HCV-Smoking Cessation Study

NCT ID: NCT05466981

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2021-11-11

Brief Summary

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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

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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.

Conditions

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Hepatitis C Smoking Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Current smokers with an HCV infection

Persons who currently smoke cigarettes and are also HCV RNA+

Group Type EXPERIMENTAL

Cognitive Behavioral Counseling

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irene Pericot-Valverde, PhD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health

Alain Litwin, MD

Role: STUDY_DIRECTOR

Prisma Health

Locations

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Prisma Health Internal Medicine Clinic

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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00103095

Identifier Type: -

Identifier Source: org_study_id

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