People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.
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: esrc.kenya@amref.org Address: Langata Road PO Box 27691-00506 Nairobi, Kenya
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Used for smoking cessation and alcohol reduction
An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
Matched to cystine
Standardized brief advice to quit smoking (standard of care)
Mathari National Teaching and Referral Hospital
Nairobi, Kenya
Riruta Health Centre
Nairobi, Kenya
7-day point prevalence abstinence (PPA)
Defined as self-reported no smoking in the past 7 days + Carbon Monoxide (CO)\<7 ppm
Time frame: 36 months
Dried blood spot phosphatidylethanol (PEth)
PEth level of less than 50ng/dl for cessation from heavy drinking linked (P30D)
Time frame: 36 months
Timeline Follow-Back (TLFB)
denial of self-reported heavy drinking days (denying any prior 7-day period with \>7 drinks or any single day with 4 drinks) for the past 30 days
Time frame: 36 months
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