HCV-Smoking Cessation Study

Sponsor

Prisma Health-Upstate (Other)

Overall Status

Completed

CT.gov ID

NCT05466981

Collaborator

(none)

Enrollment

Location

Arm

11.6

Actual Duration (Months)

0.9

Patients Per Site Per Month

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
Hepatitis C Smoking Cessation	Behavioral: Cognitive Behavioral Counseling	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

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus

Actual Study Start Date :

Nov 23, 2020

Actual Primary Completion Date :

Nov 11, 2021

Actual Study Completion Date :

Nov 11, 2021

Arms and Interventions

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.

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.

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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.

Responsible Party:

Prisma Health-Upstate

ClinicalTrials.gov Identifier:

NCT05466981

Other Study ID Numbers:

00103095

First Posted:

Jul 20, 2022

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis C

Hepatitis

Study Results

No Results Posted as of Jul 20, 2022