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

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат Cystine
  Used for smoking cessation and alcohol reduction
• Поведенческое Positively Smoke Free
  An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
• Другое Placebo
  Matched to cystine
• Другое Standard of Care
  Standardized brief advice to quit smoking (standard of care)

Первичные конечные точки

• 7-day point prevalence abstinence (PPA) [Срок оценки: 36 months]
• Dried blood spot phosphatidylethanol (PEth) [Срок оценки: 36 months]
• Timeline Follow-Back (TLFB) [Срок оценки: 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Kenya · 2 центра

• Mathari National Teaching and Referral Hospital — Nairobi
• Riruta Health Centre — Nairobi

Публикации

• 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. PMID 37432430
• 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. PMID 39437141

Идентификаторы

NCT: NCT06790342 · IRB24-1626 · 1R01CA288235-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗