Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya
2 other identifiers
interventional
580
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 28, 2022
CompletedStudy Start
First participant enrolled
May 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2025
CompletedJuly 2, 2025
June 1, 2025
1.6 years
February 16, 2022
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (4)
Proportion of participants who have abstained from tobacco use at 1 month
1 month
Proportion of participants who have abstained from tobacco use at 3 months
3 months
Proportion of participants who have abstained from tobacco use at 6 months
6 months
Median HIV Viral load by abstinence status
12 months
Study Arms (3)
Brief Intervention
EXPERIMENTALParticipants will receive one time tobacco use cessation counseling and quitline number.
Intensive Intervention
EXPERIMENTALParticipants will receive intensive behavioral counseling spread over 12 sessions, Nicotine Replacement Therapy and Bupropion, and the quitline number.
Cross-over Intervention
EXPERIMENTALParticipants 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.
Interventions
Counseling sessions will be given in person
Given orally
Given transdermally
Given orally
Eligibility Criteria
You may qualify if:
- Human immunodeficiency virus (HIV)-seropositive,
- Age \>=18 years
- Currently taking or initiating antiretroviral therapy (ART)
- Access to mobile phone for phone or text follow up visit (intensive intervention only)
- Able to read or be read short message service (SMS) messages (intensive intervention only).
- Current tobacco users, who have used tobacco in the past 7 days;
- Must have smoked at least 100 cigarettes in lifetime, and at least 5 cigarettes per day biochemically verified by expired Carbon Monoxide (CO) \>= 5-6 parts per million (ppm).
You may not qualify if:
- Advanced HIV disease, age \< 18 years
- Unable to provide verbal informed consent
- Unwilling to be contacted by clinic for follow up
- Myocardial Infarction (MI) in the 2 weeks prior to signing consent
- Pregnant (NRT and Bupropion may be contraindicated).
- Patients for whom Bupropion is contraindicated (e.g. history of seizures, recent use of Monoamine oxidase (MAO) inhibitors, breastfeeding, and whose ART protocol present, as per prescription guidance, contraindications).
- Prior disclosure of HIV status to the phone owner for those who use phones will be required to prevent inadvertent disclosure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Kenya Medical Research Institutecollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Kenya Medical Research Institute (KEMRI)
Kisumu, 40100, Kenya
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stella Bialous, Dr PH
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2022
First Posted
April 28, 2022
Study Start
May 16, 2023
Primary Completion
January 7, 2025
Study Completion
January 7, 2025
Last Updated
July 2, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share