HCV-Smoking Cessation Study

Study Overview
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Brief Summary
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A 12-week study for patients who are being treated for Hepatitis C and would like to quit smoking. During the 12 weeks of Hepatitis C treatment, the research team will have counseling sessions with the participants to discuss challenges related to Hepatitis C and smoking.

Detailed Description
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A 12-week smoking cessation intervention addressing concurrently HCV and smoking cessation The Standard of care for HCV is 12 weeks of oral medication with 3 in-person provider/laboratory visits throughout. This study utilizes both in-person and phone counseling and health education sessions. Each session will address a different topic related to HCV, smoking, and how both smoking and HCV affect health and quality of life.

Official Title
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Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus

Conditions
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Hepatitis C, Smoking Cessation

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥18 years old) Current HCV infection (HCV RNA+) Current cigarette smoking Patients in contemplation / preparation stage of change Exclusion Criteria: Inability to speak/read English, as materials will be provided in English Current suicidal ideation as determined by the PHQ-9, requiring a greater level of clinical care Severe medical or psychiatric disability that prevents participant from ability to comprehend or consent to study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: We conducted a single-arm pilot study in order to test the feasibility and preliminary efficacy of a smoking cessation intervention for people with HCV while they received standard of care treatment: antiviral medication and provider/laboratory visits.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Current smokers with an HCV infection<br>Persons who currently smoke cigarettes and are also HCV RNA+ | Behavioral: Cognitive Behavioral Counseling<br>* The intervention consisted of 12 weeks of HCV treatment combined with smoking cessation pharmacotherapy and brief behavioral counseling conducted by a LMSW. The brief behavioral counseling consisted of cognitive behaioral components and was provided by phone and in-person. The intervention followed these 5 phases: increase motivation to quit smoking, quit attempt, maintain short-term abstinence, and lapse and relapse prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of cigarettes smoked per day (CPD) | We will track the number of cigarettes the participant smokes per day at each weekly visit, then compare the CPD at baseline during week 0 to the end of treatment at week 12. | baseline (week 0) to end of treatment (week 12) | 
| Change in Fagerstrom Test for Nicotine Dependence (FTND) score | We will calculate the participant's FTND score at the baseline visit during week 0 and compare it to their FTND score at the end of treatment visit during week 12. | baseline (week 0) to end of treatment (week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score | We will calculate the participant's PHQ-9 score at the baseline visit during week 0 and compare it to their PHQ-9 score at the end of treatment visit during week 12. | baseline (week 0) to end of treatment (week 12) | 
| Number of quit attempts | We will measure the number of quit attempts made throughout the intervention from baseline to end of treatment. | baseline (week 0) to end of treatment (week 12) |