Clinical trial NCT06790342: Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
Official title: Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: HIV
Tobacco Use
Alcohol Use Disorder
Keywords: HIV
Tobacco Cessation
Alcohol Reduction
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Maryland
First posted: 2025-01-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 7-day point prevalence abstinence (PPA)
timeFrame: 36 months
measure: Dried blood spot phosphatidylethanol (PEth)
timeFrame: 36 months
measure: Timeline Follow-Back (TLFB)
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Mathari National Teaching and Referral Hospital
city: Nairobi
country: Kenya
facility: Riruta Health Centre
Study officials:
affiliation: University of Chicago
name: Seth Himelhoch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rigotti NA, Benowitz NL, Prochaska J, Leischow S, Nides M, Blumenstein B, Clarke A, Cain D, Jacobs C. Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2023 Jul 11;330(2):152-160. doi: 10.1001/jama.2023.10042.
citation: Himelhoch SS, Koech E, Omanya AA, Oduor P, Mchembere W, Masai TW, Bennett ME, Li L, Potts W, Ojoo S, Shuter J. Efficacy of Smoking Cessation Interventions among People with HIV in Kenya. NEJM Evid. 2024 Nov;3(11):EVIDoa2400090. doi: 10.1056/EVIDoa2400090. Epub 2024 Oct 22.