HCV-Smoking Cessation Study

Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Hepatitis C
• Intervention / Treatment: Behavioral: Cognitive Behavioral Counseling

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Internal Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: Irene Pericot-Valverde, PhD, Prisma Health; Study Director: Alain Litwin, MD, Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: 00103095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No