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

Last updated: February 3, 2025
Sponsor: University of Maryland, Baltimore
Overall Status: Completed

Phase

3

Condition

Hiv

Smoking Cessation

Opioid Use Disorder

Treatment

Brief advice to quit smoking

Positively smoke free

Bupropion

Clinical Study ID

NCT03342027
HP-00077523
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 everin lifetime)

  • Pregnant, nursing, or becoming pregnant during the study (pregnancy test)

  • Current use of any medication that would interfere with the protocol in the opinionof a medically accountable Physician

  • Known plans to re-locate or travel away from the study site for more than twoconsecutive 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 toparticipate in the study. This exclusion will be based on a review of theindividual's past medical history and current medical status.

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

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Brief advice to quit smoking
Phase: 3
Study Start date:
August 01, 2020
Estimated Completion Date:
July 25, 2023

Study 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).

Connect with a study center

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

    Kilimani, Nairobi
    Kenya

    Site Not Available

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