Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya

NCT ID: NCT05351606

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 580 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2025-01-07

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.

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Brief Intervention

Participants will receive one time tobacco use cessation counseling and quitline number.

Group Type: EXPERIMENTAL

Tobacco Use Cessation Counselling Sessions

Intervention Type: BEHAVIORAL

Counseling sessions will be given in person

Intensive Intervention

Participants will receive intensive behavioral counseling spread over 12 sessions, Nicotine Replacement Therapy and Bupropion, and the quitline number.

Group Type: EXPERIMENTAL

Tobacco Use Cessation Counselling Sessions

Intervention Type: BEHAVIORAL

Counseling sessions will be given in person

Bupropion

Intervention Type: DRUG

Given orally

Nicotine patch

Intervention Type: DRUG

Given transdermally

Nicotine lozenge

Intervention Type: DRUG

Given orally

Cross-over Intervention

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.

Group Type: EXPERIMENTAL

Tobacco Use Cessation Counselling Sessions

Intervention Type: BEHAVIORAL

Counseling sessions will be given in person

Bupropion

Intervention Type: DRUG

Given orally

Nicotine patch

Intervention Type: DRUG

Given transdermally

Nicotine lozenge

Intervention Type: DRUG

Given orally

Interventions

Tobacco Use Cessation Counselling Sessions

Counseling sessions will be given in person

Intervention Type: BEHAVIORAL

Bupropion

Given orally

Intervention Type: DRUG

Nicotine patch

Given transdermally

Intervention Type: DRUG

Nicotine lozenge

Given orally

Intervention Type: DRUG

Other Intervention Names

Wellbutrin; Zyban; Nicotine Replacement Therapy (NRT); Nicotine lozenge product; NRT

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stella Bialous, Dr PH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Kenya Medical Research Institute (KEMRI)

Kisumu, , Kenya

Countries

Kenya

Other Identifiers

1U01CA261620-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22639

Identifier Type: -

Identifier Source: org_study_id