Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya
Condition: Hiv; Opioid Dependence; Smoking Cessation
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

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 a methadone maintenance
      program 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 in a methadone maintenance program 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. The study will be conducted in a methadone maintenance clinic
      for several reasons. First, smoking rates are shockingly high in this setting, and the need
      for effective tobacco treatment is enormous. Second, there is great synergy in providing
      behavioral and pharmacological treatment for smoking cessation interventions to clients who
      are already receiving a pharmacological intervention (i.e., methadone) with concomitant
      substance use counseling. Third, people in methadone maintenance come regularly to receive
      treatment which is likely to enhance smoking cessation treatment follow-up and completion.
      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).
      Additionally, the study will conduct an implementation costs assessment to provide rigorously
      obtained approximations of total implementation costs of each intervention tested in this
      trial.
    

Intervention name(s): Bupropion; Positively smoke free; Brief advice to quit smoking
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): medication for smoking cessation; an 8 session, tailored behavioral intervention for treating tobacco dependence; Standardized brief advice to quit smoking (standard of care)
Other intervention name(s): Zyban
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Factorial Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment