Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya
NCT05351606 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 580
Last updated 2025-07-02
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.
Conditions
- Tobacco Use Cessation
- Tobacco Use
Interventions
- BEHAVIORAL
-
Tobacco Use Cessation Counselling Sessions
Counseling sessions will be given in person
- DRUG
-
Given orally
- DRUG
-
Nicotine patch
Given transdermally
- DRUG
-
Nicotine lozenge
Given orally
Sponsors & Collaborators
-
Kenya Medical Research Institute
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Stella Bialous, Dr PH · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-16
- Primary Completion
- 2025-01-07
- Completion
- 2025-01-07
- FDA Drug
- Yes
Countries
- Kenya
Study Locations
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