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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hiv, Opioid Dependence, Smoking Cessation

Intervention / Treatment
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* Drug: Bupropion
* Behavioral: Positively smoke free
* Other: Brief advice to quit smoking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Chart diagnosis of a HIV and receiving methadone maintenance treatment at recruitment clinic. Age 18 years and older Scores >7 ppm of expired carbon monoxide (CO) on the Smokelyzer Currently self-report smoking approximately 5 cigarettes per day. Motivation to quit (score 5-8 on the Abrams and Briener Readiness to Quit Ladder) Able to read and speak English 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion + Positively Smoke Free<br>Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation bupropion--used for smoking cessation | Drug: Bupropion<br>* medication for smoking cessation<br>* Other names: Zyban;Behavioral: Positively smoke free<br>* an 8 session, tailored behavioral intervention for treating tobacco dependence<br>|
| Experimental: Bupropion + Standard of Care<br>Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation | Drug: Bupropion<br>* medication for smoking cessation<br>* Other names: Zyban;Other: Brief advice to quit smoking<br>* Standardized brief advice to quit smoking (standard of care)<br>|
| Experimental: Placebo + Positively Smoke Free<br>Placebo--matched to bupropion Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation | Behavioral: Positively smoke free<br>* an 8 session, tailored behavioral intervention for treating tobacco dependence<br>|
| Placebo Comparator: Placebo + Standard of Care.<br>Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format | Other: Brief advice to quit smoking<br>* Standardized brief advice to quit smoking (standard of care)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day abstinence | defined as self-reported no smoking in the past 7 days + CO<7 ppm | 36 months |