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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342027
• Other study ID #: HP-00077523
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: July 25, 2023

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Smoking Cessation

Intervention

Drug:
• Bupropion
medication for smoking cessation

Behavioral:
• Positively smoke free
an 8 session, tailored behavioral intervention for treating tobacco dependence

Other:
• Brief advice to quit smoking
Standardized brief advice to quit smoking (standard of care)

Locations

Country	Name	City	State
Kenya	Center for International Health, Education, and Biosecurity (CIHEB)	Kilimani	Nairobi

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

Kenya, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day abstinence	defined as self-reported no smoking in the past 7 days + CO<7 ppm	36 months