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

• ClinicalTrials.gov Identifier: NCT03342027
• Recruitment Status: Recruiting
• First Posted: November 14, 2017
• Last Update Posted: January 20, 2022
• Sponsor: University of Maryland, Baltimore
• Information provided by (Responsible Party): Seth Himelhoch, University of Maryland, Baltimore

Study Description

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 a methadone maintenance program 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.

Condition or disease	Intervention/treatment	Phase
Hiv; Opioid Dependence; Smoking Cessation	Drug: Bupropion; Behavioral: Positively smoke free; Other: Brief advice to quit smoking	Phase 3

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 in a methadone maintenance program 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. The study will be conducted in a methadone maintenance clinic for several reasons. First, smoking rates are shockingly high in this setting, and the need for effective tobacco treatment is enormous. Second, there is great synergy in providing behavioral and pharmacological treatment for smoking cessation interventions to clients who are already receiving a pharmacological intervention (i.e., methadone) with concomitant substance use counseling. Third, people in methadone maintenance come regularly to receive treatment which is likely to enhance smoking cessation treatment follow-up and completion. 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). Additionally, the study will conduct an implementation costs assessment to provide rigorously obtained approximations of total implementation costs of each intervention tested in this trial.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: 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.
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Optimizing Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya
• Actual Study Start Date: August 1, 2020
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

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 Name: 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 Name: 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)

Outcome Measures

Primary Outcome Measures :

1. 7-day abstinence [ Time Frame: 36 months ]
   defined as self-reported no smoking in the past 7 days + CO<7 ppm

Eligibility Criteria

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

Criteria

Inclusion Criteria

• Chart diagnosis of a HIV and receiving methadone maintenance treatment at recruitment clinic.
• Age 18 years and older
• Scores >7 ppm of expired carbon monoxide (CO) on the Smokelyzer
• Currently self-report smoking approximately 5 cigarettes per day.
• Motivation to quit (score 5-8 on the Abrams and Briener Readiness to Quit Ladder)
• Able to read and speak English
• 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.

Contacts and Locations

Contacts

Contact: Wendy Potts, MS; (410) 706-2490; wpotts@som.umaryland.edu

Contact: Seth Himelhoch, MD; (410) 706-2490

Locations

Kenya

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

Kilimani, Nairobi, Kenya

Contact: Patience Oduor 0780445855 POduor@mgic.umaryland.edu

Sponsors and Collaborators

University of Maryland, Baltimore

More Information

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.

• Responsible Party: Seth Himelhoch, Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT03342027
• Other Study ID Numbers: HP-00077523
• First Posted: November 14, 2017
• Last Update Posted: January 20, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Bupropion; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors