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

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 3

Conditions: HIV; Smoking Cessation

Treatments: Behavioral: Positively smoke free; Other: Brief advice to quit smoking; Drug: Bupropion

Study type: Interventional

Funder types: Other

Identifiers

NCT03342027

HP-00077523

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Chart diagnosis of HIV at recruitment clinic.
• Age 18 years and older
• Currently self-report smoking approximately 1 cigarette per day.
• Motivation to quit (score 6-8 on the Abrams and Briener Readiness to Quit Ladder)
• Able to read and speak English or Swahili
• 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.
• Based on screening, not meeting criteria for moderate or severe substance disorder as established by the MINI International Neuropsychiatric Interview.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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300 participants in 4 patient groups, including a placebo group

Bupropion + Positively Smoke Free

Experimental group

Description:

Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation bupropion--used for smoking cessation

Treatment:

Drug: Bupropion

Behavioral: Positively smoke free

Bupropion + Standard of Care

Experimental group

Description:

Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation

Treatment:

Drug: Bupropion

Other: Brief advice to quit smoking

Placebo + Positively Smoke Free

Experimental group

Description:

Placebo--matched to bupropion Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation

Treatment:

Behavioral: Positively smoke free

Placebo + Standard of Care.

Placebo Comparator group

Description:

Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format

Treatment:

Other: Brief advice to quit smoking