Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya

This study was reviewed and approved for data analysis by the University of Chicago.

The research portion of this study was also submitted to and is pending approval from:

Board Name: AMREF ETHICAL AND SCIENTIFIC REVIEW COMMITTEE (ESRC) Board Affiliation: The AMREF ESRC is affiliated with AMREF Health Africa and accredited by National Commission for Science, Technology and Innovation (NACOSTI) since 200 Phone: +254 20 699 4000 Email: [email protected]

Address:

Langata Road PO Box 27691-00506 Nairobi, Kenya

Inclusion criteria

• Confirmed chart diagnosis of HIV
• At least 18 years or age
• Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.
• Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)
• Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse/heavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or >7 drinks/week over the past 30 days
• Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)
• Willingness to accept behavioral and/or pharmacologic tobacco and alcohol treatment
• Willingness and ability to provide informed consent to participate.

Exclusion criteria

• Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment
• Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)
• History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations
• Pregnant, nursing, or becoming pregnant during the study
• Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician
• Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale
• Unstable psychiatric illness
• Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period
• Expected survival of less than 6 months.