HCV-Smoking Cessation Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Current smokers with an HCV infection Persons who currently smoke cigarettes and are also HCV RNA+ |
Behavioral: Cognitive Behavioral Counseling
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.
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Outcome Measures
Primary Outcome Measures
- Change in the number of cigarettes smoked per day (CPD) [baseline (week 0) to end of treatment (week 12)]
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.
- Change in Fagerstrom Test for Nicotine Dependence (FTND) score [baseline (week 0) to end of treatment (week 12)]
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.
Secondary Outcome Measures
- Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score [baseline (week 0) to end of treatment (week 12)]
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.
- Number of quit attempts [baseline (week 0) to end of treatment (week 12)]
We will measure the number of quit attempts made throughout the intervention from baseline to end of treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults (≥18 years old)
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Current HCV infection (HCV RNA+)
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Current cigarette smoking
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Patients in contemplation / preparation stage of change
Exclusion Criteria:
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Inability to speak/read English, as materials will be provided in English
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Current suicidal ideation as determined by the PHQ-9, requiring a greater level of clinical care
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Severe medical or psychiatric disability that prevents participant from ability to comprehend or consent to study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Prisma Health Internal Medicine Clinic | Greenville | South Carolina | United States | 29605 |
Sponsors and Collaborators
- Prisma Health-Upstate
Investigators
- Principal Investigator: Irene Pericot-Valverde, PhD, Prisma Health
- Study Director: Alain Litwin, MD, Prisma Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00103095