HIV/AIDS Mental and Behavioural Disorders Respiratory
Conditions
Interventions
Cytisine
Sponsors
University of Chicago
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Confirmed chart diagnosis of HIV 2.Age =18 years 3.Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired breath CO= 6ppm.? Expired 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: 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.Literacy in either English or Swahili 7.Willingness to accept behavioral and/or pharmacologic tobacco and alcohol treatment,
Exclusion criteria
Exclusion criteria: 1. Ability to provide informed consent to participate. 2. Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment 3. Previous allergic reaction or hypersensitivity to CYT (unlikely since CYT is not available in Kenya) 4. History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations 5. Pregnant, nursing, or becoming pregnant during the study 6. Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician 7. Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale? 8. Unstable psychiatric illness 9. Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period 10. Expected survival of less than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Smoking and Alcohol Abstinence: Primary Outcome and Endpoint Determination. The primary study outcomes of cigarette and alcohol use each involve a self-reported and biochemically confirmed component. For cigarette use, the primary outcomes are self-reported 7-day point-prevalence abstinence and biochemically confirmed abstinence as measured by exhaled carbon monoxide of fewer than six ppm. Abstinence from cigarettes will be based on self-reported 7-day point prevalence abstinence (PPA), i.e. “Have you smoked a cigarette, even a single puff, in the past 7 days?”?65? confirmed by expired CO98% sensitivity and 100% specificity at identifying recent moderate or heavy alcohol use?69? and its specificity and sensitivity of over 88% in research in sub-Saharan Africa.?70? A PEth level >200ng/ml is a widely accepted standard for heavy recent alcohol consumption (the timeframe for this finding is not as clear as the tobacco biomarkers, but expert opinion refers to a time frame “within the past few weeks”),?71? so we will establish a confirmatory level of =200ng/dl for cessation from heavy drinking linked with past 30-day (P30D) TLFB self-report denying any prior 7-day period with >7 drinks or any single day with =4 drinks (see D.4.4.) .?72? The PEth standard does not require adjustment for sex.?71? Discordant results between self-report and PEth will be considered “still with heavy drinking.” | — |
Secondary
| Measure | Time frame |
|---|---|
| Smoking-related measures (Baseline, 12-weeks, 36-weeks). Additional key abstinence outcomes will be continuous abstinence and prolonged abstinence at 36-weeks.?67? The former term is defined as abstinence since quit day, and the latter allows for a 2-week grace period after the original quit day (early slip-ups are common).?67? We will record CO verified 7-day PPA at 12-weeks. Finally, we will collect data on number of quit attempts, longest time abstinent since last study contact, and average #cigs/day. Alcohol-related measures (Baseline, 12-weeks, 36-weeks). Continuous and prolonged cessation from heavy alcohol use at 36-weeks according to definitions provided above. AUDIT score.?67,72? PEth-confirmed (<20ng/ml [the abstinence cut point])?71? P30D continuous and prolonged abstinence from alcohol, % P30D abstinent, average (mean and/or median) P30D drinks per drinking day, average (mean and/or median) P30D drinks per day, P30D %heavy drinking days.?73? We also will examine raw PEth values as a secondary outcome adjusting for BMI and hemoglobin.?74? Mediators. Based on mechanisms of action we will evaluate putative mediators of CYT’s impact on smoking and drinking including craving and withdrawal. We have also selected putative mediators of PSF’s impact on smoking, guided by PSF’s social cognitive theory model,?75? especially tobacco and alcohol knowledge and abstinence, motivation to quit, and self-efficacy to resist temptations. Craving. Tobacco Craving Questionnaire (TCQ-SF)?76? and Penn Alcohol Craving Scale (PACS).?77? Withdrawal. Shiffman-Jarvik Withdrawal Questionnaire (SWQ)?78? and the Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-AR).?79? Tobacco and alcohol knowledge. Standardized items from the Adult Use of Tobacco Survey.?65? We have also validated a scale in Kenyan PWH probing for knowledge on the relationships of tobacco and alcohol with cancer. Self-efficacy. Smoking Temptation Scale?80? and Alcohol Abstinenc | — |
Countries
Kenya
Contacts
Public ContactWalter Mchembere
CoPI and study coordinator
Outcome results
None listed