NCT03342027

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HIV
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Bupropion	medication for smoking cessation
BEHAVIORAL	Positively smoke free	an 8 session, tailored behavioral intervention for treating tobacco dependence
OTHER	Brief advice to quit smoking	Standardized brief advice to quit smoking (standard of care)

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2017-11-14
• Last updated: 2025-02-05
• Results posted: 2025-02-05

Locations

1 site across 1 country: Kenya