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

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.

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.