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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current smokers with an HCV infection | Experimental | Persons who currently smoke cigarettes and are also HCV RNA+ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Pericot-Valverde, PhD | Prisma Health | Principal Investigator |
| Alain Litwin, MD | Prisma Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health Internal Medicine Clinic | Greenville | South Carolina | 29605 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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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.
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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) |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |