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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; HIV
• Intervention / Treatment: Drug: Bupropion; Behavioral: Positively smoke free; Other: Brief advice to quit smoking

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).

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Kenya
  • Nairobi
    • Kilimani, Nairobi, Kenya
      • Center for International Health, Education, and Biosecurity (CIHEB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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	Up to 36 Weeks

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Publications and helpful links

General Publications

• Keith A, Dong Y, Shuter J, Himelhoch S. Behavioral Interventions for Tobacco Use in HIV-Infected Smokers: A Meta-Analysis. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):527-33. doi: 10.1097/QAI.0000000000001007.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Cytochrome P-450 Enzyme Inhibitors; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Bupropion
• Other Study ID Numbers: HP-00077523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No