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

Tobacco Use Clinical Trial

Official title:

Integrating Tobacco Use Cessation Into HIV Care and Treatment in Ministry of Health Facilities in Kisumu County, Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351606
• Other study ID #: 22639
• Secondary ID: 1U01CA261620-01
• Status: Recruiting
• Phase: Phase 4
• Start date: May 16, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Stella Bialous, Dr PH
• Phone: (415) 502-3353
• Email: stella.bialous[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

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 Criteria:

• 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.

Related Conditions & MeSH terms

• Tobacco Use
• Tobacco Use Cessation

Intervention

Behavioral:
• Tobacco Use Cessation Counselling Sessions
Counseling sessions will be given in person

Drug:
• Bupropion
Given orally
• Nicotine patch
Given transdermally
• Nicotine lozenge
Given orally

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute (KEMRI)	Kisumu

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Kenya Medical Research Institute, National Cancer Institute (NCI)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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).	1 month
Secondary	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).	3 months
Secondary	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.	6 months
Secondary	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.	12 months