Tobacco Use CessationPhase 4NCT05351606
Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya
A Phase 4 study testing Tobacco Use Cessation Counselling Sessions, Bupropion and Nicotine patch in people with Tobacco Use Cessation and Tobacco Use, run by University of California, San Francisco at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Tobacco Use
- What is being tested?
- Tobacco Use Cessation Counselling Sessions, Bupropion and Nicotine patch
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteKenya
- Study dates
- 16 May 2023to 7 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Tobacco Use Cessation Into HIV Care and Treatment in Ministry of Health Facilities in Kisumu County, Kenya
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To examine the success of the intensive versus a brief smoking cessation intervention after one year.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Tobacco Use Cessation, Tobacco Use
- Being tested
- Tobacco Use Cessation Counselling Sessions, Bupropion, Nicotine patch, Nicotine lozenge
- Keywords
- Integrated Education, Behavioral Counselling, Nicotine Replacement therapy
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco Use Cessation Counselling SessionsBehavioural
Counseling sessions will be given in person
BupropionDrug
Also called Wellbutrin, Zyban
Given orally
Nicotine patchDrug
Also called Nicotine Replacement Therapy (NRT)
Given transdermally
Nicotine lozengeDrug
Also called Nicotine lozenge product, NRT
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Experimental | Participants will receive one time tobacco use cessation counseling and quitline number. Receives: Behavioral: Tobacco Use Cessation Counselling Sessions |
| Intensive Intervention | Experimental | Participants will receive intensive behavioral counseling spread over 12 sessions, Nicotine Replacement Therapy and Bupropion, and the quitline number. Receives: Behavioral: Tobacco Use Cessation Counselling Sessions; Drug: Bupropion; Drug: Nicotine patch; Drug: Nicotine lozenge |
| Cross-over Intervention | Experimental | 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. Receives: Behavioral: Tobacco Use Cessation Counselling Sessions; Drug: Bupropion; Drug: Nicotine patch; Drug: Nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start16 May 2023
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stella Bialous, Dr PH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351606
- Sponsor's protocol ID
- 22639
- Other IDs
- 1U01CA261620-01
- Status last verified
- Jun 2025
- First submitted
- 16 Feb 2022
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Tobacco Use Cessation Into HIV Care and Treatment in Ministry of Health Facilities in Kisumu County, Kenya
- ClinicalTrials.gov ID
- NCT05351606
- Acronym / sponsor ID
- 22639
- Conditions
- Tobacco Use Cessation, Tobacco Use
- Keywords
- Integrated Education, Behavioral Counselling, Nicotine Replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, National Cancer Institute (NCI)
- Study start
- 16 May 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To examine the success of the intensive versus a brief smoking cessation intervention after one year.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Experimental | Behavioral: Tobacco Use Cessation Counselling SessionsParticipants will receive one time tobacco use cessation counseling and quitline number. |
| Intensive Intervention | Experimental | Behavioral: Tobacco Use Cessation Counselling Sessions, Drug: Bupropion, Drug: Nicotine patch, Drug: Nicotine lozengeParticipants will receive intensive behavioral counseling spread over 12 sessions, Nicotine Replacement Therapy and Bupropion, and the quitline number. |
| Cross-over Intervention | Experimental | Behavioral: Tobacco Use Cessation Counselling Sessions, Drug: Bupropion, Drug: Nicotine patch, Drug: Nicotine lozengeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Use Cessation Counselling SessionsCounseling sessions will be given in person | Behavioural | Brief Intervention, Cross-over Intervention, Intensive Intervention |
| BupropionAlso: Wellbutrin, ZybanGiven orally | Drug | Cross-over Intervention, Intensive Intervention |
| Nicotine patchAlso: Nicotine Replacement Therapy (NRT)Given transdermally | Drug | Cross-over Intervention, Intensive Intervention |
| Nicotine lozengeAlso: Nicotine lozenge product, NRTGiven orally | Drug | Cross-over Intervention, Intensive Intervention |
Primary outcome
Proportion of participants who have abstained from tobacco use at 12 months
Time frame: 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.
4 secondary outcomes
Proportion of participants who have abstained from tobacco use at 1 month
Time frame: 1 month
Proportion of participants who have abstained from tobacco use at 3 months
Time frame: 3 months
Proportion of participants who have abstained from tobacco use at 6 months
Time frame: 6 months
Median HIV Viral load by abstinence status
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stella Bialous, Dr PH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tobacco Use Cessation Counselling Sessions, Bupropion and Nicotine patch in people with Tobacco Use Cessation and Tobacco Use, run by University of California, San Francisco at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who have abstained from tobacco use at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.