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

Phase 3

Not yet recruiting

• Conditions: HIV; Tobacco Use; Alcohol Use Disorder
• Interventions: Drug: Cystine; Behavioral: Positively Smoke Free; Other: Standard of Care; Other: Placebo

• Registration Number: NCT06790342
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Study Start: 2025-08-01
• Primary Completion: 2029-08-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Confirmed chart diagnosis of HIV
2. At least 18 years or age
3. 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.
4. Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)
5. 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
6. Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)
7. Willingness to accept behavioral and/or pharmacologic tobacco and alcohol treatment
8. Willingness and ability to provide informed consent to participate.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental: Cystine (CYT) + Positively Smoke Free	Cystine	Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Cystine--used for smoking cessation and alcohol reduction
Experimental: Cystine (CYT) + Positively Smoke Free	Positively Smoke Free	Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Cystine--used for smoking cessation and alcohol reduction
Experimental: Cystine + Standard of Care	Cystine	Cystine--used for smoking cessation and alcohol reduction Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation
Experimental: Cystine + Standard of Care	Standard of Care	Cystine--used for smoking cessation and alcohol reduction Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation
Experimental: Placebo + Positively Smoke Free	Positively Smoke Free	Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Placebo--matched to bupropion
Experimental: Placebo + Positively Smoke Free	Placebo	Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Placebo--matched to bupropion
Placebo Comparator: Placebo + Standard of Care.	Placebo	Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format
Placebo Comparator: Placebo + Standard of Care.	Standard of Care	Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format

Primary Outcome Measures

Name	Time	Method
7-day point prevalence abstinence (PPA)	36 months	Defined as self-reported no smoking in the past 7 days + Carbon Monoxide (CO)\<7 ppm
Dried blood spot phosphatidylethanol (PEth)	36 months	PEth level of less than 50ng/dl for cessation from heavy drinking linked (P30D)
Timeline Follow-Back (TLFB)	36 months	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

Trial Locations

Locations (2)

Mathari National Teaching and Referral Hospital; 🇰🇪 Nairobi, Kenya

Riruta Health Centre; 🇰🇪 Nairobi, Kenya