Hepatitis CNCT05466981
HCV-Smoking Cessation Study
A study testing Cognitive Behavioral Counseling in people with Hepatitis C and Smoking Cessation, run by Prisma Health-Upstate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Smoking Cessation
- What is being tested?
- Cognitive Behavioral Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2020to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years old)
- Current HCV infection (HCV RNA+)
- Current cigarette smoking
- Patients in contemplation / preparation stage of change
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health Internal Medicine Clinic
Greenville, South Carolina, 29605
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis C, Smoking Cessation
- Being tested
- Cognitive Behavioral Counseling
- Medical subject headings
- Hepatitis C, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Current smokers with an HCV infection | Experimental | Persons who currently smoke cigarettes and are also HCV RNA+ Receives: Behavioral: Cognitive Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline (week 0) to end of treatment (week 12)
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline (week 0) to end of treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start23 Nov 2020
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Pericot-Valverde, PhD, Principal investigator, Prisma HealthAlain Litwin, MD, Study director, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466981
- Sponsor's protocol ID
- 00103095
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT05466981
- Acronym / sponsor ID
- 00103095
- Conditions
- Hepatitis C, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Current smokers with an HCV infection | Experimental | Behavioral: Cognitive Behavioral CounselingPersons who currently smoke cigarettes and are also HCV RNA+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years old)
- Current HCV infection (HCV RNA+)
- Current cigarette smoking
- Patients in contemplation / preparation stage of change
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral CounselingThe 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. | Behavioural | Current smokers with an HCV infection |
Primary outcome
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.
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.
2 secondary outcomes
Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score
Time frame: baseline (week 0) to end of treatment (week 12)
Number of quit attempts
Time frame: baseline (week 0) to end of treatment (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Pericot-Valverde, PhD principal investigator
Prisma Health
Alain Litwin, MD study director
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Counseling in people with Hepatitis C and Smoking Cessation, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of cigarettes smoked per day (CPD) (time frame: baseline (week 0) to end of treatment (week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.