Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
- Conditions
- Smoking CessationHIV Infections
- Registration Number
- NCT05020899
- Lead Sponsor
- Boston Medical Center
- Brief Summary
The purpose of this two arm randomized clinical trial (RCT) is to test if a smoking cessation program called Quit for Life (QFL) which was developed by the investigators is effective for patients in China with HIV who smoke. This program is designed to suit the needs of people with HIV who smoke in China.
Eligible participants who provide consent will be randomized into either the QFL or the Control group.
The QFL group will receive a quit smoking program that lasts for 8 weeks with two parts-
1. 4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit.
2. Messages sent to the participants' cell phone using WeChat.
The Control group will not have sessions with a trained counselor or receive messages sent to their cell phone.
Both groups will be offered nicotine replacement therapy and a self-help guide with information about quitting smoking.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- HIV seropositive (by being at the HIV clinic and receiving care)
- Receiving ART treatment from the clinic (by being at the HIV clinic and receiving care)
- Smokes ≥ 5 cigarettes per day
- Able to speak and read in Mandarin Chinese
- Self-reported anticipate to receive ART treatment from the clinic for at least 9 months
- Own a cell phone
- Be willing to set a quit date within 1 month after baseline assessment
- Self-reported using other smoking cessation program or medication
- Having a serious health problem that may make them unsuitable to stay in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants With Biochemically Verified Smoking Cessation 12 weeks Defined as not smoking during the previous 7 days, not even a puff, validated by measuring CO level (\<8ppm) in the exhaled air
- Secondary Outcome Measures
Name Time Method Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks baseline, 8 weeks Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Number of Quit Attempts at 8 Weeks 8 weeks Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks baseline, 12 weeks Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Adherence to Antiretroviral Treatments (ART) at 8 Weeks 8 weeks ART adherence will be assessed with the investigator developed, interviewer-administered 'Adherence to HIV medicine' questionnaire. This questionnaire assesses degree of adherence to taking HIV medicine on time by selecting a number between 0 and 10, where 0 = never on time \[worse outcome\] and 10 = always on time \[best outcome\]. Higher scores are more favorable.
Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks 12 weeks The EuroQol- 5 Dimension (EQ-5D) will be used to assess QOL. It is a questionnaire with five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a scale of 0 to 100 where 0 means the worst health and 100 means the best health the participant can imagine.
Number of Quit Attempts at 12 Weeks 12 weeks Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Number of Participants That Self Reported Smoking Cessation at 8 Weeks 8 weeks Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Number of Participants That Self Reported Smoking Cessation at 12 Weeks 12 weeks Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Adherence to Antiretroviral Treatments (ART) at 12 Weeks 12 weeks ART adherence will be assessed with the investigator developed, interviewer-administered 'Adherence to HIV medicine' questionnaire. This questionnaire assesses degree of adherence to taking HIV medicine on time by selecting a number between 0 and 10, where 0 = never on time \[worse outcome\] and 10 = always on time \[best outcome\]. Higher scores are more favorable.
Trial Locations
- Locations (2)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Guangxi Medical University
🇨🇳Guangxi, Nanning, China
Boston Medical Center🇺🇸Boston, Massachusetts, United States