HCV-Smoking Cessation Study

Not Applicable

Completed

• Conditions: Hepatitis C; Smoking Cessation
• Interventions: Behavioral: Cognitive Behavioral Counseling

• Registration Number: NCT05466981
• Lead Sponsor: Prisma Health-Upstate

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.

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 Timeline

• Study Start: 2020-11-23
• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Primary Completion: 2021-11-11
• Study Completion: 2021-11-11
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Current smokers with an HCV infection	Cognitive Behavioral Counseling	Persons who currently smoke cigarettes and are also HCV RNA+

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Prisma Health Internal Medicine Clinic; 🇺🇸 Greenville, South Carolina, United States