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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Bupropion

Criteria

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.