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

NCT03342027 | Completed Phase 3 Results DMC

• 1 other identifier: HP-00077523
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

HIV; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 7-day Abstinence

  defined as self-reported no smoking in the past 7 days + CO\<7 ppm

  Up to 36 Weeks

Study Arms (4)

Bupropion + Positively Smoke Free

EXPERIMENTAL

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

Drug: Bupropion; Behavioral: Positively smoke free

Bupropion + Standard of Care

EXPERIMENTAL

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

Drug: Bupropion; Other: Brief advice to quit smoking

Placebo + Positively Smoke Free

EXPERIMENTAL

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

Behavioral: Positively smoke free

Placebo + Standard of Care.

PLACEBO COMPARATOR

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

Other: Brief advice to quit smoking

Interventions

Bupropion DRUG

medication for smoking cessation

Also known as: Zyban

Bupropion + Positively Smoke Free; Bupropion + Standard of Care

Positively smoke free BEHAVIORAL

an 8 session, tailored behavioral intervention for treating tobacco dependence

Bupropion + Positively Smoke Free; Placebo + Positively Smoke Free

Brief advice to quit smoking OTHER

Standardized brief advice to quit smoking (standard of care)

Bupropion + Standard of Care; Placebo + Standard of Care.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Based on screening, not meeting criteria for moderate or severe substance disorder as established by the MINI International Neuropsychiatric Interview.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Center for International Health, Education, and Biosecurity (CIHEB)

Kilimani, Nairobi County, Kenya

Location

Related Publications (1)

• 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.

  PMID: 27028502 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Seth Himelhoch
• Organization: University of Chicago

seth.himelhoch@bsd.uchicago.edu

773-834-4314

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 14, 2017
• Study Start: August 1, 2020
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Locations

KE (1)