Back to resultsHCV-Smoking Cessation Study
Primary Purpose
Hepatitis C, Smoking Cessation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
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
Sites / Locations
- Prisma Health Internal Medicine Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Current smokers with an HCV infection
Arm Description
Persons who currently smoke cigarettes and are also HCV RNA+
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Number of quit attempts
We will measure the number of quit attempts made throughout the intervention from baseline to end of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05466981
Brief Title
HCV-Smoking Cessation Study
Official Title
Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
November 11, 2021 (Actual)
Study Completion Date
November 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Smoking Cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Current smokers with an HCV infection
Arm Type
Experimental
Arm Description
Persons who currently smoke cigarettes and are also HCV RNA+
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the number of cigarettes smoked per day (CPD)
Description
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.
Time Frame
baseline (week 0) to end of treatment (week 12)
Title
Change in Fagerstrom Test for Nicotine Dependence (FTND) score
Description
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.
Time Frame
baseline (week 0) to end of treatment (week 12)
Secondary Outcome Measure Information:
Title
Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score
Description
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.
Time Frame
baseline (week 0) to end of treatment (week 12)
Title
Number of quit attempts
Description
We will measure the number of quit attempts made throughout the intervention from baseline to end of treatment.
Time Frame
baseline (week 0) to end of treatment (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Pericot-Valverde, PhD
Organizational Affiliation
Prisma Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain Litwin, MD
Organizational Affiliation
Prisma Health
Official's Role
Study Director
Facility Information:
Facility Name
Prisma Health Internal Medicine Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HCV-Smoking Cessation Study
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