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Completed

NCT Number: NCT05466981

HCV-Smoking Cessation Study

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.

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Key information

Conditions

Hepatitis C Behavior Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Health Behavior Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Smoking Cessation Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health Internal Medicine Clinic

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Counseling

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.

Primary outcomes

  1. Change in the number of cigarettes smoked per day (CPD)

    Time frame: 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.

  2. Change in Fagerstrom Test for Nicotine Dependence (FTND) score

    Time frame: 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 outcomes

  1. Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score

    Time frame: 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.

  2. Number of quit attempts

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2022
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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