Status:
COMPLETED
Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Kenya Medical Research Institute
National Cancer Institute (NCI)
Conditions:
Tobacco Use Cessation
Tobacco Use
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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).
- Tobacco inclusion criteria:
- 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).
Exclusion
- Advanced HIV disease, age \< 18 years
- Unable to provide verbal informed consent
- Unwilling to be contacted by clinic for follow up
- Additional exclusion criteria in the intensive intervention group:
- 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.
Key Trial Info
Start Date :
May 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2025
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT05351606
Start Date
May 16 2023
End Date
January 7 2025
Last Update
July 2 2025
Active Locations (1)
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1
Kenya Medical Research Institute (KEMRI)
Kisumu, Kenya, 40100