A Phase 4 interventional study of Tobacco Use Cessation Counselling Sessions and Bupropion in Tobacco Use Cessation and Tobacco Use, sponsored by University of California, San Francisco. Completed at 1 site in Kenya. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Prevention
People living with HIV (PLHIV) have higher rates of tobacco use than the general population and higher rates of disease and death compared with PLHIV who do not use tobacco. This project will evaluate the impact of integrating an intensive tobacco use cessation intervention compared to a brief intervention within HIV care clinics in Kisumu County, Kenya.
There is evidence that PLHIV in Africa are more likely to use tobacco than the general population. Kenya is an example of a country coping with the dual epidemic of HIV and tobacco, with an estimated 1.5 million PLHIV and 2.5 million tobacco users. HIV remains one of the country's leading causes of morbidity and mortality, with an estimated 46,000 adults acquired HIV and 25,000 persons died of HIV in 2018. Tobacco use among the general population is estimated to be 11.6% (19.1% among men and 4.5% among women). The impact of tobacco use among PLHIV in Kenya has yet to be fully understood. There has been no research or initiatives in Kenya to support PLHIV to quit tobacco use in a primary care setting, a gap that this study seeks to address. In 2017, Kenya's Ministry of Health launched the National Guidelines for Tobacco Dependence Treatment and Cessation. This project will also examine the integration of the Guidelines' interventions into Ministry of Health HIV care clinics in Kisumu County.
PRIMARY OBJECTIVES:
I. To examine the success of the intensive versus a brief smoking cessation intervention after one year.
SECONDARY OBJECTIVES:
I. To examine the success of the intensive versus a brief smoking cessation intervention at 1 month, 3 months and 6 months.
II. To compare the HIV viral load with abstinence rates for each of the interventions.
STUDY OVERVIEW:
The investigator will conduct a cluster randomized controlled trial at 20 Ministry of Health HIV clinics in Kisumu Kenya, recruiting 580 patients who will be randomized to one of 2 conditions to investigate the effectiveness of an intensive versus a brief intervention aimed at smoking cessation.
Participants will be assessed at baseline, one month, three months, 6 months and 12 months.
62 studies on the registry are indexed under Tobacco Use Cessation; 31 are open to participants now.
This study's enrollment of 580 is above the median of 223 across 61 interventional studies indexed under Tobacco Use Cessation.
Browse Tobacco Use Cessation studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Tobacco inclusion criteria:
Exclusion Criteria:
Additional exclusion criteria in the intensive intervention group:
Participants will receive one time tobacco use cessation counseling and quitline number.
Behavioral: Tobacco Use Cessation Counselling Sessions
Participants will receive intensive behavioral counseling spread over 12 sessions, Nicotine Replacement Therapy and Bupropion, and the quitline number.
Behavioral: Tobacco Use Cessation Counselling Sessions · Drug: Bupropion · Drug: Nicotine patch · Drug: Nicotine lozenge
Participants in the brief arm who are still using tobacco at the end of twelve months were invited to participate in a cross-over study whereby they would, if eligible, would receive the intensive intervention.
Behavioral: Tobacco Use Cessation Counselling Sessions · Drug: Bupropion · Drug: Nicotine patch · Drug: Nicotine lozenge
Counseling sessions will be given in person
Given orally
Also known as: Wellbutrin, Zyban
Given transdermally
Also known as: Nicotine Replacement Therapy (NRT)
Given orally
Also known as: Nicotine lozenge product, NRT
Proportion of participants who have abstained from tobacco use at 12 months
The point prevalent abstinence rate will be reported as the proportion of participants who have abstained from tobacco use and will be dichotomized as either smoking or abstinent. Abstinence is determined by a self-report of 7-day continuous abstinence verified by a salivary cotinine test.
Time frame: 12 months
Proportion of participants who have abstained from tobacco use at 1 month
The point prevalent abstinence rate will be reported as the proportion of participants who have abstained from tobacco use and will be dichotomized as either smoking or abstinent. Abstinence is determined by a self-report of 7-day continuous abstinence verified by a expired carbon monoxide reading of less than 5 parts per million (ppm).
Time frame: 1 month
Proportion of participants who have abstained from tobacco use at 3 months
The point prevalent abstinence rate will be reported as the proportion of participants who have abstained from tobacco use and will be dichotomized as either smoking or abstinent. Abstinence is determined by a self-report of 7-day continuous abstinence verified by a expired carbon monoxide reading of less than 5 parts per million (ppm).
Time frame: 3 months
Proportion of participants who have abstained from tobacco use at 6 months
The point prevalent abstinence rate will be reported as the proportion of participants who have abstained from tobacco use and will be dichotomized as either smoking or abstinent. Abstinence is determined by a self-report of 7-day continuous abstinence verified by a salivary cotinine test.
Time frame: 6 months
Median HIV Viral load by abstinence status
Routine viral load measurement will be taken from the participants at the 12 month visit and the median viral load in copies per ml will be reported along with the interquartile range (IQR) by biochemically verified abstinence status for each group at 12 months.
Time frame: 12 months
Plan to share: No
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University of California, San Francisco