Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV

Study Overview
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Brief Summary
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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- 4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit. 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.

Official Title
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Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV

Conditions
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Smoking Cessation, HIV Infections

Intervention / Treatment
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* Behavioral: Sessions with a trained counselor
* Other: Cell phone messages
* Other: Offered nicotine replacement therapy
* Other: Self-help guide for quitting smoking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Self-reported using other smoking cessation program or medication Having a serious health problem that may make them unsuitable to stay in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quit for Life group<br>Participants randomized to this arm will receive a 8 week quit smoking program delivered by trained counselors and messages to their cell phones. Participants will also be offered nicotine replacement therapy (gum or patch, depending on which one is available) and a self-help guide with information about quitting smoking. | Behavioral: Sessions with a trained counselor<br>* 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.<br>Other: Cell phone messages<br>* 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<br>Other: Offered nicotine replacement therapy<br>* Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).<br>Other: Self-help guide for quitting smoking<br>* Participants will be offered a self-help guide with information about quitting smoking.<br>|
| Active Comparator: Control group<br>Participants randomized to this arm will be offered nicotine replacement therapy (gum or patch, depending on which one is available) and a self-help guide with information about quitting smoking. | Other: Offered nicotine replacement therapy<br>* Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).<br>Other: Self-help guide for quitting smoking<br>* Participants will be offered a self-help guide with information about quitting smoking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quit for Life (QFL), Smoking cessation counselors, WeChat messages, Nicotine replacement therapy, Self-help smoking cessation guide, People living with HIV/AIDS (PLH)