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

NCT ID: NCT03342027

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-07-25

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.

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).

Conditions

HIV; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bupropion + Positively Smoke Free

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

Group Type: EXPERIMENTAL

Bupropion

Intervention Type: DRUG

medication for smoking cessation

Positively smoke free

Intervention Type: BEHAVIORAL

an 8 session, tailored behavioral intervention for treating tobacco dependence

Bupropion + Standard of Care

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

Group Type: EXPERIMENTAL

Bupropion

Intervention Type: DRUG

medication for smoking cessation

Brief advice to quit smoking

Intervention Type: OTHER

Standardized brief advice to quit smoking (standard of care)

Placebo + Positively Smoke Free

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

Group Type: EXPERIMENTAL

Positively smoke free

Intervention Type: BEHAVIORAL

an 8 session, tailored behavioral intervention for treating tobacco dependence

Placebo + Standard of Care.

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

Group Type: PLACEBO_COMPARATOR

Brief advice to quit smoking

Intervention Type: OTHER

Standardized brief advice to quit smoking (standard of care)

Interventions

Bupropion

medication for smoking cessation

Intervention Type: DRUG

Positively smoke free

an 8 session, tailored behavioral intervention for treating tobacco dependence

Intervention Type: BEHAVIORAL

Brief advice to quit smoking

Standardized brief advice to quit smoking (standard of care)

Intervention Type: OTHER

Other Intervention Names

Zyban

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Seth Himelhoch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Kilimani, Nairobi County, Kenya

Countries

Kenya

References

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.

Reference Type: BACKGROUND

PMID: 27028502 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HP-00077523

Identifier Type: -

Identifier Source: org_study_id