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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
4 sessions will be provided with a trained counselor who will discuss the participant's' smoking habits with them and strategies to help them quit. The first session is in-person, lasts for 20 minutes, and typically happens when the participant comes to the HIV clinic to pick up their medication. Sessions 2 through 4 are over the telephone and last for 15 minutes each. These occur 1 week, 4 weeks, and 8 weeks after the first session.
Brief messages that give tips to help quit smoking will be sent to participants' cell phones using WeChat. 3 messages per day will be sent for the first week, 2 messages per day for the next 3 weeks, 1 message per day for the next 1 week, and 1-2 messages per week for the rest of the time
Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).
Participants will be offered a self-help guide with information about quitting smoking.
Boston Medical Center
Boston, Massachusetts, United States
Guangxi Medical University
Guangxi, Nanning, China
Number of Participants With Biochemically Verified Smoking Cessation
Defined as not smoking during the previous 7 days, not even a puff, validated by measuring CO level (\<8ppm) in the exhaled air
Time frame: 12 weeks
Number of Participants That Self Reported Smoking Cessation at 8 Weeks
Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Time frame: 8 weeks
Number of Participants That Self Reported Smoking Cessation at 12 Weeks
Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Time frame: 12 weeks
Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks
Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Time frame: baseline, 8 weeks
Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks
Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Time frame: baseline, 12 weeks
Number of Quit Attempts at 8 Weeks
Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Time frame: 8 weeks
Number of Quit Attempts at 12 Weeks
Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Time frame: 12 weeks
Adherence to Antiretroviral Treatments (ART) at 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.
Time frame: 8 weeks
Adherence to Antiretroviral Treatments (ART) at 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.
Time frame: 12 weeks
Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 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.
Time frame: 12 weeks
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