported no smoking in the past 7 days + CO\<7 ppm

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 300 participants
• Primary outcome timeframe: Up to 36 Weeks
• Results posted on: 2025-02-05

Participant Flow

Participant milestones

Measure	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	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)	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	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)
Overall Study STARTED	74	74	76	76
Overall Study COMPLETED	72	72	74	76
Overall Study NOT COMPLETED	2	2	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya

Baseline characteristics by cohort

Measure	Bupropion + Positively Smoke Free n=72 Participants 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	Bupropion + Standard of Care n=72 Participants 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)	Placebo + Positively Smoke Free n=74 Participants 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	Placebo + Standard of Care. n=76 Participants 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)	Total n=294 Participants Total of all reporting groups
Age, Continuous	41.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	40.8 years STANDARD_DEVIATION 10.1 • n=7 Participants	43.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	44.2 years STANDARD_DEVIATION 10.1 • n=4 Participants	42.5 years STANDARD_DEVIATION 10.2 • n=21 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	48 Participants n=7 Participants	20 Participants n=5 Participants	56 Participants n=4 Participants	144 Participants n=21 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants	20 Participants n=4 Participants	150 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	72 Participants n=5 Participants	72 Participants n=7 Participants	73 Participants n=5 Participants	76 Participants n=4 Participants	293 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Kenya	72 participants n=5 Participants	72 participants n=7 Participants	74 participants n=5 Participants	76 participants n=4 Participants	294 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 36 Weeks

defined as self-reported no smoking in the past 7 days + CO<7 ppm

Outcome measures

Measure	Bupropion + Positively Smoke Free n=72 Participants 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	Bupropion + Standard of Care n=72 Participants 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)	Placebo + Positively Smoke Free n=74 Participants 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	Placebo + Standard of Care. n=76 Participants 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)
7-day Abstinence	4 Participants	17 Participants	15 Participants	29 Participants

Adverse Events

Bupropion + Positively Smoke Free

Serious events: 1 serious events

Other events: 21 other events

Deaths: 3 deaths

Bupropion + Standard of Care

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo + Positively Smoke Free

Serious events: 4 serious events

Other events: 34 other events

Deaths: 3 deaths

Placebo + Standard of Care.

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bupropion + Positively Smoke Free n=72 participants at risk 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	Bupropion + Standard of Care n=72 participants at risk 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)	Placebo + Positively Smoke Free n=74 participants at risk 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	Placebo + Standard of Care. n=76 participants at risk 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)
Surgical and medical procedures Hospitalization	1.4% 1/72 • Number of events 1 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	1.4% 1/72 • Number of events 1 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	2.7% 2/74 • Number of events 2 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	1.3% 1/76 • Number of events 1 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.
Psychiatric disorders Hospitalization	0.00% 0/72 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	0.00% 0/72 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	2.7% 2/74 • Number of events 2 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	1.3% 1/76 • Number of events 1 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.

Other adverse events

Measure	Bupropion + Positively Smoke Free n=72 participants at risk 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	Bupropion + Standard of Care n=72 participants at risk 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)	Placebo + Positively Smoke Free n=74 participants at risk 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	Placebo + Standard of Care. n=76 participants at risk 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)
General disorders Dry Mouth	29.2% 21/72 • Number of events 21 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	33.3% 24/72 • Number of events 24 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	45.9% 34/74 • Number of events 34 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.	36.8% 28/76 • Number of events 28 • We collected SAEs, All-Cause mortality and Adverse Events from the start of the study until the last participant was completed their final appointment. After a participant completes a baseline, they return 2, 4 and 8 weeks later to review any side effects or concerns from the study medication/placebo. 12- and 36-weeks post baseline, additional interviews are completed to review any new side effects, Adverse Events or SAEs.

Additional Information

Dr. Seth Himelhoch

University of Chicago

Phone: 773-834-4314

Email: seth.himelhoch@bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place