NCT05351606CompletedPhase 4
Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya
Integrating Tobacco Use Cessation Into HIV Care and Treatment in Ministry of Health Facilities in Kisumu County, Kenya
Source: ClinicalTrials.gov · Last updated 2 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 580 (actual)
- First submitted
- 16 Feb 2022
- Start date
- 16 May 2023
- Primary completion date
- 7 Jan 2025
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT05351606
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 580
- From 16 May 2023 to the primary completion date, 7 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial Infarction (MI) in the 2 weeks prior to signing consent
- Prior disclosure of HIV status to the phone owner for those who use phones will be required to prevent inadvertent disclosure.
Other illness
- 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).
Age
- Advanced HIV disease, age \< 18 years
Other
- Unable to provide verbal informed consent
- Unwilling to be contacted by clinic for follow up
- Additional exclusion criteria in the intensive intervention group:
- Pregnant (NRT and Bupropion may be contraindicated).
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kenya Medical Research Institute (KEMRI) Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.